2016中国国际药物信息大会暨第八届DIA中国年会

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2016中国国际药物信息大会暨第八届DIA中国年会
2016中国国际药物信息大会
暨第八届DIA中国年会
The 8th DIA China Annual Meeting
5月15–18日 | 北京国家会议中心 | 中国
May 15–18 | China National Convention Center, Beijing
迎接法规变革
聚力专业质量
Quality &
Transformation
New Era of Drug
Development
会议手册
Final Program
2016 年 5 月 15 日
2016 年 5 月 16–18 日
15 May, 2016
16–18 May, 2016
—— 会前专题研讨会
—— 会议和展览
– Preconference Workshop
– Conference and Exhibition
主办单位 / Host
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
3
目 录
Table of Contents
DIA欢迎致辞 ...................................................................4
Welcome Messages from DIA...................................................... 4
大会主席欢迎致辞 ...........................................................6
Welcome Message from Program Chair................................... 6
大会指导委员会 ..............................................................9
Steering Committee........................................................................ 9
DIA中国区顾问委员会...................................................13
Advisory Council of China (ACC)...............................................13
主旨讲演嘉宾 ................................................................14
Keynote Speakers...........................................................................14
DIA中国卓越服务奖 ......................................................16
DIA China Excellence In Service Award...................................16
互动交流 .......................................................................20
Networking....................................................................................20
会场与酒店 ................................................................... 21
Venue and Hotel..............................................................................21
北京介绍 ...................................................................... 22
About Beijing..................................................................................22
媒体合作伙伴 ................................................................25
Media Partners................................................................................25
会议一览(中文) ........................................................ 26
Quick Guide to the Program (Chinese)...................................26
会议日程(中文) ........................................................ 28
Program Agenda (Chinese)........................................................28
会议一览(英文) ........................................................ 56
Quick Guide to the Program (English)....................................56
会议日程(英文) ........................................................ 58
Program Agenda (English).........................................................58
壁报 ............................................................................. 91
Poster Program...............................................................................91
讲者索引 ...................................................................... 92
Speaker Index...............................................................................92
参展商介绍....................................................................96
Exhibitor Introduction..................................................................96
会议支持方..................................................................123
Partner Acknowledgements..................................................... 123
日程概览 .....................................................................135
Program at a Glance................................................................... 135
会场地图 .....................................................................141
Floor Plan........................................................................................ 141
P14
P15
P20
P58
Keynote Speaker
Keynote Speaker
Networking
Meeting Schedule
4
DIA 欢迎致辞
WELCOME MESSAGES FROM DIA
Message from DIA’s
Global Chief Executive
On behalf of DIA’s global network, welcome to the DIA China 2016 8th Annual Meeting: Quality & Transformation
– New Era of Drug Development.
In 2016, China marks the first year of its 13th five-year planning cycle, and we are proud to be part of the
remarkable progress and the promise of this new era. The State Council of China and the China Food & Drug
Administration (CFDA) have collaborated on a series of multifaceted regulatory reforms with significant goals,
including improving the quality of drug review and approval, safeguarding the quality of generic drugs, enhancing
regulatory transparency, and encouraging new drug research and development. Globally, these initiatives support
the conduct of multiregional clinical trials, both in and outside of China, and using that data for product registration
in China – creating a clinical, industry, and regulatory framework for quality and innovation for patients in China
and around the world.
This meeting is our opportunity to collectively discuss and advance these and other topics critical to the future
well-being of the health care ecosystem in China and the patients it serves. Many topics are on the very forefront
of science evolving right here in China – genetic testing for rare diseases, next generation sequencing to support
precision medicine, data visualization tools, novel biologic drugs and anti-viral agents – yet they are very real and
here today.
Please don’t miss your opportunity to listen to and learn directly from CFDA leadership at the CFDA Town Hall
on Tuesday. We are grateful for their participation and willingness to exchange information in this open forum;
our thanks as well for the participation the China Center for Food & Drug International Exchange on our Program
Committee. Our regulatory authorities join us to join with so many DIA supporters from industry, academia, and
the patient community to generate innovative approaches to advancing health care worldwide.
Please join me in thanking our dedicated team of volunteer leaders and DIA staff who developed this exceptionally
timely and visionary program.
Thank you for choosing to attend our DIA China 2016 8th Annual Meeting. I hope it is an unforgettable experience!
Barbara Lopez KUNZ
Global Chief Executive
DIA
DIA 欢迎致辞
WELCOME MESSAGES FROM DIA
北京欢迎您,
2016中国国际药物信息大会
暨第八届DIA中国年会
欢迎您!
2016年是中国医药产业新拐点,迎接法规变革,聚力专业质量,提升医药创新的内在驱
动力,加强医药产品的科学监管,成为业界中的关注重点。自2015年开始,中国的医药监管
体系发生了历史性的变革,药品审评审批的改革、鼓励创新药开发、临床试验数据可靠性、
仿制药质量和疗效一致性评价,优先审评审批等方面推出了一系列改革措施,都获得全社会
和业界的赞赏和支持。在全球范围内,国际多中心临床试验的开展, 加快新药在国际上的同步
研发,提高药品监管的能力和国际合作,保障中国和世界人民的健康和用药安全。
本次年会系将关注法规变革对国内研发环境和质量提升带来的巨大影响、挑战和机遇,
并围绕监管科学、临床研究、心血管/肿瘤等具体治疗领域、定量科学、药物警戒,CMC、生
物药品研发、医学事务、医学写作、罕见病、CRO/SMO、早期研发、临床信息技术、伴行诊
断, 集18个学术专题和70余场的学术研讨会于一体。
特别是5月17日周二下午CFDA的专题会场,您一定不能错过! 我们感谢中国食品药品国际
交流中心的协力支持,邀请总局领导和相关人员的参与,利用这个开放论坛,使产业界、学
术界及研究机构共同探讨药监新政对加快创新,提高质量,驱动突破的国家大计。
感谢年会的指导委员会、组织委员会、DIA团队以及所有的志愿者的辛勤工作,让我们期
待一个内涵专业、人才汇聚、富有成效、协作共赢的医药领域的盛会。
2016年5月北京见!
朱立红 工商管理硕士
DIA中国区董事总经理
5
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大会主席欢迎致辞
WELCOME MESSAGE FROM PROGRAM CHAIR
Dear Colleagues,
As the Co-Chair of the program committee, it is my distinguished pleasure to welcome you to Beijing, China and
the 8th Annual Conference of DIA China.
DIA China provides an open forum for the exchange of information across the whole value chain of healthcare
solution development ecosystem. The Annual Conference brings together colleagues from pharmaceutical and
device development companies, CROs, academia, investment and law firms, media outlets, regulatory agencies and
others to promote the innovative endeavor in bringing life-saving medical products and health care technologies
to the people in China and beyond.
This is a historical period of time for China, as the nation is seeking a new growth model predicated on innovation.
Today, more than ever, innovation becomes the center of focus for regulatory agency and industry alike. Through
a series of unprecedented landmark legislative measures from China Food and Drug Administration (CFDA),
a clear shift of attention towards incorporating innovation and international standard quality system in R&D
activities. Therefore it is quite fitting that theme for the conference is “Quality & Transformation – New Era of
Drug Development”
This year’s program is an exciting one with the following themes are of especially importance and relevance:
• Keynote speeches by prominent executives and industry leaders– Dr. Xiaodong Wang, CSO of Beigene and Mr.
Mark Alles, CEO of Celgene. This will be followed by keynote panel session on “Innovation Ecosystem in China”
with panelists consists of thought leaders from various sectors of the industry to address current hot topics.
• Sessions on therapeutic area focused drug development. Highly unmet medical needs areas such as oncology,
diabetes and viral diseases made the list this year. In addition, rare diseases and orphan drug development will
also be covered.
• The CFDA town hall continues to be DIA Annual Conference’s signature program. This year’s discussions is
expected to be unusually exciting since CFDA issued unprecedented series new regulations intend to transform
the pharmaceutical industry in China to focus on quality and innovation.
Over a 3-day period, more than 2000 conference participants will have the opportunity to openly exchange views
over variety of exciting and challenging topics in over 70 different sessions ranging from research and clinical
development, regulatory science, drug safety, to private and public partnerships.
This event is only a reality because of the extraordinary efforts and unwavering dedication of the volunteers
including program committees, the session chairs, speakers, and colleagues at DIA global and China office, and
the most important of all, you, the participants. I look forward to welcoming you to Beijing to partake in this
invigorating and illuminating experience.
Warm regards,
王劲松 医学博士 / Jingsong WANG, MD, PhD
2016中国国际药物信息大会暨第八届DIA中国年会联席主席
Co-Chair of the 8th DIA China Annual Meeting Program
大会主席欢迎致辞
WELCOME MESSAGE FROM PROGRAM CHAIR
尊敬的各位同仁和朋友:
2016年5月我们再次相聚北京,迎来了“中国国际药物信息大会暨第八届药物信息协会(DIA)中国年会”
的开幕。在此,我谨代中国食品药品国际交流中心向来自国内外药品监管机构、科研机构、企业界和学术界的
代表们表示热烈的欢迎和诚挚的谢意!感谢大家与我们共同搭建了DIA中国年会这个交流平台,共同关注中外药
品监管,分享经验,传递信息,交流看法,讨论热点问题;感谢长期以来给予DIA中国年会支持和帮助的各位领
导、专家和朋友们。
本届年会的主题为“迎接法规变革,聚力专业质量”。当前,在食品药品监管制度仍处于创新改革过渡期
的背景下,中国的食品药品监管工作受到社会各界的高度关注,尤其是相关法规的修订与变革。在过去的一年,
食品药品监管部门不断加大信息公开和宣传工作力度,积极推进药品审评审批制度改革、提高药品审评审批标
准,开展仿制药一致性评价、解决药品审评积压、开展药品临床试验数据核查、采用监督抽检的创新科学,严格
按照习总书记“四个最严”的要求和党中央、国务院的改革部署,加快完善统一权威的食品药品安全监管机构体
制机制建设,积极推进药品审评审批制度改革,推进药品上市许可持有人的试点,为促进制药工业由生产大国向
质量强国转变而努力。
中国食品药品国际交流中心致力于为中国食品药品监管事业的发展,开展多层次、广领域的国际合作与交
流。多年来,我们通过举办多种形式的大型国际研讨会/论坛/峰会/学术交流会、广泛开展国际合作项目等,为中
外食品药品企业和相关机构搭建良好的交流与合作的平台。
本届年会将继续秉承分享、开放、创新的精神,邀请中外监管机构、学术界和企业界的代表,围绕大家共
同关注的热点话题进行专业、权威的交流、讨论和成果分享。我期待,通过大会平台的交流讨论,每一位参会代
表都获益。
法规的变革影响深远且意义重大,监管的创新需要科学与技术。变革是发展的契机,是破与立的艺术。在
法规变革的新里程中,让我们通过汇聚社会各界的力量与智慧之泉,共同浇灌食品药品安全之树,守护人类健康
事业。
祝本次大会取得圆满成功!
薛斌
中国食品药品国际交流中心
2016中国国际药物信息大会暨第八届DIA中国年会联席主席
7
DIA 中国
2016年活动
第二期药物研发心脏安全问题研讨班
6月19–20日 | 北京唯实酒店
http://cn16961.eventdove.com/
生物等效性试验的操作规范及自查要领研讨班
6月23–24日 | 北京新疆大厦
http://cn16953.eventdove.com/
第三期美国FDA新药、仿制药报批高级研讨班
7月7–8日 | 北京唯实酒店
http://cn16962.eventdove.com/
2016 药物研发定量科学论坛
8月14–15日 | 北京新疆大厦
http://cn16957.eventdove.com/
中心实验室数据等外源数据的管理与供应商选择研讨班
10月13-14日 | 北京
DIA中国第二届药物研究创新会议
10月24–26日 | 苏州
第六期临床试验项目管理研讨班 - 中高级班
11月16-18日 | 北京
11月21-23日 | 上海/苏州
第二期医学事务/医学沟通/医学联络 高级研讨班
12月 | 上海
亲们~
快来扫一下吧~
中国北京市海淀区海淀大街3号A座16层1618室
邮编: 100080 | 电话: +86 10 5704 2650
中国上海市长宁区仙霞路99号尚嘉中心15楼1590室
邮编: 200051 | 电话: +86 21 6057 7239
DIA中国微信订阅号
传真: +86 10 5704 2651 | Email: [email protected] | www.DIAglobal.org
DIA Global Center 21 Dupont Circle NW, Suite 300, Washington, DC 20036
Basel, Switzerland | Beijing/Shanghai, China | Horsham, PA, USA | Mumbai, India | Tokyo, Japan
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
大会指导委员会
9
STEERING COMMITTEE
王劲松 医学博士
Atlas Venture公司
投资顾问
徐宁 医学博士, 工商管理硕士
再鼎制药执行副总裁,
临床研发及法规事务负责人
陈小祥 医学博士
勃林格殷格翰大中华区
医学发展部副总裁
吕玉真
罗氏(中国)投资有限公司亚太区
法规部门负责人
Jingsong WANG, MD, PhD
Advisor to Atlas Venture
Ning XU, MD, MBA
Executive Vice President,
Head of Clinical Development
and Regulatory Affairs, Zai Lab
Xiaoxiang CHEN, MD
Vice President, Medicine
Development, Greater China,
Boehringer Ingelheim
Janet LV
Head of Regulatory, Asia Pacific,
Roche (China) Ltd.
苏岭 博士
盛德国际律师事务所
生命科学战略顾问
朱立红 工商管理硕士
DIA中国区董事总经理
Ling SU, PhD
Strategic Advisor, Life Sciences,
Sidley Austin LLP
Carol ZHU, MBA
Senior Vice President and
Managing Director,
DIA Greater China
2016中国国际药物信息大会暨第八届DIA中国年会
本届年会以 “迎接法规变革,聚力专业质量” 为主题,以中国近期的法规变革为
背景,围绕监管科学、临床研究、心血管/肿瘤等具体治疗领域、定量科学、药物警
戒,CMC、生物药品研发、医学事务、医学写作、CRO/SMO、早期研发、临床信息
技术以及伴随诊断等19个专题展开70余场的学术研讨。
特色专题
•
•
•
•
•
•
•
•
CFDA专题会场
促进NSCLC管理 —— 从精准医疗到个性化护理的启发
申办方与药品监管机构的良好沟通交流模式
通过多种快速审评机制加快新产品研发和上市
质量与合规的检查 —— 监查员的期望
医学事务的新职能转换 —— 首席医学官论坛
罕见病论坛
临床研究中的信息科技
迎接法规变革,聚力专业质量
2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
10
大会组织委员会
PROGRAM COMMITTEE
曹海峰 工商管理硕士
葛兰素史克政药政事务部负责人
曹莉莉
国家食品药品监督管理总局
中国食品药品国际交流中心
(CCFDIE)对外合作处处长
邓亚中 工商管理硕士
科文斯(中国)临床数据分析与
报告负责人
范帆 工商管理硕士
制药医学顾问
Haifeng CAO, MBA
Head of Regulatory Affairs, GSK
Lili CAO
Director, Division of External
Cooperation, CCFDIE, CFDA
Yazhong DENG, MBA
Head of Clinical Data Analysis
and Reporting Organization
(CDARO), Covance
Frank FAN, MD, MBA
Consultant on Pharmaceutical
Medicine
郭翔 博士
默沙东研发(中国)有限公司
生物统计总监
蒋燕敏
赛诺菲中国及亚太区研发中心
质量运营
李庆红 工商管理硕士
辉瑞(中国)研究开发有限公司
全球医学质量保证部总监, 亚洲
医学质量保证负责人
李艳 医学博士, 工商管理硕士
上海乔施商务咨询有限公司
全球负责人
Tony GUO, PhD
Director, Biostatistics,
MSD R&D (China) Co, Ltd.
Amy JIANG
Quality Operations,
China/AP R&D, Sanofi
Helen LI, MD, MBA
Asia Lead, PCO/DSU Audit, Pfizer
Medical Quality Assurance
Joy LI, MD, PhD, MBA
Global Head,
J&S (Shanghai) Co., Ltd.
李树婷
中国医学科学院肿瘤医院药物
临床研究中心GCP中心办公室
副主任,伦理委员会秘书
李媛
默沙东中国研发项目管理总监
梁冰
辉瑞全球安全及药政事务部
安全监测及风险管理 高级总监
林建莹
强生(中国)医疗器材有限公司
战略医学事务部副总裁
Shuting LI, MD
Vice Director, GCP Center,
the Cancer Hospital of Chinese
Academy of Medical Sciences
Yuan LI, MD
Director, Project Management,
MSD China R&D
Vera LIANG, MD
Senior Director, Disease Area
Cluster Leader Generics,
Shanghai Site Head,
Safety Surveillance and Risk
Management, Pfizer
Jane LIN, MD
Vice President, Strategic Medical
Affairs, Johnson & Johnson
Medical (China) Ltd.
蔺亚萌
罗氏(中国)投资有限公司
CMC政策法规资深经理
刘佳
爱恩希(北京)医疗科技技术有限
公司普药部亚太区副总裁
彭彬 医学/药理学博士
诺华中国生物医学研究有限公司
肿瘤转化医学部负责人
平文慧
上海切尔西医药科技咨询有限公
司首席执行官
Melly LIN
Senior Regulatory Manager,
CMC Policy,
Roche (China) Holding Ltd.
Jessica LIU, MD
Vice President,
Clinical Development,
General Medicine Business Unit,
Asia–Pacific Region, INC
Research
Bin PENG, MD, PhD
Global Head, Oncology
Translational Medicine China,
China Novartis Institutes for
BioMedical Research Co., Ltd.
Christina PING
CEO, Chelsea Clinical Research,
China
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
大会组织委员会
11
PROGRAM COMMITTEE
裘行敏
辉瑞公司全球安全及药政事务部
安全监测及风险管理总监
曲鹏 博士
辉瑞(中国)研究开发有限公司
统计部高级总监
孙华龙 医学博士
美达临床数据技术有限公司
总经理
王敏 医学博士
前葛兰素史克(上海)医药研发
有限公司药品研发副总裁
Xingmin QIU
Director, Safety Surveillance and
RiskManagement, Worldwide
Regulatoryand Safety, Pfizer
Roger QU, PhD
Head of Clinical Statistics,
Pfizer R&D Center
Hualong SUN, MD, PhD
General Manager,
Meta Clinical Technology
Min IRWIN, MD, PhD
Former Vice President, Medicines
Development, GlaxoSmithKline
王小玲
赛诺菲中国研发临床科学运营部
临床档案负责人
汪秀琴 博士
江苏省人民医院南京医科大学
第一附属医院伦理总监、伦理委
员会副主任委员、科技处副处长
许俊才
上海医药临床研究中心
高级副总裁/副主任
颜崇超 博士
江苏恒瑞医药股份有限公司
数据管理部高级总监
Xiaoling WANG
Head of Clinical Documentation,
Clinical Science Operation,
Sanofi R&D
Xiuqin WANG, PhD
Deputy Director, Department of
Science and Technology,
Jiangsu Province Hospital,
First Affiliated Hospital with
Nanjing Medical University
Jack XU, MD
Senior Vice President, Shanghai
Clinical Research Center
Charles YAN, PhD
Senior Director, Data
Management, Shanghai Hengrui
Medicine Co, Ltd.
闫水忠 医学博士
再鼎制药执行副总裁兼早期开发
及药物安全负责人
闫小军 工商管理硕士
百济神州高级副总裁及
药政事务部首席总监
张海洲 医学博士
上海中信国健药业股份有限公司
医学与转化中心执行副主任
张明平
PAREXEL Consulting产品研发
咨询部首席咨询员
James YAN, MD, PhD, DABT
Executive Vice President,
Head of Early Development and
Drug Safety, Zai Lab
Wendy YAN, MD, MBA
Senior Vice President,
Head of Regulatory Affairs,
BeiGene (Beijing) Co., Ltd.
Joe ZHANG, MD, PhD
Executive Deputy, Head of Center
of Medical and Translational
Sciences; Founder and Member,
R&D Committee, Group Leader,
R&D Working Group,
Shanghai CP GuoJian
Pharmaceutical Co. Ltd.
Mingping ZHANG
Principal Consultant, PAREXEL
Consulting
壁报评审委员会
POSTER REVIEW COMMITTEE
甄岭 法学博士, 工商管理硕士
昆泰企业管理(上海)有限公司
全球副总裁, 大中华区总经理
李继钢 工商管理硕士
西安杨森制药有限公司
医学事务总监
胥煜
北京科林利康医学技术服务中心
总经理
Ling ZHEN, JD, MBA
Vice President, Greater China,
Quintiles Enterprise Management
(Shanghai) Co. Ltd.
Jigang LI, MD, MBA
Director, Medical Affairs,
Xian-Janssen Pharmaceuticals
Ltd.
Yu XU
General Manager,
Beijing Clinical Service Center
J u n e 2 6 – 3 0 | P h i l a d e l P h i a , Pa
DIA 2016 is a global annual meeting to advance health
care product development around the world by connecting
stakeholders to interdisciplinary insights and innovation. It is our
largest event, packed with 175+ cross functional educational
offerings over 22 tracks on today’s hottest topics, bringing
together a global network of 7,000+ life sciences professionals
from industry, academia, regulatory and government agencies,
and patient and philanthropic organizations, to foster innovation
in the discovery, development and life cycle management of
health care products.
Keynote Speaker:
Larry Brilliant, MD, MPH
Acting Chairman of the Board, Skoll Global Threats Fund
Monday, June 27 | 2:30–4:00PM
Featured Sessions:
• Global Regulatory Harmonization in Asia: Is a New
Trend Occurring?
• Regulatory Changes in China and the Impact to Global Drug
Development Planning
• Conducting Trials in China
• Global Stakeholder Management: Across the Ocean Between
East and West
• Expedited Reviews and Other Pathways to Speed Up Access
to Medicines
Featured DIAmond Sessions:
Conversations on Today’s Priorities
• International Regulatory Convergence, Collaboration and Cooperation
• Value-Based Health Care Decision Making: The Quest for
Smarter Spending
• The Future of Big Data
• Next Generation Collaborations: Transforming the Industry
Register by
May 20 to Make
the Advance
Attendee List
#DIA2016
A g At h e r i n g o f g l o b A l p r o p o r t i o n s
Visit DIAglobal.org/DIA2016 for more information and to register.
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
DIA中国区顾问委员会 (2015–2017)
13
ADVISORY COUNCIL OF CHINA (ACC)
Overview
Chair
中国区顾问委员会(ACC)由企业、学术界、医疗机构和政府部门的专家
组成。委员会为DIA中国区开展学术交流活动、建立战略伙伴、发展会员等
提供战略指导和支持 。
The Advisory Council of China (ACC) consists of regional industry and
academic leaders, regulators and researchers who are responsible for creating
a sense of community among those who support the DIA vision to provide a
global forum for knowledge exchange that fosters innovation to raise the level
of health and well–being worldwide.
王劲松 医学博士
Atlas Venture公司
投资顾问
Jingsong WANG, MD, PhD
Advisor to Atlas Venture
Vice
Chair
中国区顾问委员会成员
Members of Advisory Council of China
Members
王劲松(主席)
Jingsong WANG (Chair)
吕玉真(副主席 )
Janet LV (Vice Chair)
曹莉莉
Lili CAO
曹晓春
Xiaochun CAO
陈小祥
Xiaoxiang CHEN
陈永涛
Bob CHEN
陈勇川
Yongchuan CHEN
陈之键
George CHEN
戴欣欣
Paul DAI
邓亚中
Yazhong DENG
冯欣毅
Yi FENG
郭欣翔
(Tony) Xiang GUO
黄欣钦
Qin HUANG
李庆红
Helen LI
李树婷
Shuting LI
李欣艳
Joy LI
梁欣冰
Vera LIANG
林建莹
Jane LIN
蔺亚萌
Melly LIN
刘晓曦
George LIU
牟欣骅
Hua MU
宁志强
Zhiqiang NING
宋瑞霖
Ruilin SONG
孙华龙
Hualong SUN
汪秀琴
Xiuqin WANG
王欣敏
Min WANG
夏结来
Jielai XIA
许俊才
Jack XU
张海洲
Joe ZHANG
张志民
Jimmy Z. ZHANG
甄欣岭
Ling ZHEN
朱向阳
Xiangyang ZHU
吕玉真
罗氏(中国)投资有限公司亚太区
法规部门负责人
Janet LV
Head of Regulatory, Asia Pacific,
Roche (China), Ltd.
Making Connections
建立联系
Fostering Relationships
增进了解
Advancing Innovation
推进创新
14
主旨讲演嘉宾 KEYNOTE SPEAKERS
王晓东 院士
百济神州创始人,科学顾问委员会主席
Xiaodong WANG, PhD
Founder & Chairman, Scientific Advisory Board, BeiGene
• 北京生命科学研究所(NIBS)所长和创始人
• 美国国家科学院院士,改革开放后留美学生进入美国最高科学殿堂第一人,2010年全
时回中国工作
• 中国科学院外籍院士
• 邵逸夫生物医学奖得主,“求是”杰出科学家
• 前霍华德休斯研究员,德克萨斯西南大学生物化学优秀讲席教授
• 前Joyant Pharmaceuticals美国肿瘤生物技术公司创始人
• 美国德克萨斯大学西南医学中心生物化学博士
•Founded BeiGene in 2010, and has served as Chairman of Scientific Advisory Board
since 2011
•Founding Director & Architect of 700-person team at the National Institute of Biological
Sciences (NIBS) in Beijing (2003-present)
•Howard Hughes Medical Institute Investigator, George L. MacGregor Distinguished Chair
in Biomedical Sciences (1997-2010) and Professor in Biomedical Sciences (2001-2010) at
University of Texas Southwestern Medical Center
•Member of National Academy of Sciences, USA
•Foreign associate of Chinese Academy of Sciences
•Founder of Joyant Pharmaceuticals, venture capital-backed oncology biotech in US
•Ph.D. in Biochemistry from University of Texas Southwestern Medical Center
•B.S. in Biology from Beijing Normal University
主旨讲演嘉宾 KEYNOTE SPEAKERS
15
Mark J. ALLES
美国新基公司首席执行官 / Chief Executive Officer, Celgene, USA
2016年全球生物医药界最具影响力人物 (FierceBiotech)
Mr. Alles serves as Celgene’s Chief Executive Officer. He assumed the role on March 1, 2016.
Previously he served as President and Chief Operating Officer. Mr. Alles served as Executive
Vice President and Global Head of Hematology and Oncology from December 2012 until
July 2014, following his promotion to Executive Vice President and Chief Commercial Officer
in February 2012. Mr. Alles joined Celgene in April 2004 and served as Vice President,
Global Marketing until March 2009 when he became President of the Americas Region.
Responsibility for commercial operations in Japan and the Asia Pacific Region was added
in July 2011. Mr. Alles previously served as Vice President for the U.S. Oncology Business
Unit of Aventis Pharmaceuticals and in other commercial sales and marketing management
roles over an 11-year period with Aventis. After earning his B.S. degree from Lock Haven
University of Pennsylvania and serving as a Captain in the United States Marine Corps,
Mr. Alles began his 29-year career in the pharmaceutical industry at Bayer and worked at
Centocor before its acquisition by Johnson & Johnson. Mr. Alles is a member of the Celgene
Board of Directors, the Trustees for the Healthcare Institute of New Jersey (HINJ), the
Board of the Biotechnology Innovation Organization (BIO), and the Board of Gilda’s Club
NYC, a not-for-profit organization helping the families of people living with cancer.
16
DIA 中国卓越服务奖 / DIA CHINA EXCELLENCE IN SERVICE AWARD
蔡伊志 博士
原DIA中国区办公室负责人
Jane CAI, PhD
Former Director of DIA China Office
蔡伊志博士,原药物信息协会(DIA)中国区总监;美国强生医药健康品企业研发部化学研究处高级
总监。
1990-1993年蔡伊志博士在美国Ciba-Geigy制药公司任高级研究员,从事原料药和化药的研发工
作。1993-2010,她在美国强生和强生(Johnson and Johnson)从事新药、仿制药、医疗器械及
健康保健品的研发、CMC、新药申报及技术转移等。在任职美国强生医药健康品企业研发部化学
研究处高级总监期间,她先后参与强生公司在美国和其它海外市场的产品开发研究工作及质量合
规稽查等多项项目管理。2010-2014年,她任DIA(药物信息协会)中国区负责人,为协会在中国建
立了跨学科领域的综合性药物信息学术交流平台。
在DIA中国工作期间,蔡伊志与DIA中国顾问委员会专家、来自中国和国际医药行业的志愿者及
DIA员工开展了近80项跨学科领域的学术交流研讨和培训教育活动. DIA中国与国内国际医药监管
机构、医药企业、学术院校、科技园区及学会协会等密切合作成功举办了多届DIA中国年会并为
中国药监部门、中国药学会及企业在DIA国际平台的交流与合作做出了努力和贡献。
蔡伊志毕业于美国纽约市立大学,拥有化学博士学位。
Jane Cai joined Ciba-Geigy Pharmaceutical as a senior scientist in 1990, working on new drug
development. From 1993-2010, she worked for Johnson & Johnson with responsibilities for new
drugs, generic drugs, medical devices, and healthcare products research and development,
regulatory submissions, quality compliance, and technology transfers. In 2010-2014, she led the DIA
China office to develop the DIA platform in China for knowledge exchange and information sharing.
During her DIA career, Jane and the DIA Advisory Council of China (ACC), volunteers from China
and global, and DIA staff developed and organized approximately 80 multidisciplinary workshops
and training programs. DIA China has also collaborated with China and global regulatory agencies,
pharmaceutical industry, academia, and associations, etc. and successfully organized several DIA
China Annual Meetings. Through the DIA platform, Jane has contributed to the collaborative
initiatives of the China regulatory agency, Chinese Pharmaceutical Association (CPA), and industries.
Jane graduated from City University of New York (CUNY), USA with a PhD degree in Chemistry.
DIA 中国卓越服务奖 / DIA CHINA EXCELLENCE IN SERVICE AWARD
17
曲鹏 博士
高级总监,辉瑞(中国)研究开发公司统计部负责人
Peng Roger QU, PhD
Senior Director and Head of Statistics Department
Pfizer China Research and Development Center
加入辉瑞中国之前,曲鹏博士先后在美国多家制药公司从事临床研究统计工作。在二十几年的职
业生涯中,他和他的统计团队在很多疾病领域为新药临床开发和法规注册提供统计支持。
加入辉瑞中国后,曲鹏博士不仅负责公司药物研发的统计工作,他还活跃在国内临床研究和统计
领域,多次担任药物信息协会年会组委会委员和定量科学论坛组委会委员,他是2010年至2014年
中国药物信息协会统计研讨班的联合主席,还兼任了2009年至2014年的培训课程的讲员,为中国
的临床统计和药物研发事业做出了许多努力和贡献。
曲鹏博士在美国威斯康辛大学麦迪逊分校获得统计学博士学位。
Prior to joining Pfizer China, Roger worked at different drug companies in US in clinical statistics to
support clinical development. During his 20 year industrial career, he led statistical teams supporting
clinical development and regulatory submission across a range of therapeutic areas.
Since joining Pfizer China, in additional to leading his team for statistical support to the company
clinical program, Roger was active in the local clinical and statistical communities. He was member
of program committee of DIA China Annual Meeting and Quantitative Science Forum for many years,
and organized statistical sessions each year. In addition, he was co-chair of DIA China Statistical
Workshop from 2010 to 2014, and was course instructor from 2009 to 2014. Roger made significant
effort in support of DIA China and advancement of clinical development in China.
18
DIA 中国卓越服务奖 / DIA CHINA EXCELLENCE IN SERVICE AWARD
许俊才
上海医药临床研究中心副主任; 上海杰医医药科技有限公司创始人
JACK XU
Senior Vice President, Shanghai Clinical Research Center
1992年7月 上海医科大学硕士毕业
1992年7月 – 1994年3月 中科院上海药物研究所药理研究
1994年 – 1997年 美国普强制药公司 医学经理
1997年 – 2000年 广州南新制药公司 医学注册部经理
2000年 – 2002年 荷兰上海劳登医药公司 医学总监
2002年 – 2005年 美国昆泰公司 医学总监
2005年 – 2007年 上海张江法玛勤公司 医学顾问
2008年 – 至今 上海医药临床研究中心 副主任
具有20余年丰富的国际药物研究经验。
Jack Xu is Senior VP, Shanghai Clinical Research Center. He is medical researcher with over 20
years experience in the management of Clinical Research programs and over 15 years knowledge
of the Chinese drug registration system. He got Master of Medicine in Occupational Health in 1992
and Bachelor of Preventive Medicine in 1987 respectively in Shanghai Medical University. The main
organizations of his working include: Researcher in Shanghai Institute of Materia Medica, Chinese
Academy of Science. CRA, Medical Manager, Clinical Research Manager in Upjohn & Pharmacia;
Manager of Regulatory and Medical Affairs in Ranbaxy; Medical Director in Loudon CRO; Director of
Clinical Operations in Quintiles; Medical Consultant in Zhangjiang Pharmaengine CRO; the founder
of Shanghai DrJ Medical Development Co. Ltd.
DIA 中国卓越服务奖 / DIA CHINA EXCELLENCE IN SERVICE AWARD
19
DIA’s Global
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Six
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迎接法规变革,聚力专业质量
2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
20
互动交流
NETWORKING
Refreshment Break
茶歇
5月15日 星期日 | 10:00–10:30, 15:00–15:30
三层,南序厅
5月16日 星期一 | 15:00–15:30
一层展厅,大宴A+B
5月17日 星期二 | 10:00–10:30, 15:00–15:30
一层展厅,大宴A+B
5月18日 星期三 | 10:00–10:30, 15:00–15:30
一层展厅,大宴A+B
午餐
Sunday, May 15
10:00–10:30, 15:00–15:30
3rd Floor, South Foyer
Monday, May 16
15:00–15:30
1st Floor, Ballroom A+B
Tuesday, May 17
10:00–10:30, 15:00–15:30
1st Floor, Ballroom A+B
1st Floor, Ballroom A+B
5月15日 星期日 | 12:00–13:30
三层,303A+B
Wednesday, May 18
10:00–10:30, 15:00–15:30
5月17日 星期二 | 12:00–13:30
一层餐区
大宴C及南大堂
Luncheon
5月18日 星期三 | 12:00–13:30
一层餐区
大宴C及南大堂
Sunday, May 15
12:00–13:30
3rd Floor, 303A+B
Tuesday, May 17
12:00–13:30
1st Floor, Ballroom C & South Lobby
Wednesday, May 18
12:00–13:30
1st Floor, Ballroom C & South Lobby
欢迎酒会
5月16日 星期一 | 17:30–19:00
一层展厅,大宴A+B
讲者/嘉宾招待酒会(仅限邀请)
5月17日 星期二 | 18:00–19:30
一层,多功能厅C厅
Opening Welcome Reception
Monday, May 16
17:30–19:00
1st Floor, Ballroom A+B
学术壁报展
5月16日 星期一 | 13:30–19:30
一层展厅,大宴A+B
Speaker & VIP Reception (by Invitation Only)
5月17-18日 星期二、三 | 08:30–17:30
一层展厅,大宴A+B
Tuesday, May 17
18:00-19:30
1st Floor, Function Hall C
颁奖典礼
DIA中国卓越服务奖
5月16日 星期一 | 13:30–17:30
Poster Presentation
四层,大会堂B
壁报颁奖活动
5月18日 星期三 | 10:00–10:30
一层展厅,大宴A+B
DIA微信关注领奖
Monday, May 16
13:30-19:30
1st Floor, Ballroom A+B
Tuesday & Wednesday,
May 17-18
08:30-17:30
1st Floor, Ballroom A+B
Award Ceremony
5月17-18日 星期二、三
DIA 展台
一层展厅,大宴A+B
DIA China Excellence in Service Award will be presented during the
opening plenary session.
Monday, May 16
13:30-17:30
展商印章收集开奖
5月18日 星期三 | 13:00
DIA 展台
一层展厅,大宴A+B
4th Floor, Plenary B
Award for Poster Presenters
Wednesday, May 18
10:00-10:30
1st Floor, Ballroom A+B
DIA全球年度标志性事件
欧洲年会 4月
中国年会 5月
欧洲罕见病和孤儿药大会 5月
北美年会 6月
中国药物创新会议 10月
日本年会 11月
Following DIA China WeChat
Wednesday, May 17-18
DIA Booth
1st Floor, Ballroom A+B
Stamp Rally
Wednesday, May 18
13:00
DIA Booth
1st Floor, Ballroom A+B
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
会议场地及住宿
21
VENUE AND HOTEL
主会场酒店
Main Venue Hotel
国家会议中心大酒店
China National Convention Center Grand Hotel
地址:北京朝阳区北辰西路8号院1号楼(鸟巢西北角)
联系人:陈思彤 女士
电话:(86 10) 8437 0690
传真:(86 10) 8437 0691
手机:15901256560
邮箱:[email protected]
网址:http://www.cnccgrandhotel.com/
Address: Building 1, No. 8 Precincts, Beichen West Road,
Chaoyang District, Beijing 100105
Contact person: Ms. Sitong Chen
Tel: +86 10 8437 0690 Fax: +86 10 8437 0691
Mobile: 15901256560
E-mail: [email protected]
Website: http://www.cnccgrandhotel.com/
其它推荐酒店
Other Recommended Hotels
北京北辰洲际酒店 (★★★★★)
地址:北京市朝阳区北辰西路8号院4号楼
联系人:于海燕 女士
传真:(86 10) 8437 1318
电话:(86 10) 8437 1305,1304
邮箱:[email protected]
网址:http://cn.ihg.com/intercontinental/peghc/hoteldetail
北京五洲大酒店 (★★★★)
地址:北京市朝阳区北辰东路8号
联系人:韩云涛 女士
电话:(86 10) 8498 5588
手机:13693305827
邮箱:[email protected]
网址:www.bcghotel.com
北京汇园酒店公寓贵宾楼 (★★★★★)
北辰汇园酒店公寓媒体村 (★★★★)
亚运村宾馆 (★★★)
地址:北京市朝阳区安定门外北辰东路8号
联系人:贾云云 女士
电话:(86 10) 6499 1166/3088/3099
传真:(86 10) 8497 0366
手机:13810336093
邮箱:[email protected]
网址:www.huiyuangongyu.com.cn
北京五洲皇冠国际酒店 (★★★★★)
地址:北京市朝阳区北四环中路8号 100101
电话:(86 10) 6481 7136/7137/7138/7141/7142
传真:(86 10) 6499 3180
邮箱:[email protected]
网址:www.v-continent.com
北京红杉假日酒店 (★★★★)
地址:中国北京市海淀区双清路89号A座 邮编:100085
联系人:史佳 先生
电话:(86 10) 8239 8888/400 88 40 888
传真:(86 10) 8239 1688
手机:15910459772
邮箱:[email protected][email protected]
网址:www.holidayinn.com.cn
InterContinental Beijing Beichen (★★★★★)
Address: No. 8, Beichen West Road, Chaoyang District,
Beijing 100105
Contact person: Ms. Amy Yu
Tel: +86 10 8437 1188 Fax: +86 10 8437 1318
Mobile: 13511008203
Beijing Continental Grand Hotel (★★★★)
Address: No. 8, Beichen East Road, Chaoyang Distrct,
Beijing, 100101, P. R. China
Contact person: Ms. Yuntao Han
Tel: +86 10 8498 5588 Mobile: 13693305827
Email: [email protected]
Website: www.bcghotel.com
Beijing North Star Huiyuan Service Apartments
(★★★★★/★★★★/★★★)
Address: No. 8, North Star East Road, Andingmen, Chaoyang
Distrct, Beijing, 100101
contact: Ms. Suki Jia
Mobile: 13810336093
Tel: +86 10 6499 1166/3088/3099 Fax: +86 10 8497 0366
Email: [email protected]
Website: www.huiyuangongyu.com.cn
V-Continent Beijing Parkview Wuzhou Hotel (★★★★★)
Address: No. 8, North Si Huan Zhong Road, Chaoyang Distrct,
Beijing, 100101
Tel: (86 10) 6481 7136/7137/7138/7141/7142
Fax: (86 10) 6499 3180
Email: [email protected]
Website: www.v-continent.com
Holiday Inn Beijing Haidian (★★★★)
Address: Building A, No. 89 Shuangqing Road, Haidian District
Beijing 100085
Contact person: Mr. Michael Shi Mobile: 15910459772
Tel: +86 10 8239 8888/400 88 40 888
Fax: +86 10 8239 1688
Email: [email protected] or
[email protected]
Website: www.holidayinn.com.cn
迎接法规变革,聚力专业质量
2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
22
北京介绍
ABOUT BEIJING
北京国家会议中心 | China National Convention Center (CNCC)
2008年8月8日,举世瞩目的奥运会在北京举行。坐落在北京
奥林匹克公园中心区内,紧邻鸟巢和水立方的国家会议中心也
成为世界的焦点。国家会议中心作为主新闻中心、国际广播中
心,还是奥运会的击剑比赛以及现代五项的击剑和气手枪比赛
的场馆。残奥会结束后,国家会议中心进行了内部改造,于
2009年11月盛大开幕。
国家会议中心总占地面积12公顷,总建筑面积53万平方米,建
筑南北长400米,东西宽150米,檐高40米。其中会议、展览
面积27万平方米,配套项目建筑面积26万平方米(包括两家酒
店、两栋写字楼),是目前亚洲最大的会议中心。
China National Convention Center (CNCC) has opened officially
in October 2009 for its originally intended function – providing
international standard, purpose-built convention and exhibition
facilities.
The Center was an important element in the overall plan for the
2008 Beijing Olympic Games when it served as the main press
center and international broadcasting location as well as providing
the venue for fencing and pistol shooting competitions.CNCC is
ideally located in the heart of the Olympic Green adjacent to the
National Stadium (Bird’s Nest), the National Aquatics Center
(Water Cube) and the National Indoor Stadium – all of which
are proving popular places for people to visit in post-Olympic
Games times.
After the Olympic Games, CNCC took some renovations
and opened officially in Nov.2009. Now CNCC is the
largest convention center in Asia for hosting congresses,
international meetings, exhibitions and other various events,
with the world-class services and unparalleled facilities provided.
北京国家体育场 | Beijing National Stadium (BNS)
北京国家体育场,由于独特造型也称“鸟巢”,长330米,宽220
米,高度为69.2米,占地25万平方米。运用高达4.5万吨钢建成
的体育馆,建筑费用高达人民币35亿元。此馆于2004年3月正
式开工,2008年6月28日完工,是2008年北京夏季奥运会和残
奥会主场馆。2008年奥运会之后,这里举办了很多足球与其它
赛事。2022年的冬奥会和残奥会也将重用。体育场在奥运会期
间设有10万个座位,承办该届奥运会的开闭幕式、田径和足球
等比赛项目。奥运会后座位数将减至8万个。精彩绝伦的开闭
幕式表演与鸟巢大气宏伟的结构相得益彰,令世人惊艳。博尔
特、伊辛巴耶娃等一批优秀运动员纷纷在鸟巢实现了创纪录竞
技。
距离国家会议中心2.2公里,步行约30分钟。地铁8号线在国家
体育场设有停靠站。
Beijing National Stadium (BNS) in Beijing, known as the Bird’s
Nest, was designed for use throughout the 2008 Summer
Olympics and Paralympics and will be used again in the 2022
Winter Olympics and Paralympics. The stadium is currently used
mostly for football matches. Ground was broken on 24 December
2003 and the stadium officially opened on 28 June 2008. The
Bird’s Nest once had 100,000 seats during the 2008 Olympics
and now remains 80,000 seats after Olympics. A shopping mall
and a hotel are planned to be constructed to increase use of
the stadium, which has had trouble attracting events, football
and otherwise, after the Olympics. This will become the most
important public space in Beijing.
2.2km, 30mins walk from China National Convention Center
(Venue). Beijing Subway Line 8 has stop for Beijing National
Stadium.
奥林匹克森林公园 | Beijing Olympic Forest Park
奥林匹克森林公园位于北京中轴延长线的最北端,是亚洲最大
的城市绿化景观,占地约680公顷,是一个比圆明园和颐和园加
在一起都要大的公园。于2003年开始建设,2008年7月3日正式
落成。北五环路横穿公园中部,将公园分为南北两园,中间有
一座横跨五环路、种满植物的生态桥连接。奥森公园以山体、
林地、湖泊、湿地等自然景观成为城市中的绿色生态园林,被
称之为北京的“肺”。它是北京奥运建成品中美轮美奂的一颗
翡翠,是“科技奥运,人文奥运,绿色奥运”精神的延伸。
地铁8号线在奥林匹克森林公园设有站点。如从国家会议中心步
行至奥森公园南门,距离国家会议中心1.84公里,约20-30分
钟。
Beijing Olympic Forest Park is the key project of Beijing 2008
Olympic Games, located in the most northern tip of Central
Axis of Beijing, is Asia’s largest urban greening landscape,
covering about 680 hectares, and is larger than the total area
of the Summer Palace and the Old Summer Palace. It began
to construct in 2003 and formally completed on July 3, 2008.
Across the middle of the north fifth ring road, the central park,
is divided into the north and the south park, connected by an
eco-bridge full of plants. The Forest Park with mountains, forest,
lakes, wetland and other natural landscapes as its main part
has become the green park and called the “lung” of the Beijing
city. It is an extension of the spirit of “Hi-tech Olympics, Cultural
Olympics and Green Olympics” and becomes an emerald of all
the finished Olympic buildings in Beijing. Tourists can visit water
cube by taking Beijing Subway Line 8. 1.4km, 20mins walk from
China National Convention Center (Venue).
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
北京介绍
23
ABOUT BEIJING
国家游泳中心(水立方) | Water Cube
国家游泳中心(水立方)位于北京奥林匹克公园内,2008年北
京奥运会标志性建筑物之一,总建筑面积约10万平方米,于
2003年12月24日开工,于2008年1月竣工。
2008年奥运会期间,国家游泳中心承担游泳、跳水、花样游泳
等比赛,产生42块奥运金牌。奥运会后,具有国际级设施水平
和知名度的游泳中心既可承担重大水上比赛(如:残奥会、世
界游泳、跳水锦标赛)和各类常规赛事,同时也是具有国际先
进水平的、集游泳、运动、健身、休闲于一体的多功能国际化
时尚中心,为市民强身健体提供良好的基础条件。
乘坐地铁8号线可到达水立方。如从国家会议中心步行,距离国
家会议中心1.4公里,约20分钟。
The National Aquatics Center, better known as “Water Cube”,
is one of the best venues of the 2008 Beijing Olympics. It was
chosen through public appraisals as one of “China ten big new
architecture views” by The U.S. magazine “Business Weekly”.
The iridescent bubble wrapped rectangular box shaped structure
won the 2011 National Science & Technology Progress Award,
First Class, for its deliberate morphing of molecular science,
architecture and phenomenology that can create an airy and
misty atmosphere for a personal experience of water leisure.
The venue hosted the swimming, diving and synchronized
swimming events during the Olympics, when it saw 21 world
records tumbling down for 24 times. For this, it has been reputed
as a “magic water cube” and an “Aquatic Hall of Fame”. The
comprehensive utilization and diversified development of the
post-Olympic venue includes hosting international and domestic
competition events, setting up a swimming club to promote
popular swimming, offering the venue as a resident performing
arts theater to cultivate famous brands, holding large-scaled
painting and calligraphy exhibitions and marketing Olympic
licensed products.
The Water Cube Series of licensed products have been rated
among the “Top 10 Musts for Tourists to Beijing”. Tourists can
visit water cube by taking Beijing Subway Line 8. 1.4km, 20mins
walk from China National Convention Center (Venue).
王府井商业街 | Wangfujing
王府井商业街坐落于北京市东城区,是北京著名的商业步行
街。它的历史可以追溯到13世纪,1267年元代初年,至今已经
有700多年了。从它的名字来说,一开始叫丁字街,后来叫十王
府街、王府街。到1905年,因为王府井大街开凿了一眼甘甜的
水井,所以从1905年开始叫做王府井大街。
如今的王府井汇集了包括盛锡福帽店、同升和鞋店、吴裕泰茶
庄等众多老字号在内的280多家北京知名商户。曾经为第一代新
中国领导人照相的中国照相馆和由宋庆龄女士一手建立的新中
国妇女儿童商店也坐落在此。
王府井小吃街位于主干道西侧的胡同里,聚集了大小餐馆和路
边小吃摊,经营各类小吃与食品。 “串儿” 是这里最受欢迎
的小吃,还有最具老北京特色的糖葫芦、糖豆儿等。
王府井距离国家会议中心约14.5公里,乘坐北京地铁1、5号线
可到达王府井。
Wangfujing is one of the most famous shopping streets of Beijing,
located in Dongcheng District, and has over 700 years since early
Yuan Dynasty. The majority of the main area is pedestrianised
and very popular shopping place for both tourists and residents
of the capital. Its initial name was Dingzi Street, then people
called it Shiwangfu Street or Wangfu Street. In 1905, people
found a well with cool and crystalline water. Therefore, it had a
new name Wangfujing which has been remained till today.
Wangfujing is now home to around 280 famous Beijing brands,
such as Shengxifu hat store, Tongshenghe shoe shop, and the
Wuyutai tea house. A photo studio which took formal photos of
the first Chinese leadership, the New China Woman and Children
Department Store helped established by Soong Ching-ling
(Madame Sun Yat-sen) are also located on the street.
The Wangfujing snack street, located in hutongs just west of the
main street, is densely packed with restaurants and street food
stalls. The food stalls serves a wide variety of common and exotic
street food. More common fare such as chuanr (meat kebabs,
commonly made of lamb) and desserts, such as tanghulu or
candied fruits on a stick, are among the most popular.
Wangfujing is around 14.5km away from China National
Convention Center. Tourists can take Beijing Subway Line 1. The
Wangfujing Station of Beijing Subway Line 1 is located at the
intersection of Wangfujing Street and Chang’an Avenue.
迎接法规变革,聚力专业质量
2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
24
北京介绍
ABOUT BEIJING
正阳门俗称前门 | Qianmen
正阳门俗称前门,位于天安门广场南侧,是北京极具历史意义
的一个城门,也是北京城地标式建筑。前门大街,明、清至民
国时皆称正阳门大街,民众俗称前门大街,位于京城中轴线,
北起前门月亮湾,南至天桥路口,与天桥南大街相连,自古就
是御道天街的黄金地段,现在是北京著名商业街。
前门大街汇集了众多知名老字号餐馆和各类商铺:全聚德烤鸭
店、便宜坊烤鸭店、瑞蚨祥绸布店、同仁堂药铺、六必居酱菜
园等。1979年以后,在原有老字号商店和传统经营特色基本保
留下来的同时,又陆续开设了五金交电、服装百货、自行车、
食品、钟表、化工油漆等新店。
乘坐地铁2号线至前门站可到达前门
大街。
Qianmen is the colloquial name for Zhengyangmen, a gate in
Beijing’s historic city wall. The gate is situated to the south of
Tiananmen Square and remains an important geographical
marker of the city. The Beijing central north-south axis passes
through Zhengyangmen’s main gate. Qianmen Street is in the
middle of the axis, north from the Front Door Moon Bay and
south to Tianqiao road intersection, connected with the Tianqiao
South Street. Since built up from the Ming Dynasty five hundreds
year ago, it was the imperial road only for emperors from the
Forbidden City outside to the city and now it becomes one of the
most famous commercial streets in Beijing.
Qianmen Street gathers many time-honored restaurants and
shops: Quanjude Roasted Duck, Bianyifang Roasted Duck,
Ruifuxiang Mercery, Tongrentang Pharmacy, Liubiju Pickles,
etc. Since 1979, more diversified shops, including, hardware
stores, clothing shops, bicycles, food, watches, chemicals
and painting store, open in Qianmen Street.
There is about 18km distance between China National
Convention Center and Qianmen Street. Subway is the best
means of transportation to get Qianmen. Qianmen Station of
Subway Line 2 is located between the two structures inside the
space once surrounded by the barbican.
南锣鼓巷 | Nan Luogu Xiang (Gong lane)
南锣鼓巷是北京市东城区一条长约800米的胡同,也是北京最
古老的街区之一,也位列规划中的25片旧城保护区之中。南锣
鼓巷始建于元代,从清代约1750年左右开始,一直沿用此名。
近几年,因为汇集了众多四合院、特色中西餐馆、陶艺馆以及
古董店等而成为旅游热点。
许多时尚杂志报道的热点,不少电视剧在这里取景拍摄,许多
国外旅行者把其列为在北京的必游景点。其实,明清以来,这
里一直是“富人区”,居住过许多达官贵人、社会名流,从明
朝将军到清朝王爷,从北洋政府总统到国民党总裁,从文学大
师到画坛巨匠,这里的每一条胡同都留下历史的痕迹。
6号线南锣鼓巷地铁站位于胡同南口,并于2012年开放。
Nan Luogu Xiang (Gong lane) is known as a hutong with wellpreserved traditional architecture in an 800-meter length. It’s one
of the oldest neighborhoods in Beijing and the top 25 pieces in
Beijing ancient urban protection planning. It was built in the Yuan
Dynasty and received its current name during the Qing Dynasty
around 1750. In recent years, the area’s hutong has become a
popular tourist destination due to the features of siheyuan,
Chinese restaurants, ceramics, and antique shops. Since Ming and
Qing Dynasties, it has become “rich people’s region”, many elites,
magnates and nobles, from President of Beiyang Government to
the KuoMinTang President, from literature masters to celebrities,
every lane leaves the traces of history.
There is about 18km distance between China National Convention
Center and Qianmen Street. Subway is the best means of
transportation to get Qianmen. Qianmen Station of Subway Line
2 is located between the two structures inside the space once
surrounded by the barbican.
Nanluoguxiang Station of Beijing Subway Line 6 and Line 8
opened in 2012 and is located near the south entrance of the
hutong. Tourists are suggested to take Line 8 to Nanluoguxiang
directly, 8.5km away from China National Convention Center.
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
国家会议中心大酒店 –
China National Convention Center Grand Hotel
北京北辰洲际酒店 – InterContinental Beijing Beichen
25
北京五洲大酒店 – Beijing Continental Grand Hotel
北京汇园酒店公寓贵宾楼 –
Beijing North Star Huiyuan Service Apartments
媒体合作伙伴
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Www.Druggcp.Net
环球医学资讯
活动家
huodongjia.com
MEDIA PARTNERS
56
QUICK GUIDE TO THE PROGRAM
SUNDAY, MAY 15, 2016 | PRECONFERENCE WORKSHOP
07:30 – 17:30
1st Floor
Registration Open
13:30 – 17:30
3rd Floor, 301A
Workshop 1
Demystifying Regulatory Inspections in China
08:30 – 17:00
3rd Floor, 301B
Workshop 2
Medical Coding
3rd Floor, 302A
Workshop 3
Strategy and Key Considerations for Simultaneous Filing of Innovative Drugs in
China and Abroad
3rd Floor, 302B
Workshop 4
CDISC Standards for Clinical Trial
10:00 – 10:30
3rd Floor, South Foyer
Refreshment Break
12:00 – 13:30
3rd Floor, 303A+B
Luncheon
15:00 – 15:30
3rd Floor, South Foyer
Refreshment Break
MONDAY, MAY 16, 2016 | CONFERENCE DAY 1
08:30 – 17:30
1st Floor
Registration Open
13:30 – 17:30
4th Floor, Plenary Hall B
Opening Plenary Session + Special Forum
15:00 – 15:30
1st Floor, Ballroom A+B
Refreshment Break
17:30 – 19:00
1st Floor, Ballroom A+B
Opening Welcome Reception
TUESDAY, MAY 17, 2016 | CONFERENCE DAY 2
07:30 – 17:30
1st Floor
Registration, Exhibition and Poster Session Open
08:30 – 10:00
3rd Floor, 311A
Session 0101
Enhancement for Post-Marketing Commitment Clinical Trials to Realize Accelerated
Approvals
3rd Floor, 311B
Session 0301
Advancement of NSCLC Management - Implication of Precision Medicine to
Personalized Care
3rd Floor, 310
Session 0401
CFDA Inspection: Whether a Bright Sunny Sky Will Appear After Haze Swept Off?
3rd Floor, 303A
Session 0601
Bridge the Real World to the Clinical Development - Part 1
3rd Floor, 302A
Session 0701
Bundling Review and Approval of Packaging Components and Pharmaceutical
Excipients
3rd Floor, 303B
Session 0801
Recent Trends in the Regulation of Biopharmaceutical Products
3rd Floor, 306B
Session 0901
How to Improve the Ethics Review Quality
3rd Floor, 301B
Session 1001
Innovation and Initiatives of Pharmacovigilance Operation in China
3rd Floor, 301A
Session 1201
Medical Affairs Strategic Transformation in the New Era
3rd Floor, 305
Session 1301
Rare Diseases Part 1:The Concept of Rare Diseases
3rd Floor, 302B
Session 1601
Challenges and Opportunities in the New Regulatory and Innovation Environment
- Part 1
3rd Floor, 308
Session 1901
Clinical Trial in Mobile Internet Era: Model Optimization and Efficiency Improvement
10:00 – 10:30
1st Floor, Ballroom A+B
10:30 – 12:00
3rd Floor, 311A
Session 0102
eCTD: Implementation and Preparation
3rd Floor, 311B
Session 0302
Breakthrough of Drug Development and Patient Management in Key Respiratory
3rd Floor, 310
Session 0402
Risk Based Quality Control: How to Have a Good Cooperation
between CRA and CRC
3rd Floor, 303A
Session 0602
Bridge the Real World to the Clinical Development - Part 2
3rd Floor, 302A
Session 0702
International Registration of Generic Drug
3rd Floor, 303B
Session 0802
Development of Biosimilars: Technical Aspects
3rd Floor, 306B
Session 0902
Inspections on Quality and Compliance – What Are Inspectors’ Expectations
3rd Floor, 301B
Session 1002
Pharmacovigilance in a New Era – Hot Topics
3rd Floor, 301A
Session 1202
Post-Marketing Studies in the New Era of Precision Medicine
3rd Floor, 305
Session 1302
Rare Diseases Part 2: The Practice of Rare Diseases
3rd Floor, 302B
Session 1602
Challenges and Opportunities in the New Regulatory and Innovation Environment
- Part 2
3rd Floor, 308
Session 1902
The Path Forward of Future Clinical Trials
Refreshment Break
12:00 – 13:30
1st Floor, Ballroom C & South Lobby
Luncheon
13:30 – 15:00
3rd Floor, 309A+B | 311 A+B
China Food and Drug Administration (CFDA) Town Hall - Part 1
3rd Floor, 302A
Session 0703
Life-Cycle Management of Biological Products
3rd Floor, 301B
Session 1003
Data-Driven Decision Making
3rd Floor, 302B
Session 1603
Challenges and Opportunities in the New Regulatory and Innovation Environment
- Part 3
3rd Floor, 301A
Session 1803
Molecular Information Towards New Era of Precision Medicine - Part 1
15:00 – 15:30
1st Floor, Ballroom A+B
15:30 – 17:30
3rd Floor, 309A+B | 311 A+B
China Food and Drug Administration (CFDA) Town Hall - Part 2
3rd Floor, 302A
Session 0704
Quality Consistency of Generic Drug
3rd Floor, 301B
Session 1004
Effective and Timely Risk Communication
3rd Floor, 301A
Session 1804
Molecular Information Towards New Era of Precision Medicine - Part 2
18:00 – 19:30
1st Floor, Function Hall C
Refreshment Break
Speaker & VIP Reception (by Invitation Only)
57
QUICK GUIDE TO THE PROGRAM
WEDNESDAY, MAY 18, 2016 | CONFERENCE DAY 3
07:30 – 17:30
1st Floor
Registration, Exhibition and Poster Session Open
08:30 – 10:00
3rd Floor, 311A
Session 0105
Best Practice for Communication between Sponsors and Health Authorities
3rd Floor, 311B
Session 0305
The Clinical Research of New Vaccines
3rd Floor, 310
Session 0505
To be Operational Excellence in Clinical Trial - Part 1
3rd Floor, 303A
Session 0605
Data Quality and Integrity - Part 1 Clinical Trial Data Management and Collaborated
Quality Control
3rd Floor, 302A
Session 0705
Role of Public Standard in the Drug Registration - Part 1
3rd Floor, 303B
Session 0805
Clinical Trial Design of Biosimilar - Part 1
3rd Floor, 306B
Session 0905
Transform Quality Science from Reactive to Proactive
3rd Floor, 306A
Session 1105
Inheriting and Innovation: How Medical Writers Working in Global Pharmaceutical
Companies Support Regulatory Requirements from Different Authorities
3rd Floor, 301A
Session 1205
The Roles and Working Models of Field Medical Science Liaisons in China
3rd Floor, 301B
Session 1405
Ready for the Big World? – How Can Chinese Pharmaceutical Companies Leverage
CRO to Grow Bigger and Faster?
3rd Floor, 302B
Session 1705
Non-Clinical Safety Assessment in the New Drug Development
3rd Floor, 308
Session 1905
Value of Pharmacometric Analyses in Drug Development
10:00 – 10:30
1st Floor, Ballroom A+B
10:30 – 12:00
3rd Floor, 311A
Session 0106
Expedited Pathway to Facilitate Drug Development
3rd Floor, 311B
Session 0306
Breakthrough of Hepatitis Treatment in China
3rd Floor, 310
Session 0506
To be Operational Excellence in Clinical Trial - Part 2
3rd Floor, 303A
Session 0606
Data Quality and Integrity - Part 2 Global Data Integrity vs. CFDA
Data Self-Assessment
3rd Floor, 302A
Session 0706
Role of Public Standard in the Drug Registration - Part 2
3rd Floor, 303B
Session 0806
Clinical Trial Design of Biosimilar - Part 2
3rd Floor, 306A
Session 1106
How Does Medical Writing Support China Local Company on Drug
Registration Abroad
3rd Floor, 301A
Session 1206
The Working Model of Medical and Commercial Functions in the PatientCentric Healthcare Environment
3rd Floor, 301B
Session 1406
Time for an Upgrade – Evolving Cooperation Model between CROs and
Pharmaceutical Companies
3rd Floor, 306B
Session 1506
Information Technology in Clinical Studies: Regulatory Requirement
3rd Floor, 302B
Session 1706
Pharmacometrics and Mechanism- Based PK/PD Modeling in Early Drug
Development
3rd Floor, 308
Session 1906-1
Drive Global Innovation with an Integrated Drug Development Strategy
3rd Floor, 305
Session 1906-2
Australia: A Premier Destination for Early Stage Clinical Trials
Refreshment Break
12:00 – 13:30
1st Floor, Ballroom C & South Lobby
Luncheon
13:30 – 15:00
3rd Floor, 311A
Session 0107
How to Establish Proper IND Framework in China - Part 1: Filing and Review
Process and Dossier Requirement
3rd Floor, 311B
Session 0307
Innovative Medicines in Cardiovascular and Metabolic Field Made Huge Impact on
Cardiovascular Treatment
3rd Floor, 310
Session 0507
To be Operational Excellence in Clinical Trial - Part 3
3rd Floor, 303A
Session 0607-1
Global Requirements of Submission Data Standards: Past, Current and Future
3rd Floor, 305
Session 0607-2
Pharmaceutical Biostatistics Group Operating Models in China - What the
Multinational Pharma Companies Have Learned in the Last Seven Years
3rd Floor, 302A
Session 0707
BE Study of Generic Drug
3rd Floor, 303B
Session 0807
Naming and Pharmacovigilance for Biologics
3rd Floor, 306A
Session 1107
Risk-Based Project Management
3rd Floor, 301A
Session 1207
Medical Communication: Opportunities under the “New Normal”
3rd Floor, 301B
Session 1407
A Journey without Detour – Data Quality Matters
3rd Floor, 306B
Session 1507
The Application of Information Technology in Clinical Trials
3rd Floor, 302B
Session 1707
Biomarkers and Translation Medicine
3rd Floor, 308
Session 1907
Pharmacovigilance – Customized Safety Database for Chinese Regulations
15:00 – 15:30
1st Floor, Ballroom A+B
15:30 – 17:30
3rd Floor, 311A
Session 0108
How to Establish Proper IND Framework in China - Part 2: Supporting System
3rd Floor, 303A
Session 0608
Nurturing Statistical Mindset in Data Management for Quality Improvement
3rd Floor, 302A
Session 0708
Biowaiver: In-vitro Dissolution
3rd Floor, 303B
Session 0808
Cutting Edge Technologies in Biologics Development
3rd Floor, 306A
Session 1108
Project Risk Management: Dealing with the Certainty of the Uncertainty
3rd Floor, 301A
Session 1208
HEOR & Market Access
3rd Floor, 301B
Session 1408
SMO/CRC – A Bridge over the Troubled Water
3rd Floor, 306B
Session 1508
Information Technology in Clinical Studies
3rd Floor, 302B
Session 1708
Early Clinical Development
Refreshment Break
迎接法规变革,聚力专业质量
2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
58
SUNDAY, 15 MAY | PRCONFERENCE WORKSHOPS
Workshop 1 (Half Day)
13:30–17:30
3rd Fl, 301A
Demystifying Regulatory Inspections in China
Workshop 2 (Full Day)
08:30–17:00
3rd Fl, 301B
Medical Coding
Workshop 3 (Full Day)
08:30–17:00
3rd Fl, 302A Strategy and Key Considerations for Simultaneous Filing of Innovative Drugs in
China and Abroad
Workshop 4 (Full Day)
08:30–17:00
3rd Fl, 302B CDISC Standards for Clinical Trial
SUNDAY, 15 MAY
Workshop
1
13:30 – 17:30 | 3rd Floor, 301A
Demystifying Regulatory
Inspections in China
Given that China is slated to become the world’s largest
pharmaceutical market, the number of both domestic and global
clinical trials conducted in China has been growing exponentially
over the years. Although foreign inspections by FDA, PMDA
and EMA are increasing in China, they are still relatively few in
numbers and the majority of researchers participating in global
trials have not experienced it.
The recent mandate by CFDA for NDA applicants to perform selfinspections and the unannounced on-site inspections conducted
by CFDA in recent months calls for the need to demystify
inspections in China, how to be ready for any inspections,
how to interpret the GCP non-compliances and distinguish the
significance of these non-compliances so as to stay on top of the
current changes and the associated challenges in the dynamic
and complex world of clinical research in China focusing on the
common critical issues surrounding data integrity.
The workshop will invite leading experts from the industry,
Chinese hospital GCP Office, clinical trial investigator and
government official to share their views and insights to the key
topic related to inspection conducted by various agencies
LEARNING OBJECTIVES
•Understand the different types of inspections in China, their
objectives and processes by the different authorities
•Have an overview of the common GCP findings in these
inspections in China and in particular how to interpret and
rate these findings in relation to what constitutes data
integrity.
•Be able to differentiate the findings from the CFDA on-site
inspections that are likely to influence data authenticity and
reliability
TARGET AUDIENCES
•Senior Executives
•Regulatory Affairs Professionals
•Clinical Research and Development (Clinical Operations,
Clinical Assurance, Compliance, Auditors, Consultants)
•Site Investigators
•Chinese Hospital GCP Office Officers
•Regulatory Inspectors
PROGRAM COMMITTEE
Ellyne SETIAWAN
Head of Quality Medicine, ROPU-TCM, Boehringer Ingelheim
Shuting LI, MD
Vice Director, GCP Center, the Cancer Hospital of Chinese
Academy of Medical Sciences
Xiuqin WANG, PhD
Deputy Director, Department of Science and Technology,
Jiangsu Province Hospital, First Affiliated Hospital with Nanjing
Medical University
Liping ZHOU
Global Inspection Manager, Inspection Management
Bayer R&D Quality
Peter SCHIEMANN, PhD
Managing Partner, Widler & Schiemann Ltd., Swizerland
AGENDA
13:30 - 13:40 Opening & Welcome
Ellyne SETIAWAN
Head of Quality Medicine, ROPU-TCM, Boehringer Ingelheim
13:40 - 14:20 GCP Inspections in Shanghai: Observed Practice
from Various Authorities
Liping ZHOU
Global Inspection Manager, Inspection Management
Bayer R&D Quality
14: 20 - 15:00 The Common GCP Findings in These Inspections
and in Particular How to Interpret and Rate
These Findings in Particular Relation to What
Constitutes Data Integrity
Peter SCHIEMANN, PhD
Managing Partner, Widler & Schiemann Ltd., Swizerland
15:00 - 15:30 Tea Break
15:30 - 16:10
An Introduction and An Overview to the Key
Findings in the Recent CFDA On-Site Inspections
since the Implementation of the Self-Check by
CFDA
Xiuqin WANG, PhD
Deputy Director, Department of Science and Technology,
Jiangsu Province Hospital, First Affiliated Hospital with Nanjing
Medical University
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
16:10 - 17:10
Panel Discussion
Above Speakers and Invited Panelists
Shuting Li
Vice Director, GCP Center, the Cancer Hospital of Chinese
Academy of Medical Sciences
Xiaoxiang CHEN, MD
Vice President, Medicine Development, Greater China,
Boehringer Ingelheim, Germany
17: 10
Closing Remarks
Ellyne SETIAWAN
Head of Quality Medicine, ROPU-TCM, Boehringer Ingelheim
•CRA
•CRC
•Clinician
•Statistician
•SAS programmer
•Drug Safety
•Project Manager
PROGRAM CHAIR
Charles YAN, PhD
Senior Director, Data Management,
Shanghai Hengrui Medicine Co, Ltd.
KEY INSTRUCTORS
SUNDAY, 15 MAY
Workshop
2
08:30–17:00 | 3rd Floor, 301B
Medical Coding
In the late 1990s, ICH developed MedDRA as a rich and highly
specific standardized medical terminology to facilitate sharing
of regulatory information internationally for medical products
used by humans. Products covered by the scope of MedDRA
include pharmaceuticals, biologics, vaccines and drug-device
combination products. Today, MedDRA is growing used
worldwide by regulatory authorities, pharmaceutical companies,
clinical research organizations and health care professionals
allows better global protection of patient health.
The WHO Drug Dictionary is an international classification of
medicines created by the WHO Programme for International
Drug Monitoring and managed by the Uppsala Monitoring Centre.
It is used worldwide by pharmaceutical companies, clinical trial
organizations and drug regulatory authorities for identifying drug
names in spontaneous ADR reporting (and Pharmacovigilance)
and in clinical trials.
This pre-conference workshop will introduce MedDRA and WHO
DD in their basic concept, scope, structures and coding rules. It
will provide coding skill training with examples and classroom
excises. The coding tools will be covered too.
LEARNING OBJECTIVES
•To introduce the basic definitions and concepts that
characterize MedDRA
•To demonstrate how MedDRA is used by pharmaceuticals,
regulatory authorities and by contract research organizations.
•To present an overview of some of the aspects of MedDRA
terminology that affect case assessment, safety surveillance,
labeling, and regulatory reporting.
•To provide rules for the coding of medical data (drug safety
and data management) and by using these rules, the coding
of medical data will achieve a higher level of consistency and
accuracy.
•Provide insights to challenges you may face when you retrieve
and report data coded in MedDRA.
•Provide insights to challenges you may face when you retrieve
and report data coded in MedDRA.
TARGETED AUDIENCES
•Medical Coder
•Data Manager
Yuxiu LIU
Professor, Director of Department of Medical Statistics,
Nanjing General Hospital of Nanjing Military Region
Xiaofei YE, MD, PhD
2nd Military Medical University
Pansie ZHANG
Senior Specialist, Clinical Data Management, MSD
Dejuan DUAN
Clinical Data Manager, MSD
Tao GAO
Clinical Data Manager, Covance
Liyang LIU
Clinical Data Coordinator, Covance
Ellene CARIN
Senior Coding Specialist, WHO Drug Production
Uppsala Monitoring Centre
AGENDA
8:30 - 9:00
Opening and Welcome
9:00 - 9:30
MedDRA Overview
Yuxiu LIU
Professor, Director of Department of Medical Statistics,
Nanjing General Hospital of Nanjing Military Region
9:30 - 10:30
MedDRA Coding Rules and Skills
Pansie ZHANG
Senior Specialist, Clinical Data Management, MSD
10:30 - 12:00 MedDRA Coding Exercises
Pansie ZHANG
Senior Specialist, Clinical Data Management, MSD
Dejuan DUAN
Clinical Data Manager, MSD
12:00 - 13:30 Lunch
13:30 - 14:00 WHO DD Overview
Xiaofei YE, MD, PhD
2nd Military Medical University
14:00 - 14:45 WHO DD Dictionary Format and Structure
Ellene CARIN
Senior Coding Specialist, WHO Drug Production
Uppsala Monitoring Centre
14:45 - 15:15
WHO DD Browser
Tao GAO
Clinical Data Manager, Covance
15:15 - 15:30
Tea Break
59
迎接法规变革,聚力专业质量
2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
60
SUNDAY, 15 MAY | PRCONFERENCE WORKSHOPS
15:30 - 16:45 WHO DD Coding Skills and Coding Exercises
Tao GAO
Clinical Data Manager, Covance
Liyang LIU
Clinical Data Coordinator, Covance
16:45 - 17:00 Coding Tools
Tao GAO
Clinical Data Manager, Covance
Wrap Up
17:00
Peter WANG
Business Development Director, Tigermed Co., Ltd.
AGENDA
8:30–8:35
Opening Remarks
8:35–9:15
Our Perception of CFDA Regulations on
Simultaneous Submission of Innovative Drugs
Maggie CHANG
Consultant, Drug Regulatory Policy, Tigermed
9:15–9:55
SUNDAY, 15 MAY
Workshop
3
08:30–17:00 | 3rd Floor, 302A
Strategy and Key Considerations
for Simultaneous Filing of
Innovative Drugs in China and
Abroad
With a rapid growth of R&D talents and introduction of
technologies in biopharmaceutical research, the focus of China’s
pharmaceutical R&D has gradually changed from tranditiaonal
generic drugs and API manufacturing to innovative drugs. In the
meantime, the targeted market of pharmaceutical R&D in China
is also changing from domestic to both domestic and abroad. A
series of new regulations and policies issued by CFDA recently
indicates that simultaneous filing of innovative drugs in China
and the US/EU is one of the fast track review options. Under
such circumstances, more and more pharmaceutical companies
in China are considering simultaneous filing strategy for their
innovative drugs.
This purpose of this workshop is to provide an opportunilty for
pharmaceutical companies to have a thorough understanding of
the current regulatory environment related to simutaneous filing,
to learn key steps and considerations of filing an IND with the
US FDA with a focus on key elements in CMC, preclincial safety,
design of phase I clinical trial and bioanalysis.
TARGET AUDIENCES
•Senior Executives
•Regulatory Affairs
•Nonclinical Safety
•CMC
•Bioanalysis and PK/PD
•Clinical Research and Development
•Portfolio Management
•Strategy
PROGRAM COMMITTEE
Joe ZHANG, MD, PhD
Executive Deputy Head, Center of Medicinal and Translational
Sciences, Shanghai CP Guojian Pharmaceuticals CO. Ltd
Xiaochun CAO
Executive Vice President & Board Secretary, Tigermed
Consulting Ltd.
US FDA General Policies and Procedures for
Investigational New Drug (IND) Applications
Jiaqin YAO, PhD
Chief Scientific Officer, Shanghai Innostar Bio–Tech
9:55–10:10
Tea Break
10:10–10:50
Planning and Strategy for Drug Multi-Country
Submission
Pengcheng KANG
Vice President, Beijing Canny Consulting Inc.
10:50–11:30
Planning and Strategy for Simultaneous
Submission: CMC and Clinical Batch Manufacture
Perspectives
Allen ZHANG, PhD
Vice President, CMC, Frontage Laboratories, Inc.
11:30–12:00
Q&A
12:00–13:30
Luncheon
13:30 – 14:15 Nonclinical Data Required to Support IND and
NDA by CFDA and US FDA
Dylan YAO, PhD
Chief Scientific Officer, JOINN Laboratories (Beijing) Inc.
14:15–14:55
Key Considerations of Phase I Clinical Design
Pei HU, PhD
Professor, Director, Clinical Pharmacological Research Center,
Peking Union Medical College Hospital
14:55–15:10
Tea Break
15:10–15:50
Bioanalytical Strategy and Key Considerations for
Simultaneous Filing of Innovative Drugs Globally
and in China
Jinsong XING, PhD
President, Xihua Scientific Inc., Ltd.
15:50–16:30
Opportunities and Challenges of Global
Simultaneous Development
Irene DENG
Vice President, Regulatory Affairs, AstraZeneca
16:30–17:00
The Differences of Personalized Health Care
between China and EU
Ruth E. MARCH, PhD
Vice President, Personalized Healthcare and Biomarkers,
AstraZeneca, UK
17:00–17:30
Panel Discussion
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
61
SUNDAY, 15 MAY | PRCONFERENCE WORKSHOPS
SUNDAY, 15 MAY
Workshop
4
08:30–17:00 | 3rd Floor, 302B
CDISC Standards for
Clinical Trial
AGENDA
8:30 - 8:45
Victor WU, PhD
Authorized SDTM Instructor, Vice Chair of C3C; AD, Biostatistics
and Programming, PPD
8:45 - 9:30
Good quality of data is critically important, and standardization
is very important for improving data quality. With the
standardization, we can focus more on more important points
on science and planning, instead of doing it; we can develop
tools to help us identify the data issues at very early time, and
perform real time analysis or regular analysis to detect the
trends. The requirement of self-inspection from China regulatory
agency, emphasized the importance of data quality and data
standardization. CDISC is data standard mainly for clinical trial,
covering protocol presentation, CRF design, data tabulation,
analysis data, data exchanging and archiving. CDISC standards
provide us the common languages for us to communicate on
data, and on clinical trial. Here we will do an overall introduction
of CDISC standards related data management, statistics, and
medical/Regulatory review activities.
LEARNING OBJECTIVES
•General Understanding of CDISC
•Learn How to Use CDISC in Kinds of Activities in Clinical Trial
- CRF Design
- Data Tabulation and Submission
- Prepare Analysis Dataset
- Regulatory/Medical Review
TARGET AUDIENCE
•Data Management Professionals
•Statistics and Programming Professionals
•Clinical Safety/Pharmacovigilance Professionals
•Training Professionals
•Medical Professionals
•Regulatory Reviewer
PROGRAM CHAIR
Victor WU, PhD
Authorized SDTM Instructor, Vice Chair of C3C; AD, Biostatistics
and Programming, PPD
KEY SPEAKERS
Dehong CAO
Reporting and Mapping Manger, MSD R&D (China) Co.Ltd
Aimee WANG
Senior Global Data Management Specialist, Global Data
Management and Standards, MSD R&D (China) Co. Ltd
Wenjun BAO, PhD
Chief Scientist, R&D Manager, JMP Life Science
SAS Institute Inc., USA
Welcome and Opening Remark
Session 1: CDISC Overview
Victor WU, PhD
Authorized SDTM Instructor, Vice Chair of C3C; AD, Biostatistics
and Programming, PPD
1. CDISC organization and CDISC standards overview
2. CDISC in China
9:30 – 10:15
Session 2: SDTM – Principle
Dehong CAO
Reporting and Mapping Manger, MSD R&D (China) Co.Ltd
1. SDTM Basic
2. General Observation Class
10:15 – 10:30 Coffee Break
10:30 – 11:00 Session 3: SDTM – Implementation by Examples
Dehong CAO
Reporting and Mapping Manger, MSD R&D (China) Co.Ltd
1. Difference: Standard vs Non-Standard
2. SDTM examples
• Demographics • Vital Signs • Adverse Event
• Concomitant Medication
11:00 – 12:00 Session 4: Best Practice in CRF design – CDASH
Aimee WANG
Senior Global Data Management Specialist, Global Data
Management and Standards, MSD R&D (China) Co. Ltd
1. CDASH overview
2. CDASH conformant CRF examples
• Demographics • Vital Signs • Adverse Event
• Concomitant Medication
12:00 – 13:30 Lunch
13: 30 – 15:15 Session 5: Best Practice in Preparing Analysis
Datasets - ADaM
Victor WU, PhD
Authorized SDTM Instructor, Vice Chair of C3C; AD, Biostatistics
and Programming, PPD
1. ADaM overview
2. ADaM examples: data structures and common analysis
supported
ADSL/ADVS/ADTTE/ADAE
Chi-squared/Mixed Models Analysis/Regression, Cox
15:15 – 15:30 Coffee Break
15:30 – 17:00 Session 6: Review with CDISC Data
Wenjun BAO, PhD
Chief Scientist, R&D Manager, JMP Life Science
SAS Institute Inc., USA
1. Risk/Fraud detecting with CDISC data
2. Regulatory/Medical Review with CDISC Data
17:00
Summary and Close
62
迎接法规变革,聚力专业质量
2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
MONDAY 16 MAY | OPENING PLENARY
Opening Plenary Session | Monday, 16 May
Simultaneous
Translation
13:30-17:30
INTRODUCTION AND ACKNOWLEDGEMENT
Carol ZHU, MBA
Senior Vice President and Managing Director,
DIA Greater China
OPENING REMARK
Barbara Lopez KUNZ
Global Chief Executive, DIA
WELCOME ADDRESS
Jingsong WANG, MD, PhD
Advisor to Atlas Venture
8th DIA China Annual Meeting Program Co-Chair
Bin XUE
Director-General, China Center for Food and Drug
International Exchange, CFDA
8th DIA China Annual Meeting Program Co-Chair
WELCOME ADDRESS FROM CFDA
Lin YUAN
General Director, Department of International Cooperation
(Office of Hong Kong, Macao and Taiwan Affairs), CFDA
AWARD CEREMONY
DIA China Excellence in Service Award will be presented
during the opening plenary session.
KEYNOTE ADDRESS:
THE INNOVATION PATHWAY OF CHINA’S NEW DRUG
Xiaodong WANG, PhD
Founder & Chairman, Scientific Advisory Board, BeiGene
Member of National Academy of Sciences, USA
Founding Director & Architect of 700-person team at the
National Institute of Biological Sciences (NIBS) in Beijing
(2003-present)
KEYNOTE ADDRESS:
MEDICAL INNOVATION: A CATALYST FOR A HEALTHY AND
PROSPEROUS CHINA
Mark J. ALLES
Chief Executive Officer, Celgene, USA
SPECIAL FORUM: INNOVATION AND QUALITY
MODERATOR
Zhi’ang WU, PhD
Professor, Dean, School of Business Administration, Shenyang
Pharmaceutical University
Innovation and quality, are the most important topics under
the China’s new regulatory reform environment. This special
designed forum will explore the internal relationship between
innovation and quality to seize the new trends, as well play a
significant role in studying the specific strategies. The invited
guests from authority, scientific, academia and industry will be
sitting together to share their views and opinions and conduct
the in-depth discussion with the audiences.
INVITED PANELISTS
CFDA Panelist Invited
Haidong WU
Deputy Director-General, Division of Consumer Goods
Industry, Ministry of Industry and Information Technology of
the People’s Republic of China
Guanhua DU
Professor, Vice President, Institute of Materia Medica, Chinese
Academy of Medical Sciences & Peking Union Medical College
Ying SHAO, PhD
Vice President and Director of R&D Center, Shanghai Fosun
Pharmaceutical (Group) Co., Ltd.
Ning XU, MD, PhD, MBA
Executive Vice President, Head of Clinical Development and
Regulatory Affairs, Zai Lab
James CAI, MD, PhD
Vice President, Global Regulatory Affairs and Patient Safety
for Japan, Australia and Asia, Amgen Asia Holding Limited
Welcome Reception | Monday, 16 May
17:30-19:00 | 1st Floor, Ballroom A+B
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
TUESDAY, 17 MAY | WEDNESDAY, 18 MAY
63
THEME 1
eCTD’s Implementation and Preparation in APAC and China
Theme
1
Rapid Evolving China Regulatory
Science – Seize the Opportunity for
Driving Innovation
Session 0101 | Tuesday, 17 May
Simultaneous
Translation
08:30–10:00 | 3rd Floor, 311A
ENHANCEMENT FOR POST-MARKETING COMMITMENT
CLINICAL TRIALS TO REALIZE ACCELERATED APPROVALS
SESSION CHAIR
Yi FENG, PhD
Senior Vice President, Medical and Regulatory Affairs
Fountain Medicine Co. Ltd.
To meet unmet medical needs as early as possible, the regulatory
approval is more flexible nowadays. As a result that more and
more products have been approved base on limited clinical
efficacy and safety data or surrogated clinical endpoints, post
approval study or supervision plays a more important role than
before. This session is to share and discuss the consideration,
requirement and new trend in this area across the countries and
region.
Post Approval Requirement after Acceleration Approval from US
FDA’s Perspective
Jing ZHANG, MD, PhD
Former Medical Team Leader, Division of Psychiatry Products,
Office of New Drug, Center of Drug Evaluation and Research,
FDA, USA
Post Approval Requirement in Japan after Acceleration Approval
Tetsuomi TAKANO, RPh
Senior Director, Head of Asian Development Strategy
Astellas Pharma Inc., Japan
Post Approval Requirement after Acceleration Approval from
CFDA’s Perspective
CFDA Speaker Invited
Session 0102 | Tuesday, 17 May
10:30–12:00 | 3rd Floor, 311A
eCTD: Implementation and Preparation
SESSION CHAIR
Lixian MA
Regulatory Manager, Roche
Along with the availability and popularity of internet as well
as the harmonization of technical requirement and regulatory
document format, eCTD submission has been widely adopted by
health authority worldwide. This session aims to introduce and
discuss the progress of eCTD in different countries and region,
and might also be helpful to the upcoming China eCTD scheme.
eCTD’s Global Development and Current Status in APAC
Raoul-A. LORENZ
Chief Executive Officer, LORENZ Life Sciences Group
Ivy TAN
Head, China Regulatory Operations, Johnson & Johnson
eCTD’s Global Implementation and Preparation
Li LIN, PhD
Director of Generics R&D, Head of Development & Regulatory
Affairs, Jiangsu Hengrui Medicine Co., Ltd.
Panel Discussion
All Speakers Above and Invited Panelist:
CFDA Panelist Invited
Session 0105 | Wednesday, 18 May
Simultaneous
Translation
08:30–10:00 | 3rd Floor, 311A
BEST PRACTICE FOR COMMUNICATION BETWEEN SPONSORS
AND HEALTH AUTHORITIES
SESSION CHAIR
Wendy YAN, MD, MBA
Senior Vice President, Head of Regulatory Affairs, BeiGene
(Beijing) Co., Ltd.
Effective communication between sponsor and health authorities
is one of the key factors to ensure drug development to follow
the appropriate strategy and accelerate the review process. FDA
set up a record for approve a NDA application in 5 days. Such
achievement is also related to the good communication between
FDA and the sponsor. Many countries’ health authorities provide
guidance for communication for sponsor. In this session, speakers
from HA and industry will share their thought and best practice
for communication between sponsor and HA.
FDA’s Best Practice for Communication with Sponsors
Gerald DAL PAN, MD
Director, Office of Surveillance and Epidemiology, CDER, FDA,
USA
PMDA’s Best Practice for Communication with Sponsors
Daisuke MAEDA, PhD
Division Director, Review Planning Division,
Office of Review Management, Pharmaceuticals and Medical
Devices Agency (PMDA)
Sponsor’s Best Practice for Communication with Health
Authorities
Qingzhu HUANG
Coordinator, Administration, Center for Drug Evaluation, CFDA
Session 0106 | Wednesday, 18 May
Simultaneous
Translation
10:30–12:00 | 3rd Floor, 311A
EXPEDITED PATHWAY TO FACILITATE DRUG DEVELOPMENT
SESSION CHAIR
Wendy YAN, MD, MBA
Senior Vice President, Head of Regulatory Affairs , BeiGene
(Beijing) Co., Ltd.
In order to facilitate and expedite drug development and review
of new drug to address unmet medical needs in the treatment
of a serious or life threatening condition, health authorities from
many countries set up expedited pathway to shorten the review
64
迎接法规变革,聚力专业质量
2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
TUESDAY, 17 MAY | WEDNESDAY, 18 MAY
THEME 1 | THEME 2
timeline from submission to approval. In this section, we would
like to invite the speakers from US, Japan and China to share
their strategy and guidance on using expedited pathway to
facilitate drug development and market.
Shanghai Green Valley Pharmaceutical Ltd.
CDE’s Expedited Pathway to Facilitate Drug Development
HOW TO ESTABLISH PROPER IND FRAMEWORK IN CHINA –
PART 2: SUPPORTING SYSTEM
SESSION CHAIR
Zhimin YANG
Senior Reviewer, Acting Director (Acting), Office of Clinical
Department I, Center for Drug Evaluation, CFDA
FDA’s Expedited Pathway to Facilitate Drug Development
Jing ZHANG, MD, PhD
Former Medical Team Leader, Division of Psychiatry Products,
Office of New Drug, Center of Drug Evaluation and Research,
FDA, USA
“SAKIGAKE”- Japan’s Expedited Pathway
Jun KITAHARA, PhD
Director, Division of Regulatory Cooperation
Office of International Programs,
Pharmaceuticals and Medical Devices Agency (PMDA)
Session 0107 | Wednesday, 18 May
Simultaneous
Translation
13:30–15:00 | 3rd Floor, 311A
HOW TO ESTABLISH PROPER IND FRAMEWORK IN CHINA
– PART 1: FILING AND REVIEW PROCESS AND DOSSIER
REQUIREMENT
SESSION CHAIR
Joan SHEN, MD, PhD
Vice President
Development Head China R&D and Medical Affairs
Janssen Pharmaceutical Companies of Johnson & Johnson
CFDA is initiating regulatory management system reform.
Industry is expecting some fundamental changes to be
introduced as the mindset change has been clearly observed by
published several policy paper. IND/NDA separation has been a
hot topic in past years in China and many related discussions
were conducted in various occasions. Exploring China IND
system is becoming more and more critical now as it is not only
the need of MNCs but also the domestic innovative companies.
Proper IND system reflecting R&D principle will help the healthy
and fast evolvement of China pharmaceutical industry from
generic oriented to innovative oriented. This session is aiming
to discuss this important question from filing and review process
and dossier requirement perspective by introducing FDA system,
sharing real experience from domestic company in China, and
on that basis to propose some thoughts or suggestion to China
IND system.
Simultaneous
Translation
Session 0108 | Wednesday, 18 May
15:30–17:30 | 3rd Floor, 311A
Theresa LI
Regulatory Affairs Director, Janssen China
CFDA is initiating regulatory management system reform.
Industry is expecting some fundamental changes to be
introduced as the mindset change has been clearly observed by
published several policy paper. IND/NDA separation has been a
hot topic in past years in China and many related discussions
were conducted in various occasions. Exploring China IND system
is becoming more and more critical now as it is not only the need
of MNCs but also the domestic innovative companies. Proper
IND system reflecting R&D principle will help the healthy and
fast evolvement of China pharmaceutical industry from generic
oriented to innovative oriented. This session is aiming to discuss
this important question from supporting system perspective,
such as IRB, clinical site inspection, clinical hold and PV, by
introducing FDA system, sharing real experience from domestic
company in China, and on that basis to propose some thoughts
or suggestion to China IND system.
US FDA IND System- Supporting System
Derek ZHANG, PhD
Independent Pharmaceutical and Regulatory Consultant
Former Senior Clinical Pharmacology Reviewer, Office of Clinical
Pharmacology, CDER, FDA, USA
Experience Sharing IND Experience in US and China
Joan SHEN, MD, PhD
Vice President, Development Head
China R&D and Medical Affairs, Janssen Pharmaceutical
Companies of Johnson & Johnson
Panel Discussion
All Speakers from Session 0107 & 0108
US FDA IND System - Process and System from Biological
Perspective
Hugh DAVIS, PhD
Vice President and Head, Biologics Clinical Pharmacology and
JBIO China Leader, Janssen BioTherapeutics
Inside the Opportunities and Challenges to Conduct Clinical
Trials in Australia
James PANG, MD, PhD
Senior Vice President
Making Connections
Fostering Relationships
Advancing Innovation
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
TUESDAY, 17 MAY | WEDNESDAY, 18 MAY
Theme
2
China Food and Drug
Administration (CFDA) Town Hall
Rose McCormack, PhD
Director of Global Products, AstraZeneca, UK
Role and Advancement of Companion Diagnostics (CDx) in
NSCLC Management
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CHINA FOOD AND DRUG ADMINISTRATION (CFDA) TOWN
HALL
SESSION CO-CHAIRS
Bin XUE
Director-General, China Center for Food and Drug International
Exchange, CFDA
Carol ZHU, MBA
Senior Vice President and Managing Director, DIA Greater China
CFDA Townhall this year is intended to communicate with the
audiences on the hot topics related to international collaboration,
overseas inspections with regard to GMP and GCP, expedited
pathway to facilitate drug development and internal talent
training program etc.
Department of Drug and Cosmetics Registration (Department of
TCMs and Ethno- Medicines Supervision), CFDA Speaker Invited
Department of Legal Affairs, CFDA Speaker Invited
Center for Drug Evaluation, CFDA Speaker Invited
Department of International Cooperation (Office of Hong Kong,
Macao and Taiwan Affairs), CFDA Speaker Invited
3
THEME 3
The Discovery and Development of 3rd Generation EGFR TKI
Inhibitor
Session 0203 & 0204 | Tuesday, 17 May
Theme
65
Mike ZHU, MD, PhD
Executive Vice President, Amoy Diagnostics, Co. Ltd
Session 0302 | Tuesday, 17 May
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10:30–12:00 | 3rd Floor, 311B
BREAKTHROUGH OF DRUG DEVELOPMENT AND PATIENT
MANAGEMENT IN KEY RESPIRATORY DISEASES
SESSION CHAIR
Min IRWIN, MD, PhD
Former Vice President, Medicines Development,
GlaxoSmithKline
Asthma and chronic obstructive pulmonary disease (COPD)
represent the leading chronic respiratory diseases of interest
in the word, owing to their high prevalence and burden on the
health system. Care of these patients, undergoing frequent
exacerbations, is a heavy burden on healthcare systems. In the
last few years, large improvements in the management of asthma
and COPD have been made, owing to new drugs and management
strategies, and to the improvement of the nonpharmacologic
treatment of COPD. There are still many unmet needs in the
treatment of these diseases. New perspectives include the use of
biologic drugs (anticytokine monoclonal antibodies) in selected
categories of severe asthmatics, potential new inhibitors of
chemokines and cytokines involved in the pathobiology of
asthma and COPD, and a further improvement of current
drugs and better implementation of management strategies,
particularly in COPD patients.
Advances in Medicine Development in Asthma and COPD as well
as Future Opportunities and Challenges
Innovative Breakthrough in
Therapy
Aik GOH, MD
Director, Respiratory TA Lead, China Medical, GSK
Current Clinical Progression on the Treatment of Asthma and
COPD
Session 0301 | Tuesday, 17 May
Simultaneous
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08:30–10:00 | 3rd Floor, 311B
ADVANCEMENT OF NSCLC MANAGEMENT – IMPLICATION OF
PRECISION MEDICINE TO PERSONALIZED CARE
SESSION CHAIR
George CHEN, MD, MBA
Vice President and Head of Global Medicine Development
China, AstraZeneca (China)
Overview on the Progress of EGFR mut NSCLC Diagnosis
and Treatment
Harry REN, PhD
Shanghai Pulmonary Hospital, Tongji University
Jinming GAO, PhD
Professor, Respiration Medicine, Peking Union Hospital
The Landscape of Innovative Medicines in Respiratory Diseases
and the China Contribution
Michael HUMPHRIES, PhD
Head, Respiratory Development, Novartis China
Panel Discussion: Optimization of Medicine Development for
Respiratory Diseases in China and Unique Opportunities and
Challenges
All Speakers Above and Invited CFDA Panelist
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2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
TUESDAY, 17 MAY | WEDNESDAY, 18 MAY
Session 0305 | Wednesday, 18 May
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THEME 3
Session 0306 | Wednesday, 18 May
8:30–10:00 | 3rd Floor, 311B
10:30–12:00 | 3rd Floor, 311B
THE CLINICAL RESEARCH OF NEW VACCINES
SESSION CHAIR
BREAKTHROUGH OF HEPATITIS TREATMENT IN CHINA
SESSION CO-CHAIRS
Sean DU, PhD
Senior Director and Head of External R&D Asia Pacific,
Sanofi Pasteur
Jessica LIU
Vice President Clinical Development, General Medicine BU,
Asia–Pacific Region, INC Research
In recent years, vaccine research and development have become
increasingly active in Asia, particularly in China. Several firstin-class vaccines, including HEV vaccine, Sabin IPV, and EV71
vaccine, have completed their phase III efficacy trials, met their
primary end points, and been approved by CFDA. Other novel
vaccines against Ebola, TB, and HIV-1, as well as best-in-class
vaccines against HPV, have also steadily progressed into different
clinical testing stages. This, combined with a continuous reform
and improvement of the regulatory environment in the region,
will promote a more sophisticated clinical testing system, a more
robust clinical candidate pipeline, and more thinking on ex-China
strategy to benefit other part of the world with the vaccine
success from China. This vaccine session is hence dedicated to
the clinical development of new vaccines in China and aiming to
provide a platform to showcase our achievements and discuss
perspectives on challenges and opportunities.
Phase II Study of Ebola Vaccine in Africa
Fengcai ZHU
Professor of Clinical Research, Deputy Director of Jiangsu CDC, Head of Vaccine Clinical
Research Center, Jiangsu Province Center for Disease Control
and Prevention
The Immunological Assay in the Clinical Research of Inactive
EV71 Vaccine
Qihan LI
Professor, Director, Institute of Medical Biological Chinese
Academy of Medical Science
“In China for Global”-- Challenges and Opportunities of the
Internationalization of Local Vaccines
Wenjun SUN
Senior Program Officer, Research and Development
BILL & MELIDA GATES Foundation
Panel Discussion: The Challenges and Solutions of Phase III
Efficacy Studies of HPV Vaccine in China
All Speakers Above and Invited Panelists
Youlin QIAO
Professor, Cancer Hospital, China Academy of Medical Science
(CAMS)
Jun ZHANG, PhD
National Institute of Diagnostic and Vaccine Development in
Infectious Diseases, Xiamen University
Li SHI, PhD
Chief Executive Officer, Shanghai Zerun Biotechnology Co., Ltd
Jidong JIA, MD, PhD
Professor of Medicine, Director, Liver Research Center, Beijing
Friendship Hospital, Capital Medial University
In the past few years, with the rapid development of direct
acting antiviral agents (DAAs), treatment of chronic hepatitis C
infection has been revolutionized. Most of the chronic hepatitis
C patients can now be cured with interferon-free pan-oral
therapy with a short duration of therapy. However, clinical data
on the use of these DAAs is grossly lacking in Chinese. And there
are also important clinical issues, such as duration of therapy,
pharmaco-economic, patients with advance liver diseases that
drive physicians, scientists, pharmacologists for the continuous
efforts with even more innovative clinical development plan.
Hepatitis B+C treatment in China and New Development Focus
Jidong JIA, MD, PhD
Professor of Medicine, Director, Liver Research Center, Beijing
Friendship Hospital, Capital Medial University
HBV Treatment Innovation - Drug Clinical Development Plan
Dajun YANG, PhD
Chief Executive Officer, Ascentage Pharma
All Oral DAA Regiments Development by Chinese Companies:
Progress and Breakthrough
Jinzi WU, PhD
Founder, President and CEO, Ascletis BioScience Co., Ltd
Panel Discussion: Innovative Approach of Local Development of
Anti-hepatitis Therapy in China
All Speakers Above and Invited Panelist
Lai WEI, MD, PhD
Professor, Director, Peking University Hepatology Institute
Vice President, Medical Service, Peking University People’s
Hospital
CFDA Panelist Invited
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
TUESDAY, 17 MAY | WEDNESDAY, 18 MAY
Session 0307 | Wednesday, 18 May
13:30–15:00 | 3rd Floor, 311B
Simultaneous
INNOVATIVE MEDICINES IN CARDIOVASCULAR AND
Translation
METABOLIC FIELD MADE HUGE IMPACT ON CARDIOVASCULAR
TREATMENT
SESSION CHAIR
Min IRWIN, MD, PhD
Former Vice President, Medicines Development,
GlaxoSmithKline
In the past few years, with many cutting edge advances in
pharmaceuticals and diagnosis the treatment of cardiovascular
and metabolic diseases has been revolutionized. Many of patients
with CV problems can now chose drugs with different mechanism
of therapies. However, there are also important clinical issues,
such as duration of therapy, pharmaco-economic, patients with
co-diseases that drive physicians, scientists, pharmacologists
for the continuous efforts with even move innovative clinical
development plans.
Advances and Unmet Medical Needs on Treatment of
Cardiovascular and Metabolic Diseases
Changsheng MA, PhD
Professor, Director, Cardiovascular Medicine, Anzhen Hospital
Overview of Therapeutic Antibodies Development: Evolocumab
Case Study
Zhigang YU, PhD
Medical Development Director, Amgen
Disease Burden and Treatment Breakthrough of Heart Failure
in China
Lingli LIU, MD
Associate Director, Head of CV Medical Franchise, Novartis
Optimization of Clinical Development for CV diseases in China From the Agency Perspective
Tao WANG
Acting Director (Acting), Office of Clinical Department II,
Center for Drug Evaluation, CFDA
Theme
4
Clinical Trial Sites in China –
Bottleneck or the Anchor for
Quality Clinical Trials
Session 0401 | Tuesday, 17 May
08:30–10:00 | 3rd Floor, 310
CFDA INSPECTION: WHETHER A BRIGHT SUNNY SKY WILL
APPEAR AFTER HAZE SWEPT OFF
SESSION CHAIR
Shuting LI, MD
Vice Director, GCP Center, the Cancer Hospital of Chinese
Academy of Medical Sciences
Last year CFDA started the strictest inspections of IND clinical
trials, as a result, hundreds of enterprises, CRO and research
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THEME 3 | THEME 4
institutions have been involved, and nearly one thousand
IND applications have been withdrawn. Clinical trial sites and
industries have undergone the great movement of inspections.
After this movement people wonder whether the haze can be
swept off, a clean environment of clinical trials can appear, and
what is the right way to do clinical trials, all this become a hot
topic for both sites and drug companies/CROs to consider and
discuss. In this session speakers from pharmaceutical companies,
CROs and research sites will give their views and discuss it
respectively.
It’s Really Hard for Clinical Sites to Say “I love you”
Yongchuan CHEN
Director, GCP Office, Southwest Hospital
The Common Road of Pursuit: Co–operation, Win–Win, and
Promotion
Jessie ZOU, MD, PhD
Vice President, Clinical Research & Development – Oncology,
Jiangsu Hengrui Medicine Co. Ltd.
Panel Discussion: To Improve the Quality: Based on the
Respective Responsibilities and Trust to Reach a Common View
and Double–Win
All Speakers Above and Invited Panelists:
Xiquan ZHANG
Vice President, Chia Tai Tianqing Pharmaceutical Group Co. Ltd.
Shuqi LI
Vice President, R&G Pharma Studies Co., Ltd., Inc.
Session 0402 | Tuesday, 17 May
10:30–12:00 | 3rd Floor, 310
RISK BASED QUALITY CONTROL: HOW TO HAVE A GOOD
COOPERATION BETWEEN CRA AND CRC?
SESSION CHAIR
Shuting LI, MD
Vice Director, GCP Center, the Cancer Hospital of Chinese
Academy of Medical Sciences
Risk based monitoring is a new method of quality control
recommended by foreign drug companies. After a period of
implementation in our country, the investigators/CRCs and
sponsors/CRAs have got some experience, and also met some
problems. Therefore, how to carry out a risk–based monitoring
and meanwhile ensure the quality control of clinical trials in
this country is one of the hot topics nowadays. In this session
panelists including sponsors and SMOs will have a thorough
discussion from respective aspects. The focus is on how to have
a good collaboration between CRAs and CRCs
Current Clinical Research Monitoring Practice, Problems and
Considerations
George GUO
Global Monitoring Operation Country Head,
Novartis Pharmaceuticals (China) Oncology
Challenge for CRCs to A Risk-Based Approach to Monitoring
Mingli XU
General Manager, Beijing HMO Medicine Technology Co.,Ltd
迎接法规变革,聚力专业质量
2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
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THEME 4 | THEME 5
Panel Discussion: Risk Based monitoring: Do You Know Where
the Risk Is?
Session 0506 | Wednesday, 18 May
All Speakers Above and Invited Panelists:
TO BE OPERATIONAL EXCELLENCE IN CLINICAL TRIALS PART 2
SESSION CHAIR
Jianhui SUN
Study Management Lead, Pfizer
Yue WANG
Clinical Research Coordinator, SMO–Clinplus Co.Ltd.
5
It’s full of challenges to conduct high quality clinical trials in
China. And given the large patient population and diverse
diseases, China has its resources and professionals to contribute
more evidence-based data to health care industry.
Operational Excellence – China’s
Own Challenges and Unique
Opportunity
Session 0505 | Wednesday, 18 May
10:30–12:00 | 3rd Floor, 310
Christina PING
Chief Executive Officer, Chelsea Clinical Research, China
Arron LIU
General Manager, Beijing Linkstart –SMO
Theme
Simultaneous
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08:30–10:00 | 3rd Floor, 310
TO BE OPERATIONAL EXCELLENCE IN CLINICAL TRIALS PART 1
SESSION CHAIR
As one of the stakeholder of Clinical Operations – Site/SMO,
what are their own main challenges, especially in recent years?
And how do they do to ensure and enhance the Operational
Excellence at their role in Clinical Trials?
The Challenges Faced in Conducting Clinical Trials from Site
Point of View
Shen QU, MD, PhD
Professor, Director, Endocrine and Metabolism, Shanghai 10th
People’s Hospital Tongji University
CRC’s Role in Conducting Excellent Clinical Operations
Amy JIANG
Quality Operations, China/AP R&D, Sanofi
Tianxun WANG
General Manager, Premium Site Management Co.,Ltd.
It’s full of challenges to conduct high quality clinical trials in
China. And given the large patient population and diverse
diseases, China has its resources and professionals to contribute
more evidence-based data to health care industry.
Session 0507 | Wednesday, 18 May
As one of the stakeholder of Clinical Operations – Sponsor/CRO,
what are their own main challenges, especially in recent years?
And how do they do to ensure and enhance the Operational
Excellence at their role in Clinical Trials?
The Challenges Faced in Conducting Clinical Trials from Sponsor
Point of View
Dennis Anthony WONG, MD
Associate Vice President, Head of Development, Asia Pacific
R&D, Sanofi (China) Investment Co., Ltd. Shanghai Branch
The Challenges Faced in Conducting Clinical Trials from CRO
Point of View
Jasmine SUN, MD, MPH
Senior Medical Director, Medical Oncology
Tigermed Consulting Co., Ltd.
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13:30–15:00 | 3rd Floor, 310
TO BE OPERATIONAL EXCELLENCE IN CLINICAL TRIALS PART 3
SESSION CHAIR
Ning XU, MD, MBA
Executive Vice President,
Head of Clinical Development and Regulatory Affairs, Zai Lab
With good standard in the industry and good wishes/behaviors
in Clinical Operations from all stakeholders, we can anticipate
the high quality clinical trials in China tomorrow.
Panel Discussion
All Speakers from Session 0505, 0506 & 0507 and
Invited Panelist:
Jun FU, MD, PhD
Director, GCP Center, Shanghai 10th People’s Hospital Tongji
University
Patients as Partners: An Opportunity to Enhance Clinical Trials
Richard MURRAY, MD
Vice President, and Deputy Chief Medical Officer, Merck Sharp &
Dohme, USA
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
TUESDAY, 17 MAY | WEDNESDAY, 18 MAY
Theme
6
Quantitative Science – The
Backbone of Evidence Based Data
Generation
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THEME 6
Real World Data for Evidence–Based Medicine, an Industry
Perspective to Consolidate Value, Evidence and Outcome
Yi NING, PhD
Head of Epidemiology, GSK Shanghai
Bingming YI, PhD
Head of Statistics, Epi, and Data Management, GSK Shanghai
Real World Evidence – Essential Component for a Holistic Value
Story
Session 0601 | Tuesday, 17 May
08:30–10:00 | 3rd Floor, 303A
BRIDGE THE REAL WORLD TO THE CLINICAL DEVELOPME NT
– PART 1: METHOD & APPLICATION
SESSION CHAIR
Ke WANG, PhD
Senior Health Outcome Consultant, Medical,
Eli Lilly and Company China
Panel Discussion
Invited Panelists:
Tong GUO, PhD
Head Data Sciences & Analytics Beijing
Global Development Beijing, Bayer HealthCare Company
CFDA Panelist Invited
Real world evidence is essential to identifying unmet medical
need, optimizing the clinical development and demonstrating
the actual clinical and economic impact of interventions. The
evidence enables the pharmaceutical industry to prioritize the
pipeline investment more effectively and better understand
underlying causes of disease and identify opportunities for
indication expansion and clinical development. It also allows
demonstrating the clinical and economic value of the products
to payers to deploy health solutions. Laying a solid foundation to
capture the quantitative evidence is critical to bridge the clinical
development to the real world for the true integration of health
care and therapeutics.
Biomarker Thresholding and Application in Treating Pediatric
Neuroblastoma
Xiaoshan WANG, PhD
Principal Biostatistician, Harvard School of Dental Medicine,
USA
Building Reliable Quantitative Evidence from Real–World Data to
Drug Development and Approval
Xiaoxiang CHEN, MD
Vice President, Regional Medical Manager, Boehringer–
Ingelheim
Steve SNAPINN
Vice President, Statistics and Data Management, Amgen
Eric WU
Managing Principal, Analysis Group Inc.
Session 0605 | Wednesday, 18 May
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08:30–10:00 | 3rd Floor, 303A
DATA QUALITY AND INTEGRITY - PART 1: CLINICAL TRIAL
DATA MANAGEMENT AND COLLABORATED QUALITY
CONTROL
SESSION CHAIR
Carrie ZHANG
Regional Director, Clinical Data Management, Global Data
Management & Standard – Asia Pacific CT, MSD R&D (China)
Co., Ltd
Julie CONG, PhD
Senior Associate Director, Biostatistics/Biostatistics and Data
Sciences, Boehringer Ingelheim Pharmaceutical Inc., USA
Clinical trial data consist of EDC dataset and external dataset.
Site source data control has a great influence to EDC data
quality as well. This session will invite global top company data
management leaders to introduce data capture and quality
control approach from below dimensions.
Comparative Effectiveness Study without Head to Head Clinical
Data
Clinical Trial Data Integrated Quality Control
Eric WU, PhD
Managing Principal, Analysis Group Inc.
Simeng HAN, PhD
Director of China, Analysis Group Inc.
Session 0602 | Tuesday, 17 May
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10:30–12:00 | 3rd Floor, 303A
BRIDGE THE REAL WORLD TO THE CLINICAL DEVELOPMENT –
PART 2: EVOLVEMENT AND FUTURE DIRECTIONS
SESSION CHAIR
Luyan DAI, PhD
Head of Statistics China, Biostatistics & Data Sciences Asia,
Boehringer–Ingelheim
Carrie ZHANG
Regional Director, Clinical Data Management, Global Data
Management & Standard – Asia Pacific CT, MSD R&D (China)
Co., Ltd
External Data for Quality Trial Data Assurance – Central Lab
Sebastiano MANGHI
Global Team Manager, Data Management, Covance CLS AsiaPacific
Good Clinical Data Management Practice (GCDMP) and Global
Industry Guidelines on Data Integrity
Jessie CHEN
Head of Clinical Trial Management, Prizer China
SCDM BOT China Representative
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2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
TUESDAY, 17 MAY | WEDNESDAY, 18 MAY
High Quality of Clinical Data under Quality Assurance System
Haiyan LI, MD
Professor of Cardiology
Director, Drug Clinical Trial Center
Peking University Third Hospital
Session 0606 | Wednesday, 18 May
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THEME 6
In this session, invited speakers from the agencies and the industry
will talk about the submission data standard requirements from
US FDA, Japan PMDA and EU EMA, including the history, the
status and the plan for next few years. Invited speaker from China
CFDA CDE will also share the perspective of Chinese submission
data standard plan.
10:30–12:00 | 3rd Floor, 303A
History of US FDA Study Data e-Submission and CDISC
Standards
DATA QUALITY AND INTEGRITY - PART 2: GLOBAL DATA
INTEGRITY VS. CFDA DATA SELF–ASSESSMENT
SESSION CHAIR
Henry WU
Chief Executive Officer, FMD K&L, USA
Daniel LIU, PhD
Chief Scientific Officer, Beijing Clinical Service Center
History of Japan PMDA’s Study Data e-Submission and CDISC
Standards
Quality and integrity of clinical trial data is a basis of trial
analyses and relevant outcomes.
According to global data
integrity standard, any untrue, noncompliant, inconsistent,
incomplete and fake data and data documentation will result in
the null analyses and unreliable outcomes of clinical trials as well
as a worse faith and creditworthiness on sponsors and sites that
were performing and generating data and data documentation.
The regulatory submission from these unintegrities of data is
for sure to be rejected worldwide. This session will focus on
general principle and components of data integrity and share
the policy, procedures, experiences and lessons learned from
regulators, data management and QA practice. At the panel
discussion, the invited presenters will have an interaction with
attendees to further discuss the rationale and practice of CFDA
data self–assessment expectations in views of GCP data integrity
standpoints.
Data Quality & Integrity Experience Sharing from USFDA’s
Perspective
Chiang SYIN, PhD
Associate Country Director, FDA China Office
Current Strategy/Policy and Expected Practices for Trial Data
Integrity
Daniel LIU, PhD
Chief Scientific Officer, Beijing Clinical Service Center
Impact of Data Quality to a Global Submission—a Case Study
and Lesson Learned
Jerry WANG, PhD
Head of Global Biostatistics & Epidemiology China, R&D Beijing
Hub, Merck China
Panel Discussion
All Speakers from Session 0605 & 0606
Session 0607-1 | Wednesday, 18 May
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13:30–15:00 | 3rd Floor, 303A
GLOBAL REQUIREMENTS OF SUBMISSION DATA STANDARDS:
PAST, CURRENT AND FUTURE
SESSION CO-CHAIRS
Zibao ZHANG, PhD
Associate Director, Biostatistics and Programming, Biostatistics,
PPD
Yazhong DENG, MBA
Head of Clinical Data Analysis and Reporting Organization
(CDARO), Covance
Dehong CAO
Reporting and Mapping Manger, MSD R&D (China) Co.Ltd
Overview of China Submission Data Standard Proposal from
C3C/WG
John WANG
Manager, SAS Programming, Johnson & Johnson China, Ltd
Session 0607–2 | Wednesday, 18 May
Simultaneous
Translation
13:30–15:00 | 3rd Floor, 305
PHARMACEUTICAL BIOSTATISTICS GROUP OPERATING
MODELS IN CHINA – WHAT THE MULTINATIONAL PHARMA
COMPANIES HAVE LEARNED IN THE LAST SEVEN YEARS
SESSION CHAIR
Ouhong WANG, PhD
Director, Biostatistics, Amgen
The inaugural DIA China conference in 2009 called for
the establishment of a strong local biostatistics group for
multinational pharma companies operating in China. At the same
time, China has emerged to become an important health care
market with an increasing need for more and better medicines for
the Chinese patients, and hence the need for stronger presence
of drug development capabilities in China. Both internal and
external factors have been strong at work since then, and the
industry answered that call. Both the companies and the China
drug development macro–environment have benefited from the
scientific rigor brought on by the local statistical expertise. The
results speak for themselves, but the way to achieve the results
vary from company to company. Now, seven years later, it’s about
time to examine these different operating models and learn what
has worked well and what can be improved, in a “show–and–
tell” session. Different operating models and organizational
philosophies will be presented by various companies, followed
by a panel discussion on the unique characteristics of these
models, and possible future organizational trends. We hope
to develop a better understanding on how to best operate in
this environment, considering that we are part of the global
biostatistics organization. The outcome will be a good reference
on organizational design specifically for statisticians.
The Lilly Model
Chao ZHU, PhD
Head of Biostatistics, Asia-Pacific Statistical Sciences-China
Eli Lilly and Company
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
TUESDAY, 17 MAY | WEDNESDAY, 18 MAY
Pharmaceutical Biostatistics Group Operating Models in China What the Multinational Pharma Companies Have Learned in the
Last Seven Years
Liansheng ZHU, PhD
Head of Biostatistics, Neuroscience and Ophthalmology
Novartis China
The Roche Model
Nicole F. LI, PhD
Director, Biostatistics, AP Site Head of Biostatistics
Roche PDY, Shanghai
The Boehringer–Ingelheim Model
Luyan DAI, PhD
Head of Statistics China, Biostatistics & Data Sciences Asia,
Boehringer–Ingelheim
Panel Discussion
All Speakers Above and Invited Panelists:
Tony GUO, PhD
Director, Biostatistics, MSD R&D(China) Co., Ltd.
Roger QU, PhD
Head of Clinical Statistics, Pfizer R&D Center, China
Qi JIANG, PhD
Executive Director, Global Biostatistical Science, Amgen,
California, USA
James REIMANN, PhD
Vice President, Global Head of Oncology Biostatistics
Genentech, a Member of the Roche Group
Session 0608 | Wednesday, 18 May
15:30–17:30 | 3rd Floor, 303A
NURTURING STATISTICAL MINDSET IN DATA MANAGEMENT
FOR QUALITY IMPROVEMENT
SESSION CHAIR
Wei ZHANG, PhD
Vice President, Head of Biostatistics & Data Sciences Asia,
Boehringer Ingelheim (China) Investment CO., Ltd.
With the increasing complexity of clinical trial, while the need to
work smarter, acquiring knowledge from other functions into data
managers are becoming more and more urgent and important.
Fraudulent data is the worst quality of data. Biostatistician
and Programmer experts are going to share how statistical
methodology could be applied to detect fraudulent data. Missing
data is always a major problem in the analysis of clinical trials.
This time, we are focusing more on the potential protocol design
considerations to prevent or mitigate ‘missing data issue’; real
case will be shared in terms of how to monitor the missing data
issue and how to work together with study team to action on it.
Traditional data quality check performed by edit check validation
to target on specific data issue is still a main stream of CDM’s
practice, but with statistical visualization to identify the data
trends/issues is becoming more and more useful and important
to help team work smarter, CDM experts from top pharmas will
share their knowledge and some tools of this aspect. At the end
of the session, we are hoping the audience can get the taste of
how statistical mindset to be applied from protocol design to
conduct phase to help with data quality improvement, mostly
importantly to inspire you to think about wider application in real
work to help team work more efficient and smarter.
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THEME 6 | THEME 7
Fraudulent Data Detection
Luyan DAI, PhD
Head of Statistics China, Biostatistics & Data Sciences Asia,
Boehringer–Ingelheim
Jingwei GAO
Senior Director, Head of Statistical Programming Asia ,
Boehringer Ingelheim (China) Investment CO., Ltd
The Prevention of Missing Data in Clinical Trials
Jielai XIA, PhD
Professor, Director, Department of Statistics, the Fourth Military
Medical University
Data Visionary in Data Management
Charlin QI
Manager, CDM Asia Pacific Site Lead
Roche (China) Holding Ltd.
Theme
7
CMC & Generic Drug
Session 0701 | Tuesday, 17 May
Simultaneous
Translation
08:30–10:00 | 3rd Floor, 302A
BUNDLING REVIEW AND APPROVAL OF PACKAGING
COMPONENTS AND PHARMACEUTICAL EXCIPIENTS
SESSION CO–CHAIRS
Zero WU
Associate Regulatory Affairs Director, Eli Lilly
Fanny LIANG
Asia Pacific Regulatory Affairs Lead,
GE Healthcare (shanghai) Co., Ltd.
Bundling Review and Approval, the new approach to supervise
packaging components and pharmaceutical excipients, even it
was considered as the counterpart of Drug Master File, more
expectations and considerations were being discussed as one of
the most hot topics between the authority and industry in the
past years. This session is to share the prospective from the both,
and to bridge the communication accordingly between China
industry and global industry.
Regulatory Design and Challenges of Bundling Review &
Approval
Peng HAN
Associate Professor, Yeehong Business School, Shenyang
Pharmaceutical University
Development of US DMF Regulation and Experience Sharing
Jessica ZHENG
Regulatory Manager, Greater China
Life Science/Quality and Regulatory Management
Merck Chair of Industry Relationship Committee of IPEC China
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迎接法规变革,聚力专业质量
2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
TUESDAY, 17 MAY | WEDNESDAY, 18 MAY
Management of Excipient and Packaging Component Suppliers
Established by Pharmaceutical Companies
James CHEN
Head of Supplier Quality Management APAC, Global SQM,
Roche
Panel Discussion:
All Speakers Above and Invited Panelists:
Cloris TIAN
Regulatory Service Manager
Dow Chemical (China) Investment Company
Chair of IPEC China
Session 0702 | Tuesday, 17 May
Simultaneous
Translation
10:30–12:00 | 3rd Floor, 302A
INTERNATIONAL REGISTRATION OF GENERIC DRUG
SESSION CHAIR
Mingping ZHANG
Principal Consultant, PAREXEL Consulting
The China regulatory reform which initiate in 2015 is a significant
signal that China pharmaceutical development enter a new age;
under current regulatory environment, every pharmaceutical
company must develop high quality, which is qualify to enter
global major pharmaceutical market product, if the company
would like to survive. As a result, beside good science, global
regulatory understanding is another key for these companies. In
addition, the development investments will significant increase
with CFDA’s initiation to align with ICH country approval criteria.
The company must look for better return with more investment.
Consequently, the companies have to looking for global
registration. In this section, three speakers will provide regulatory
information regarding US, EU and south east Asia generic policy.
THEME 7
A product’s lifecycle covers the different stages of drug
development that includes discovery, pre-clinical and clinical
studies, marketing approval and post-approval manufacturing
changes. An integrated quality lifecycle management strategy is
crucial to a successful product development and maintenance
of product quality after approval for a biological product. With
the publication of ICH guidance documents Q8, Q9, Q10 and
Q11, and the re-organization of US FDA CDER’s Office of Product
Quality (OPQ), it is expected that the regulatory agency such
as FDA would apply the concept of lifecycle management with
integrated CMC-GMP reviews and risk-based quality assessment
for the development of biological products. The presentations
for this section will focus on the application of a quality lifecycle
management concept to changes in the manufacturing process
and the key regulatory considerations for a successful product
lifecycle management.
Introduction to Quality Life Cycle Management of Biological
Products
Duu-Gong WU, PhD
Member of US FDA Alumni Association
Director, Global Regulatory Consulting/Senior Consultant,
Pharmaceutical Product Development, USA
Regulatory Considerations for the Quality Lifecycle Management
of Biological Products
David LIN, PhD
Member of US FDA Alumni Association
Senior Consultant, Biologics Consulting Group, USA
GMP Perspectives on Lifecycle Management of Biological
Products
Chiang SYIN, PhD
Associate Country Director, US FDA China Office
US ANDA submission and approval – CMC & GMP
Panel Discussion
All Speakers Above
Siegfried SCHMITT, PhD
Principal Consultant, PAREXEL International, UK
Session 0704 Tuesday, 17 May
EU Generic Registration Consideration
Juan WANG
Huahai Pharma
Regulatory Consideration for generic drug registration in
Malaysia, Philippines and Thailand
Becky LU
Regional Director of APAC, Clinical Trial Regulatory Service,
PAREXEL
Session 0703 Tuesday, 17 May
13:30–15:00 | 3rd Floor, 302A
LIFE–CYCLE MANAGEMENT OF BIOLOGICS
SESSION CO–CHAIRS
David LIN, PhD
Member of US FDA Alumni Association
Senior Consultant, Biologics Consulting Group, USA
Duu–Gong WU, PhD
Member of US FDA Alumni Association
Director, Global Regulatory Consulting/Senior Consultant,
Pharmaceutical Product Development, USA
15:30–17:30 | 3rd Floor, 302A
QUALITY CONSISTENCY OF GENERIC DRUG
SESSION CHAIR
Zengjiang CHENG, PhD
Chairman of the the Board
PharmaSea (Beijing) Pharmaceutical Tech. Co., Ltd.
Generic drug quality consistency evaluation has become one
of the most important initiatives in pharmaceutical industry of
China. The speakers of this session will share their insights on
generic consistency evaluations that were carried out in EU,
US, and Japan and the new development of the topic. The key
study areas in pharmaceutical science that should be covered
in generic quality consistency evaluation will be discussed, so
companies can effectively conduct needed development work in
the most efficient way. Furthermore, a detailed comparison of
the drug review and administration by FDA and CFDA, especially
for the generic drugs, will be presented at the session.
Research on Generic Drug Quality Consistency Evaluation and Its
Development
Bo ZHU
Director, Pricing & Market Access
R&D-Based Pharmaceutical Association Committee( RDPAC)
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
TUESDAY, 17 MAY | WEDNESDAY, 18 MAY
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THEME 7
Analysis of the Key Areas in Pharmaceutical Science for Generic
Drug Quality Consistency Evaluation
Implementing Public Standard in the Drug Registration:
Industry’s Perspective
Lichun ZHOU
Assistant Chief, Beijing Institute for Drug Control
Andrew CHANG, PhD
Vice President, Quality and Regulatory Compliance,
Product Supply Quality, Novo Nordisk, USA
Generic Drug Consistency Evaluation and Comparison of Drug
Review and Administration between China and US
Jifeng LEI
President, General Manger, Shanghai Anbison Lab. Co., Ltd
Chairman, International Society For Pharmaceutical Engineering
(ISPE)
Session 0705 & 0706 | Wednesday, 18 May
Simultaneous
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Panel Discussion
All Speakers Above and Invited Panelist
Adrian EVANS
Principal Pharmacopoeial Scientist, Medicines and Healthcare
Product Regulatory Agency (MHRA), British Pharmacopeia, UK
Session 0707 | Wednesday, 18 May
08:30–12:00 | 3rd Floor, 302A
13:30–15:00 | 3rd Floor, 302A
ROLE OF PUBLIC STANDARD IN THE DRUG REGISTRATION PART 1 & PART 2
SESSION CO-CHAIRS
BIOEQUIVALENCE STUDY OF GENERIC DRUG
SESSION CHAIR
Wendy YU
Regulatory Affair Director, Regulatory Affair, MSD R&D (China)
Co., Ltd
Melly LIN
Senior Regulatory Manager, CMC Policy, Roche (China) Holding
Ltd.
How to continuously improve pharmaceutical product quality
has been the common theme between regulatory agency and
pharmaceutical industry. As the national standard, Chinese
pharmacopeia placed a very important role in China drug
development, registration and quality control. In the past year,
the Chinese Pharmacopeia 2015 version had been officially
published, the new version shows more scientific base in the
monograph and general chapter development, meanwhile ,it also
bring challenge to industry and regulatory agency in the process
of implementation. In this session, we will invite experts from
different area such as the Chinese Pharmacopeia committee,
British pharmacopeia; Center of drug evaluation of CFDA,
Institute of Drug control and pharmaceutical companies, who will
discuss and provide deep insight on the role of pharmacopeia in
drug registration, and product quality improvement.
Chinese Pharmacopeia’s Vision in 2020
Wei ZHANG
General Secretary, Chinese Pharmacopeia
Topic TBD
CFDA Speaker Invited
The Challenges in the Process of Pharmacopoeia Execution
Zhijian WANG
Vice General Director,
Zhejiang Institute for Food and Drug Control
The Role and Benefits of the Pharmacopoeia to Regulation
Samantha ATKINSON, PhD
Scientific Director, British Pharmacopoeia Commission and
Deputy Director, Inspection, Enforcement & Standards Division,
Medicines and Healthcare Products Regulatory Agency, UK
Jin YANG, PhD
Professor, China Pharmaceutical University
Bioequivalence Requirement in China
CFDA Speaker Invited
The Key Considerations for Bioequivalence Study
Jin YANG, PhD
Professor, China Pharmaceutical University
Using BE Strategies in Generic Drug
Huichen LIU, MD, PhD
Vice Director, GCP Center, National Aerospace Center Hospital
Session 0708 | Wednesday, 18 May
15:30–17:30 | 3rd Floor, 302A
BIOWAIVER: IN–VITRO DISSOLUTION
SESSION CHAIR
Fred LI, PhD
Vice President, Pharma R&D, Hua Medicine (Shanghai) Ltd.
From FDA Guideline on Waiver of In Vivo Bioavailability
and Bioequivalence Studies to CFDA issued Generic Drug
Bioequivalence Studies recently, Bioequivalence (BE) becomes
the topical subject of the generic research & development,
especially oral dosage. The strategy will be designed with the
more understanding of the compound biopharmaceutical
behavior, preformulation profile, IVIVC and CQA etc.
Biowaiver Request Based on Dissolution Profile
Donghao LU, MD, PhD
President, Reg-Strategy, USA
Quality Consistency Evaluation Strategy for Oral ControlledRelease Liquid
Dezhi ZHU
Director, Research & Development, CoSci Med-Tech Co.,Ltd.
Improvement Strategy of OSD
Shifeng WEI
General Manager, Innovaco Pharmaceuticals, Inc.
迎接法规变革,聚力专业质量
2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
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TUESDAY, 17 MAY | WEDNESDAY, 18 MAY
THEME 7 | THEME 8
Session 0802 | Tuesday, 17 May
Theme
8
Simultaneous
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10:30–12:00 | 3rd Floor, 303B
Biologics & Biosimilar
Session 0801 | Tuesday, 17 May
DEVELOPMENT OF BIOSIMILARS: TECHNICAL ASPECTS
SESSION CHAIR
Jiali LUO, PhD
Boehringer Ingelheim
Simultaneous
Translation
08:30–10:00 | 3rd Floor, 303B
RECENT TRENDS IN THE REGULATION OF
BIOPHARMACEUTICAL PRODUCTS
SESSION CO-CHAIRS
Janet LV
Head of Regulatory, Asia Pacific, Roche
Joe ZHANG, MD, PhD
Executive Deputy Head, Center of Medicinal and Translational
Sciences, Shanghai CP Guojian Pharmaceuticals CO. Ltd
Because of biopharmaceuticals’ unique advantages in disease
treatment and a rapid growth in technologies related to such
products, development of biopharmaceutical products has
become a hot area in pharmaceutical R&D. In order to help a
healthy growth of this sector, regulatory agencies from different
countries have issued a series of guidelines including guidelines
on biosimilars in recent years. In this session, experts from CFDA,
US FDA, Health Canada and pharmaceutical industry will share
their view on recent trends in regulations of biopharmaceuticals.
Recent Trends in the Regulation of Biopharmaceutical Products from Health Canada Perspective
Jian WANG, MD, PhD
Chief, Clinical Evaluation Division - Haematology/
Oncology, Centre for Evaluation of Radiopharmaceuticals &
BiotherapeuticsBiologics and Genetic Therapies Directorate
HPFB, Health Canada
FDA Perspective: Recent Trends in the Regulation of
Biopharmaceuticals
Joel WELCH, PhD
Team Leader, Office of Pharmaceutical Quality, Office of
Biotechnology Products, Division of Biotechnology Review and
Research II, CDER, FDA, USA
Recent Trends in the Regulation of Biopharmaceutical Products
– An IFPMA Perspective
Thomas SCHREITMUELLER, MD, PhD
Head Regulatory Policy, Pharma Technical Regulatory
F. Hoffmann-La Roche, Ltd., Switerland
Panel Discussion:
All Speakers Above and Invited Panelist:
Raffaella Balocco MATTAVELLI, PhD
INN Group Lead, Regulation of Medicines and Other Health
Technologies, Essential Medicines and Health Products, World
Health Organization
Regulatory Expectation on the Analytical Comparison Study of
Biosimilar
CDE Speaker Invited
Consideration in the Analytical Similarity Assessment of
Biosimilar
Joel WELCH, PhD
Team Leader, Office of Pharmaceutical Quality, Office of
Biotechnology Products, Division of Biotechnology Review and
Research II, CDER, FDA, USA
Case Study on Biosimilar CMC Development
Nick CECIL
Vice President, PAREXEL
Session 0805 & 0806 | Wednesday, 18 May
Simultaneous
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08:30–12:00 | 3rd Floor, 303B
CLINICAL TRIAL DESIGN OF BIOSIMILAR – PART 1 & PART 2
SESSION CO-CHAIRS
Lan QIN, MD, PhD
Senior Manager, Medical Science
Shanghai Roche Pharmaceuticals Ltd.
Nick CECIL
Vice President, PAREXEL
With the rapid development of bio-technology and patent cliff
of many originator biologics, biosimilars development is drawing
market’s attention globally. However, due to the complexity
of biological therapies, biosimilars cannot be identical with
the originators. Evaluation principles of “chemical generics”
do not apply to biosimilars. Many countries have developed
biosimilars development guidelines. With a view to guiding and
standardizing the development and evaluation of biosimilars
and promoting the healthy development of biopharmaceutical
industry, the CFDA promulgated Guidelines on Development
and Evaluation of Biosimilars (for trial implementation), which
prescribes relevant registration requirements including the
application procedures, registration categories and application
materials of biosimilars. In this session, we will hear the regulatory
expectation on the clinical design of biosimilar from experts
of CDE and Health Canada. The speaker from FDA will also
introduce the statistical consideration of the clinical trial design.
In addition, the speaker from PharmaBio and clinical expert will
discuss about the key considerations of clinical development and
the endpoint selection for biosimilar development in Lymphoma.
We will also have the experts’ panel discussion for hot topics in
the clinical trial design.
Regulatory Expectation on the Clinical Design of Biosimilar
Chenyan GAO
Acting Director, Office of Clinical Department I, Center for Drug
Evaluation, CFDA
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
TUESDAY, 17 MAY | WEDNESDAY, 18 MAY
Demonstration of Biosimilarity: Sensitive Clinical Study
Population and Endpoint
Jian WANG, MD, PhD
Chief, Clinical Evaluation Division - Haematology/
Oncology, Centre for Evaluation of Radiopharmaceuticals &
BiotherapeuticsBiologics and Genetic Therapies Directorate
HPFB, Health Canada
Challenges for CD20 Biosimilars Clinical Development in BNHL:
Global Perspective
Coiffier BERTRAND, MD, PhD
Professor of Hematology, Department of Lymphoma/Myeloma,
University of Claude Bernard, Lyon, France
Statistical Consideration of the Clinical Trial Design of Biosimilar
Lei NIE, PhD
Team Leader, Division of Biometrics V, Office of Biometrics/
Office of Translational Sciences, CDER, FDA, USA
Key Considerations of Clinical Development of Biosimilars
Hoss DOWLAT, PhD
Vice President, Regulatory Affairs EU–USA, PharmaBio
Consulting (Life Sciences), Germany
THEME 8
should be distinct from each other through BQ. The WHO BQ
guideline is an important step toward global harmonization
on biological name. If adopted by global regulatory agencies,
it could help facilitate the global pharmacovigilance. CFDA has
started to initiate the biosimilar naming since the beginning of
2015 when the biosimilar guideline was published. In this session,
we will invite the experts from WHO INN committee, Chinese
Pharmacopeia Committee, ADR center and some top physician
to discuss about the biological naming.
INN-International Nonproprietary Names Nomenclature for
Biologicals
Raffaella Balocco MATTAVELLI, PhD
INN Group Lead, Regulation of Medicines and Other Health
Technologies, Essential Medicines and Health Products, World
Health Organization
Considerations on Generic Naming of Therapeutic Biologics in
China
Zhongping GUO
Division Chief, Division of Biologics, Chinese Pharmacopeia
Commission
Current Situation on Post Approval AE Monitoring for Biologicals
in China
Panel Discussion
All Speakers from Session 0805 & 0806 and Invited Panelists
Binghe XU, MD, PhD
Professor and Director, Department of Medical Oncology,
the Cancer Hospital and Institute, Chinese Academy of Medical
Sciences (CAMS) and Peking Union Medical College (PUMC)
Jielai XIA, PhD
Professor, Director, Department of Medical Statistics,
4th Military Medical University
Chunhua TIAN
Division Chief, Division of Essential Drugs Monitoring and
Evaluation Center for Drug Reevaluation, National Center for
ADR Monitoring, CFDA
Considerations on Biosimilar Naming - From Clinical Perspective
Yuqin SONG, Professor
Vice Director, Department of Lymphoma, Peking University
Cancer Hospital
Session 0808 | Wednesday, 18 May
Partha ROY, PhD
Director, PAREXEL Consulting
Session 0807 | Wednesday, 18 May
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15:30–17:30 | 3rd Floor, 303B
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13:30–15:00 | 3rd Floor, 303B
NAMING AND PHARMACOVIGILANCE FOR BIOLOGICS
SESSION CO-CHAIRS
Joy LI, MD, PhD, MBA
Global Head, J&S (Shanghai) Co., Ltd.
Melly LIN
Senior Regulatory Manager,
CMC Policy, Roche (China) Holding Ltd.
To address the accessibility of biologics, WHO and many
regulatory agencies have established the regulatory pathway
and technical guideline for biosimilar. Considering that some
rare adverse reaction may not be detected due to limited clinical
experience of biosimilar pre-authorization, many regulatory
agencies think that implementation of the abbreviated approval
pathway for biosimilar adds to the need for collection and analysis
of safety data after approval through effective post-approval
safety surveillance systems that accurately track and trace
all biologics from the patient to the manufacturer. Successful
pharmacovigilance depends on the accurate identification
of suspect drug when reporting AE. Therefore it has become
a hot topic globally regarding how to assign proper name for
biosimilar, especially on whether biosimilar should have distinct
name to its reference product. WHO published a draft guideline
on Biological Qualifier (BQ) in 2015 which requiring all biologicals
CUTTING EDGE TECHNOLOGIES IN BIOLOGICS DEVELOPMENT
SESSION CHAIR
Joe ZHANG, MD, PhD
Executive Deputy Head, Center of Medicinal and Translational
Sciences, Shanghai CP Guojian Pharmaceuticals CO. Ltd.
New technologies used in discovery and development of
biologics have enable scientists to create a variety of innovative
biopharmaceuticals in treatment of difficult diseases such as
cancer. This session will invite senior experts from academia and
pharmaceutical industry to discuss the cutting edge technologies
used in preclinical and clinical development of biologics with a
focus on bi-specific antibodies.
Novel Formats of Bispecific Antibodies
John WANG, PhD
Professor, School of Pharmaceutical Sciences,
Sun Yat-Sen University
Biologics: Past, Present and Future
Dennis Anthony WONG, MD
Associate Vice President, Head of Development, Asia Pacific
R&D, Sanofi (China) Investment Co., Ltd. Shanghai Branch
Control Strategy of Bispecific Antibody
Hongbin LIU, PhD
Senior Scientist, Protein Analytical Chemistry, Genentech, Inc.
迎接法规变革,聚力专业质量
2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
76
TUESDAY, 17 MAY | WEDNESDAY, 18 MAY
THEME 9
TFDA GCP Inspection Program: Current and Future
Theme
9
Mei–Chen HUANG
Specialist, Division of Medicinal Products
TFDA
Quality System
FDA’s Inspection on Quality and Compliance – Inspector’s
Expectations
Chiang SYIN, PhD
Associate Country Director, FDA China Office
Session 0901 | Tuesday, 17 May
08:30–10:00 | 3rd Floor, 306B
China CFDA Inspection Initiatives and Efforts
HOW TO IMPROVE THE ETHICS REVIEW QUALITY
SESSION CHAIR
Xiuqin WANG, PhD
Deputy Director, Department of Science and Technology,
Jiangsu Province Hospital, First Affiliated Hospital with Nanjing
Medical University
Jianan WANG
Inspector, Office of Inspection I, Center for Food and Drug
Inspection, CFDA
Session 0905 | Wednesday, 18 May
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08:30–10:00 | 3rd Floor, 306B
Topic TBD
CFDA Speaker Invited
How to Build a High Quality IRB and Human Research Protection
Program
Jun ZHAO
Professor, Vice President, Jiangsu Province Hospital
Helen LI, MD, MBA
Asia Lead, PCO/DSU Audit, Pfizer Medical Quality Assurance
How do we transform quality science from reactively respond to
audit findings to proactively building up a robust and effective
quality management system (QMS)?
Quality IRB: Sponsor’s Perspective & Expectation
Heidi LIU, MD
Quality Assurance Professional, Pfizer
Session 0902 | Tuesday, 17 May
TRANSFORM QUALITY SCIENCE FROM REACTIVE TO
PROACTIVE
SESSION CHAIR
Simultaneous
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10:30–12:00 | 3rd Floor, 306B
INSPECTIONS ON QUALITY AND COMPLIANCE – WHAT ARE
INSPECTORS’ EXPECTATIONS
SESSION CO-CHAIRS
Jun LI
Inspection Manager, APAC Head, Johnson & Johnson
Helen LI, MD, MBA
Asia Lead, PCO/DSU Audit, Pfizer Medical Quality Assurance
In this session, inspectors from USFDA, TFDA as well as CFDA
are invited to talk about their national GxP inspection programs
and share their inspection experiences. A 30–minute panel
discussion is to be organized where the invited speakers will
answer any questions which interest the audience, as well as
commenting on the current hot topics. Discussions could also be
about inspectors’ expectations/perceptions in the next few years
regarding regulations and inspections.
At this session, we will illustrate industry effort, individually and
collectively, in ensuring quality via effective Quality Management
System. TransCelerate will share with us how pharmaceutical
companies collaboratively work together on QMS, and its
missions and some initiatives. We also will share one sponsor’s
experience of measuring effectiveness via Clinical QMS metrics.
Last but not least, we will explain new requirements in the ICH
E6 addendum for risk–based approaches to managing clinical
trials, the expected implications with focus on sponsor vendor
oversight and share necessary steps and tools that should be in
place for adequate vendor oversight.
TransCelerate Quality Management System Initiative Update
Ann Meeker-O”CONNELL
Head, Risk Management and External Engagement, BioResearch
Quality & Compliance, Johnson&Johnson
Pfizer Clinical QMS: Metrics and Effectiveness
Carol BYE
Vice President, Medical Quality Assurance, Pfizer UK
ICH E6 New Addendum and its Requirements for Vendor
Oversight
Peter SCHIEMANN, PhD
Managing Partner, Widler & Schiemann Ltd., Switzerland
2016 Quantitative Science Forum
August 14-15 | Beijing Xinjiang Plaza
http://en16957.eventdove.com/
Contact: Runshan Chen | Tel: +86. 10. 57042653
Email: [email protected]
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
TUESDAY, 17 MAY | WEDNESDAY, 18 MAY
Theme
10
Pharmacovigilance
Session 1001 | Tuesday, 17 May
Simultaneous
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08:30–10:00 | 3rd Floor, 301B
INNOVATION AND INITIATIVES OF PHARMACOVIGILANCE
OPERATION IN CHINA
SESSION CO–CHAIRS
Yuan YAO
Head of Drug Safety, Merck China
Echo LI
Pharmacovigilance Associate Director
Astellas Pharma China, Inc.
Medicinal product safety makes headlines every day and is one
of the hot spots of public concern. Health authorities (including
CFDA) continuously strengthen regulatory requirements on
pharmacovigilance. With the fast development of information
technology and arrival of Big Data Era in China, we would like to
explore the opportunities of Pharmacovigilance in this context. In
this session, we bring the insights from experts from CFDA, FDA
and Industry. The diversified perspective will initiate our thinking
and action.
77
THEME 10
will discuss the application of real-world data in post-marketing
safety including the advantages and limitations. Last but not
least, we will discuss the completeness and accuracy of each
adverse event, which is an essential component to the success
of pharmacovigilance, and the key elements of a high quality
post marketing safety database. The invited speakers will share
their experience and perspectives on the proposed topics, and
will engage in interactive discussions with everyone who attends
this session.
Risk Identification and Management– Experience from Japan
Edward Stewart GEARY, MD
Senior Vice President, Chief Medical Officer, Corporate Medical
Affairs, Eisai, Japan
Role of Real World Data in Establishing Safety Profile of a Newly
Marketed Drug Product
Siyan ZHAN, PhD
Professor, Deputy Director, Centre for EBM and Clinical Research
Deputy Director, Department of Epidemiology and Biostatistics
Director, Center of Postmarketing Safety Evaluation, Peking
University
Safety Data Quality – a Key to Post Authorization Safety
Surveillance
Howe LI, MD
Chief Medical Officer, Tigermed Consulting CO., LTD
Session 1003 | Tuesday, 17 May
13:30–15:00 | 3rd Floor, 301B
Prospects of China Pharmacovigilance in the Big Data Era
Chunhua TIAN
Division Chief, Division of Essential Drugs Monitoring and
Evaluation Center for Drug Reevaluation, National Center for
ADR Monitoring, CFDA
DATA–DRIVEN DECISION MAKING
SESSION CO–CHAIRS
Big Data on Pharmacovigilance
Gerald DAL PAN, MD
Director, Office of Surveillance and Epidemiology, CDER, FDA,
USA
Xiujing KOU
Safety Science Leader, Global Safety Risk Management,
Roche (China) Holding Ltd.
Significance of Big Data for Pharmacovigilance in Enterprises
Daniel YANG, MD, PhD
President, G2 BioPharma Services
Session 1002 | Tuesday, 17 May
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10:30–12:00 | 3rd Floor, 301B
PHARMACOVIGILANCE IN A NEW ERA – HOT TOPICS
SESSION CO–CHAIRS
Miranda WANG
China PV Head, BMS
Vera LIANG
Senior Director, Disease Area Cluster Leader Generics, Shanghai
Site Head, Safety Surveillance and Risk Management, Pfizer
The pharmacovigilance discipline continues to evolve rapidly in
the context of increasing attention to patient safety. A number of
‘hot topics’ are currently being addressed, by the pharmaceutical
industry, academia and Heath Authorities around the globe.
As such three topics will be discussed in this session. Firstly,
the key elements for a successful Risk Management System
with particular consideration on ethnicity (e.g. Asian) in risk
characterization and the role of the state healthcare system in
the implementation of risk management tools. Secondly, we
Simultaneous
Translation
Lawrence Mason SHIH
PDSAP Site Head, Safety Science in Asia Pacific,
Roche (China) Holding Ltd.
Safety data from clinical trials, spontaneous reports, literature,
and other sources has a tendency to increase over time. Making
the most efficient use of the data available using integrated
safety databases, data visualization tools, and focusing on
the right data is critical for enabling timely decisions that are
informed by the best analysis possible. This session will focus on
various aspects of safety data as it pertains to making decisions.
A New Safety Analysis Paradigm with Data Visualization
Josephine FONG
Master Biostatistics, Scientific Enablement Leader, PV and
Scientific Development, Roche
Integrated Safety Database, Do you Need One?
Lawrence Mason SHIH
PDSAP Site Head, Safety Science in Asia Pacific,
Roche (China) Holding Ltd.
Safety Data Driven Decision Making & RMP - An Example in the
Japanese Pharma Industry
Junichi IMAGAWA, PhD
Local PV Head, Drug Safety Division,
Chugai Pharmaceutical Co., Ltd., Japan
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迎接法规变革,聚力专业质量
2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
TUESDAY, 17 MAY | WEDNESDAY, 18 MAY
Session 1004 | Tuesday, 17 May
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15:30–17:30 | 3rd Floor, 301B
EFFECTIVE AND TIMELY RISK COMMUNICATION
SESSION CHAIR
Gao GAO
Associate Director, Safety Surveillance and Risk Management,
Pfizer China Research and Development
Risk communication is an integral part of risk management for
medicinal products and has received increased attention over
the past few years as systems have become more complex and
information more rapid. It is challenging but necessary to convey
balanced and accurate information about benefit and risk to all
stakeholders. Risk communication tools need to be audience
oriented. Effective and timely communication not only facilitates
decision making by regulatory agencies and pharmaceutical
companies but also helps ensure healthcare professionals and
patients make informed therapeutic choices. Three drug safety
experts will introduce and discuss the role of risk communication,
communication tools, regulatory expectations, global initiatives
and scientific updates.
Risk Communication –Scanning the Landscape: Updates and
Challenges
Brian EDWARDS, MD
Principal Consultant, Pharmacovigilance & Drug Safety,
NDA Regulatory Science Ltd.
Effective Benefit Risk Communication in the US – Learning from
the Past Decade from the Pharmacoepidemiology Perspective
Jasmanda WU, PhD, MPH
Senior Director, Global Pharmacovigilance & Epidemiology,
Sanofi
Emergency Management and Risk Communication for Medicinal
Products
Yue YANG, PhD
Professor, Shenyang Pharmaceutical University
2nd DIA China
Drug Discovery Innovation
Conference
October 24-26, 2016
Suzhou
Featured Themes
• Target Selection
• Compound Identification/
Optimization to Compound
Nomination
• IND Enabling and Dossier Preparation/
Filing
• FIH to POC
• BD & Partnership
Content and speaking opportunities, please contact:
Ms. Kathy Yuan | email: [email protected]
Tel: +86 21 6057 7239
THEME 10 | THEME 11
Theme
11
Necessary Elements in Successful
Drug Development Activities
Session 1105 | Wednesday, 18 May
08:30–10:00 | 3rd Floor, 306A
INHERITING AND INNOVATION: HOW MEDICAL WRITERS
WORKING IN GLOBAL PHARMACEUTICAL COMPANIES
SUPPORT REGULATORY REQUIREMENTS FROM DIFFERENT
AUTHORITIES
SESSION CHAIR
Nan WANG, PhD
Senior Scientific Medical Writer, China Site lead, Global Medical
Writing, Bayer
Medical writing was originally established in the western countries.
In the past 10 years, the development of medical writing in China
is fast and local expertise is establishing. With the dynamic
environment, how to provide an efficient and flexible medical
writing service to support the dossier preparation particular
for China without compromising the consistency with global
message is a hot topic. In addition, MW’s role is evolving with
increased legislation on transparency in many countries. Their
job does not end when submission documents are prepared.
This session will discuss clinical document development for
China NDA submission with a focus on the content strategy
and process plan in order to support the efficient and smooth
submission. In addition, the new EU regulation on disclosure of
submission documents will be shared and its impact on medical
writer’s daily work will be discussed.
How to Effectively Develop Clinical Documents in the EU/US and
China NDA Dossier
Julia COOPER, PhD
Vice President, Head of Global Medical Writing Services,
PAREXEL International
How to Make a Good Plan for Clinical Documents Development
in China NDA Dossier
Tammy WU, PhD
Senior Scientific Communication Manager, Medical, Lilly Suzhou
Pharmaceutical Co. Ltd. Shanghai Branch
Overview on Trial Data Disclosure Requirements with Special
Focus on the New EU Regulation Policy 70
Florence BERGER, PharmD
Global Head, Clinical Documentation, Sanofi R&D
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
TUESDAY, 17 MAY | WEDNESDAY, 18 MAY
Session 1106 | Wednesday, 18 May
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THEME 11
Quality by Design – Strategic Input to Global Clinical
Development Plan
10:30–12:00 | 3rd Floor, 306A
HOW DOES MEDICAL WRITING SUPPORT CHINA LOCAL
COMPANY ON DRUG REGISTRATION ABROAD
SESSION CHAIR
Rui YANG, PhD
Associate Director, Head of Medical Writing Services AsiaPacific, PAREXEL International
Amid fast development of the pharmaceutical industry in
China, more and more China local pharmaceutical companies
are developing innovative and generic drugs and aiming for
marketing them overseas. Medical writing is a highly specialized
profession. Globally, the clinical documents for drug registration
are prepared by professional medical writers. But in China,
medical writing is still a rising profession. Due to the complexity
of regulatory requirement and language barriers, it could be a
big challenge for China local companies to develop submission
documents for drug registration in the US and/or EU. In many
cases, they seek services from a CRO for the development of
submission documents.
In the present session, we will discuss how medical writing
can support the development of clinical documents for drug
registration for both innovative and generic drugs, and how to
manage the document development if outsourced to a CRO.
Xiaohui GAO
Global Clinical Project Manager, Bayer Pharma R&D Centre
Beijing
Structured Risk-Management Tools – Performance Dashboard
Munching KAN, MD, PhD
Executive Director, Global Therapeutics
Covance Pty Ltd,Australia
Panel Discussion: Embrace environmental Challenges, Endeavor
High Quality Execution in China
All Speakers above and Invited Panelists
Jessie CHEN
Head of Clinical Trial Management, Prizer, China, SCDM BOT
China Representative
Isabel HAN
Director, Head of Operations, Covance
Judy ZHANG
Director, Clinical Operation for China Mainland, Hong Kong and
Taiwan, Clinical Operation, ICON Clinical Service
Lijun HAN
Senior Clinical Research Director, CMR Region China,
Novonordisk
Medical Writing in Supporting Small-Size Pharma’s Innovative
Drug Registration in the US
George GUO
Global Monitoring Operation Country Head , Novartis
Pharmaceuticals (China) Oncology
Cliff CHUNN
President, CD Chunn & Associates, Inc, USA
Session 1108 | Wednesday, 18 May
Medical Writing in Support of Generic Drug Registration and
Post-Marketing Requirements in the US
Roopa BASRUR
Senior Director, Medical Writing Services India,
PAREXEL International
15:30–17:30 | 3rd Floor, 306A
PROJECT RISK MANAGEMENT: DEALING WITH THE CERTAINTY
OF THE UNCERTAINTY
SESSION CHAIR
Yuan LI, MD
Director, Project Management, MSD China R&D
How to Select and Manage a High Performing Medical Writing
Service Provider
Helle-Mai GAWRYLEWSKI
Senior Director, Medical Affairs & Alliance Management,
Regulatory Medical Writing, Janssen Research & Development,
USA
Session 1107 | Wednesday, 18 May
Simultaneous
Translation
Simultaneous
Translation
13:30–15:00 | 3rd Floor, 306A
RISK-BASED PROJECT MANAGEMENT
SESSION CHAIR
Rebecca DAI
Vice President, Head of Clinical Project Management – Primary
Care & Women’s Healthcare, Bayer
The quality of clinical trial data was emphasized many time
during the recent CFDA reforms. The Clinical Project Manager
will be accountable for quality, compliance with regulations
and company procedures, resource requirement, timelines and
budgets for assigned clinical projects. This session is to explore
how a clinical project manager could contribute to the trial
quality.
Although a lot of things in a project may be well planned and
controlled, there are always unforeseen scenarios which may
bring the big uncertainties to the project such as the recent
reforms from CFDA, the emerging data, the evolving competitors
landscape etc. This session is aimed to explore as the project
manager how to do the project risk management when facing
the uncertainty.
The Basic Concepts of Project Risk Management and Common
Risks of Drug Development
Alexander KUHL, PhD
Head Project & Portfolio Management China, Prizer
A Risk Story Sharing
Wencheng XU
WuXi Clinical Development Services (Shanghai) Co., Ltd.
Panel Discussion
All Speakers Above and Invited Panelist:
Clara GU
Head of Global Project Management, General Medicine
Beijing Bayer Healthcare
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TUESDAY, 17 MAY | WEDNESDAY, 18 MAY
Theme
12
Medical Affairs
Session 1201 | Tuesday, 17 May
08:30–10:00 | 3rd Floor, 301A
MEDICAL AFFAIRS STRATEGIC TRANSFORMATION IN THE
NEW ERA - CHIEF MEDICAL OFFICERS DISCUSSION
SESSION CHAIR
James HE
Chief Medical Officer, Novartis China
In the last few years, there is paradigm shift in the pharmaceutical
industry to move from mass marketing to the personalized
medicine and patient-centric approach, medical affairs function
is taking more active role in driving business growth in closely
partnership with commercial functions.
This high-level panel discussion will discuss the strategic roles
of medical affairs function in the current challenging market and
what medical affairs will evolve in the near future.
Topics to be Covered:
1. The Strategic Vision of Medical Affairs in the New Era in
China
2. The Strategic Role of CMO in the Company
3. How Medical Team Can Take a More Active Role in When
Working with the Cross-Functional Team
4.How to Close the Gap between the Expectation to Medical
and the Medical Team’s Current Capability
5. How to Develop the Medical Talent Pipeline and Keep the
Team Stable and Performing
6.How to Deploy and Grow the Field Medical Functions
Invited Panelists:
Yiman ZHENG
Vice President, Medical Affairs, MSD China Holding Co.,Ltd
Zig LANG, MD, PhD
Medical Affairs and Pharmacovigillence
Vice President, Bayer Healthcare Company
Li WANG, MD, PhD
Vice President, Medical, Eli Lily & Company
Matthew TAN
Country Medical Director, Bristol-Myers Squibb China
Tianhong LUO
Head, Medical Affairs, Sanofi
Session 1202 | Tuesday, 17 May
10:30–12:00 | 3rd Floor, 301A
POST-MARKETING STUDIES IN THE NEW ERA OF PRECISION
MEDICINE
SESSION CHAIR
Li WANG, MD, PhD
Vice President, Medical, Eli Lily & Company
THEME 12
Post marketing studies, including phase IIIb/IV interventional
studies and observational studies etc., are the studies conducted
after product labels are approved by regulatory agencies, with
the objectives of supplementing important efficacy and safety
information in broader patient populations which may not be
able to collect during registration studies. Precise medicine is a
new concept of medicine integrated with biological technologies
and information technologies. The focus of our session is to
discuss how to design and conduct post marketing studies in the
era of precision medicine, in order to maximize patient benefits
and minimize risks of a product after its commercial launch.
Post Marketing Studies in the Era of Precise Medicine
Jie WANG, MD, PhD
Professor & Director, Cancer Hospital Chinese Academy of
Medical Sciences
Post Marketing Commitment Study in Treatment of NSCLC
Driven by Bio-Marker Testing
Liheng MA, MD, PhD
Senior Medical Affairs Therapeutic Area Manager, Medical
Affairs , OBU, Pfizer China
Quality, Value and Risk in Observational Research – Does it
Change in the Era of Precision Medicine?
Vivian CHENG
Director, Real World & Late Phase Research
Quintile
Session 1205 | Wednesday, 18 May
08:30–10:00 | 3rd Floor, 301A
THE ROLES AND WORKING MODELS OF FIELD MEDICAL
SCIENCE LIAISONS IN CHINA
SESSION CHAIR
Matthew TAN, MD
Country Medical Director, Bristol-Myers Squibb China
MSLs are increasingly playing an important role of
communicating scientific knowledge to the HCPs on behalf of
the biopharmaceutical industry in China. This session will be
focused on the discussion of the roles and working models of
MSLs in China.
The Working Model of MSLs in China
Eugen LI, MD
TA Head of Diabetes; Medical Affairs China Group I Director,
Clinical Development and Medical Affairs, Boehringer Ingelheim
The Value of MSLs to the Business
Eileen LONG, MD
BU Head, Sanofi
The Management and Development of MSLs
Min HOU
Associate Manager, Medical Affairs, Roche
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
TUESDAY, 17 MAY | WEDNESDAY, 18 MAY
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THEME 12
Session 1206 | Wednesday, 18 May
Innovation Leads Medical Communication New Model
10:30–12:00 | 3rd Floor, 301A
Xuhui WANG
Associate Director, Medical Information, Pfizer
THE WORKING MODEL OF MEDICAL AND COMMERCIAL
FUNCTIONS IN THE PATIENT-CENTRIC HEALTHCARE
ENVIRONMENT
SESSION CHAIRS
Zig LANG, MD, PhD
Medical Affairs and Pharmacovigillence Vice President, Bayer
Healthcare Company
The session will focus on the continuing evolution of medical
and commercial working model in this competitive market with
requirement for business growth and scientific leadership. The
broad perspectives from medical, commercial and compliance
leaders will be shared in order to reach a consensus on the
business practice in the future.
The session is comprised of both individual presentations and
panel discussion.
Setting up Medical Affairs Team and Working with Business
Partner
Jingdong MA
Medical Affairs Director, Ferring
Michele SIMON
Director Operations, Medical Communications, PPD, UK
Patient Education in the Medical Driven Era
Bowen ZHANG
Vice President, Sales and Marketing, MobileMD System
Publication Strategy in Product Life Cycle Management
Eric YU, PhD
Medical Publication Manager, MC&PM, Medical Division,
Shanghai Roche Pharmaceuticals Ltd.
Session 1208 | Wednesday, 18 May
15:30–17:30 | 3rd Floor, 301A
HEOR AND MARKET ACCESS IN CHINA
SESSION CHAIR
Jianwei XUAN, PhD
Professor, Director
Health Economic Research Institute, Sun Yat-Shen University
The Medical and Commercial Collaborations
Joicey CHEN, MBA
Business Unit Head, Lilly Oncology
Medical Affairs & Business Unit Collaborations: How to Ensure
the Business Compliance
Tracy XU
Manager, Corporate Compliance, Boehringer Ingelheim
Session 1207 | Wednesday, 18 May
Globalization and Innovation: Trends Aimed at Improving the
Customer Experience
Simultaneous
Translation
In this session, we will discuss the application of health economic
evaluation in pharmaceutical industry to support pricing and
market access.
Health Economic Evaluation, Pricing and Market Access
Jianwei XUAN, PhD
Professor, Director
Health Economic Research Institute, Sun Yat-Shen University
13:30–15:00 | 3rd Floor, 301A
Health Economic Evaluation in the Industry
MEDICAL COMMUNICATION: OPPORTUNITIES UNDER THE
“NEW NORMAL”
SESSION CO-CHAIRS
Libo TAO, PhD
Director of Market Access, Health Economist, GE HealthCare
Huafei LI
Director, Medical Communication & Project Management,
Medical Affairs, Roche
Real Cases of Health Economic Application in Industry
Jianxiu YU
MI Director, Area Lead/Head of MI China, Global EMC,
Pfizer Investment Co., Ltd.
“Single digit growth”, “Change”, “Innovation”, “Internet+”
are the key words of now and foreseeable future of China
pharmaceutical market. It requests medical affairs to embrace
the change, transform the challenge into opportunity through
take innovative initiatives, be more precise and clear on the
communication, improve the effectiveness and expand impact.
This session will provide you an overview on the Medical
Communication development in in China, provide highlight
on patient education and share best practice on publication
planning and innovation on medical information and medical
communication.
Qiang SHI, MD, PhD
Associated Director, Eli Lilly
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2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
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TUESDAY, 17 MAY | WEDNESDAY, 18 MAY
THEME 13 | THEME 14
Rare Disease: Phenotype and Gene
Theme
13
Weihong GU, MD, PhD
Head, Movement Disorders and Neural Genetic Disease
Research Center, China–Japan Friendship Hospital
Rare Diseases Forum
Session 1301 & 1302 | Tuesday, 17 May
Simultaneous
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08:30–12:00 | 3rd Floor, 305
RARE DISEASES –
PART 1:THE CONCEPT OF RARE DISEASES
PART 2: THE PRACTICE OF RARE DISEASES
SESSION CO-CHAIRS
Jack XU, MD
Senior Vice President, Shanghai Clinical Research Center
Kevin HUANG
President, Chinese Organization for Rare Disorders (CORD)
Rare diseases are one of the greatest challenges facing human
medicine, known 7000 kinds of rare diseases, 80% of them
belong to the genetic deficiency diseases, our understanding of
them is still limited, there are effective treatments for the disease
less than 5%, most drugs not even in the Chinese market, China is
facing nearly 10 million patients with no cure dilemma.
Although China in the field of rare diseases has a great distance
from USA/European countries, the rapid development in recent
years has been happen. With the efforts of all relevant parties,
the civil society has been effectively enhance the awareness,
diagnosis and treatment of rare diseases continues to increase,
the country actively explore the medical care path for the
rare diseases and the patient organizations have called public
attention, China is moving in a positive and effective direction to
solve the overall problem of rare diseases.
The International Policy Comparison of Orphan Drug and Its
Revelation to China
Luwen SHI
Professor, Peking University School of Pharmaceutical Sciences
Reproductive Intervention of Rare Diseases
Guangxiu LU
President, Reproductive and Genetic Hospital of CITIC Xiangya
Rare Disease Genetic Counseling
Shangzhi HUANG , MD
Professor, Peking Union Medical College, Department of Medical
Cenetics Who Collaborating Center for Community Control of
Hereditary Diseases
Role of Rare Disease Patient Organization
Kevin HUANG
President, Chinese Organization for Rare Disorders (CORD)
In China for Global: Orphan Drug R&D in China
Weiyi ZHENG
Chairman & Chief Executive Officer, Nanjing Innov Pharma
Theme
14
CRO/SMO
Session 1405 | Wednesday, 18 May
08:30–10:00 | 3rd Floor, 301B
READY FOR THE BIG WORLD? – HOW CAN CHINESE
PHARMACEUTICAL COMPANIES LEVERAGE CRO TO GROW
BIGGER AND FASTER?
SESSION CHAIR
Jason ZHU, MD, MBA
Vice President, Deputy General Manager
& Head of Business Development, Greater China,
Quintiles Enterprise Management (Shanghai) Co. Ltd.
China based Drug manufacturers often team up of a highly
specialized CMC talents and Molecular Designers at a top global
standard, but usually have hard time developing a solid Target
Product Profile and Clinical Development Strategy afterward. This
will disable them to further layout a practical and commercially
attractive global clinical delivery pathway. A Tailored Global
clinical development approach will help drug developers well
utilize their existing resources (Competitive landscape China
market knowledge, Chinese patient Stand of Care knowledge,
etc) to further bridge into the global component and help them
realize their asset value to the targeted stage earlier.
Build a Partnership from Scratch– the Art of Selecting a CRO
Hualong SUN, MD, PhD
General Manager, Meta Clinical Technology
Include a CRO in Your Business Strategy – How to Manage the
Relationship with the CRO in Your Daily Work
Yan WU, MD, PhD
Head, Clinical Operation and Drug Safety
Hutchison MediPharma
Begin with the End in Mind – DOs and DONTs of Planning and
Conducting Global Trials
Yong GUO, PhD
Vice President, Gmax Biopharm
Panel Discussion
All Speakers Above and Invited Panelist
Meiyu GENG
Professor, Vice Director
Shanghai Institutes for Biological Sciences
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
TUESDAY, 17 MAY | WEDNESDAY, 18 MAY
Session 1406 | Wednesday, 18 May
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THEME 14 | THEME 15
Session 1408 | Wednesday, 18 May
10:30–12:00 | 3rd Floor, 301B
15:30–17:30 | 3rd Floor, 301B
TIME FOR AN UPGRADE – EVOLVING COOPERATION MODEL
BETWEEN CROS AND PHARMACEUTICAL COMPANIES
SESSION CHAIR
SMO/CRC – A BRIDGE OVER THE TROUBLED WATER
SESSION CHAIR
Cory WILLIAMS, MD, PhD
Vice President, Global Clinical Trial Execution,
Global Product Development, Pfizer
Paradigm Shift – Global Trend in Partnership Model, Study
Design etc., and Why Pharma Companies Want It
Jennifer HUANG
Executive Director, Head of Global Clinical Trial Operation,
Merck Research Laboratories R&D (China), Ltd.
In the Fast Lane – Challenges and Opportunities for China
Domestic CROs
Hadrian FU, PhD
General Manager, Shanghai Cares Bio–tech Co. Ltd
Paving the Way for Industry Sponsored Research into Malaysia
Khairul Faizi bin KHALID
Head, Business Development, Clinical Research Malaysia
Panel Discussion: All Speakers Above
Session 1407 | Wednesday, 18 May
13:30–15:00 | 3rd Floor, 301B
Min JIANG
Director, GCP Administration Office, Beijing Oncology Hospital
CRC’s Strategy to Bridge the Expectation Gap between Sponsor
and Investigator
Veronica XIA, MBA
Vice President & General Manager, Kuntuo
No Weakest Link – Quality Control and Training for CRC
Jian YANG
Head of Site Management Organization, Beijing Clinical Service
Center
Level Up – Project Management of SMO
Reako REN
Executive Director and Head of SMO Services, WuXi AppTec
(Shanghai) Co., Ltd.
Theme
15
Information Technology
A JOURNEY WITHOUT DETOUR – DATA QUALITY MATTERS
SESSION CHAIR
Zhi–Qiang NING, MD, PhD
Vice President R&D, Shenzhen Chipscreen Biosciences Ltd
Session 1506 | Wednesday, 18 May
Data quality is a key component of clinical trials, which reflects
a comprehensive capability of study investigator and sponsor
or CRO. In this Session, speakers introduce and expand the
importance and the ways of data quality control from either
study-site point of view or sponsor/CRO’s perspectives.
INFORMATION TECHNOLOGY IN CLINICAL STUDIES –
REGULATORY REQUIREMENT
SESSION CHAIR
Importance of Data Integrity – Observation and Reflection on
the Recent Events
Juyong WANG, MD, PhD
Director, GCP Administration Office, Longhua Hospital
Good Documentation Practice on TMF in CROs and Sponsors
Sarah ZHUANG
Project Leader, Project Leadership, PAREXEL International
Panel Discussion: In the Same Boat – The Roles and
Responsibilities of Different Parties to Keep Data Integrity
All Speakers Above and Invited Panelist:
Hualong SUN, MD, PhD
General Manager, Meta Clinical Technology
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10:30–12:00 | 3rd Floor, 306B
Charles YAN, PhD
Senior Director, Data Management,
Shanghai Hengrui Medicine Co, Ltd.
The clinical applications of information technology in developed
countries have more strict regulations and regulatory
requirements. However, with relatively short period of GCP
history and few applications in clinical trial in China, it is needed to
establish and improve relevant laws and regulations, particularly
under the current environment where CFDA emphasis on data
integrity and reality. This session will introduce requirements
for information systems in Europe and America, to promote the
progress of information technology in clinical research to meet
international standards.
Information Technology in Clinical Research: Regulatory
Requirements
Frances NOLAN, MBA
Vice President, Quality & Regulatory Affairs,
Medidata Solutions
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2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
TUESDAY, 17 MAY | WEDNESDAY, 18 MAY
21 CFR Part 11 and Its Application in Clinical Research
James STREETER
Global Vice President, Life Sciences Product Strategy, Oracle
Health Sciences
Guidance for Electric Data Capture (EDC) in Clinical Trials
Qin HUANG, PhD
Senior Reviewer, Deputy Director (Acting), Office of
Biostatistics, Center for Drug Evaluation, CFDA
Session 1507 | Wednesday, 18 May
THEME 15 | THEME 16
Information technologies revolutionize the process and method
of clinical research. Business At this state of the technology
industry, every company must be studying how Mobile, Social,
Cloud and Big Data will revolutionize their business. The explosive
growth in these areas will have a dramatic impact on the world
of drug and device development, and time will tell if regulatory
agencies, CROs and Pharma can respond quickly enough.
This session will provide the future trend of clinical trial with the
information technologies development.
13:30–15:00 | 3rd Floor, 306B
“Modernize” Clinical Trials - Where Are We Now and Where Are
We Going?
THE APPLICATION OF INFORMATION TECHNOLOGY IN
CLINICAL TRIALS
SESSION CHAIR
Ling XU
Clinical Operations Manager, Study & Quality Management,
Boehringer-Ingelheim China
Charles YAN, PhD
Senior Director, Data Management,
Shanghai Hengrui Medicine Co, Ltd.
The application of information technology in clinical trials in
China is relatively less-advanced as our trial operations largely
depend on manual work and paper process. However, with the
strong support of State scientific and technological innovation,
domestic pharmaceutical companies have invested increasingly
in drug research and development, including information
technology.
The electric management of clinical data, process and
documents will change the way of clinical research in process
and methodology, and improve trial quality and efficiency. This
session will share the practices of information technology in the
clinical research, in order to further promote the progress of
information technology in clinical research and development in
China.
Information Technology: A Way to Enhance the Efficiency and
Quality of Clinical Trial
Mobile Technology Advances Modern Clinical Trials
Tom XIE, PhD
President & Chief Executive Officer, Brightech International/
Chengdu Ming Ke
EMR Application in Clinical Research
Hongwei CAI, PhD
Associated Professor, Information Technology Department,
School of Stomatology, 4th Military Medical University
Big Data in Clinical Research
Hong ZHOU
Chief Executive Officer, DAPChina
Theme
16
Medical Devices
Yonglong ZHUANG
General Manager, Bioknow
Pharmacovigilance in Clinical Studies
Jia HE, PhD
Professor, 2nd Military Medical University
Clinical Documentation Management
Lily FENG, MBA
Principal Product Manager, Veeva Systems
Integration of e-Clinical Solutions in Clinical Trials
Charles YAN, PhD
Senior Director, Data Management,
Shanghai Hengrui Medicine Co, Ltd.
Session 1508 | Wednesday, 18 May
15:30–17:30 | 3rd Floor, 306B
INFORMATION TECHNOLOGY IN CLINICAL STUDIES –
SESSION CHAIR
Yazhong DENG, MBA
Head of Clinical Data Analysis and Reporting Organization
(CDARO), Covance, China
Session 1601 & 1602 | Tuesday, 17 May
Simultaneous
Translation
08:30–12:00 | 3rd Floor, 302B
CHALLENGES AND OPPORTUNITIES IN THE NEW
REGULATORY AND INNOVATION ENVIRONMENT: POLICY AND
REGULATION – PART 1 & PART 2
SESSION CO-CHAIRS
Mingdong ZHANG
Chief Medical Officer & Senior Director of Regulatory Affairs,
Boston Scientific China
Annie YIN
Senior Director, Regulatory Affairs, J&J Medical China
China medical device regulations have been changed dramatically
in past two years. How to interpretation and implementation
the regulations to accommodate the innovation have been
challenging. This session will invite experienced speakers to
share their perspective and best practices on the hot areas.
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
TUESDAY, 17 MAY | WEDNESDAY, 18 MAY
Clinical Evidence Required for Device Approvals by US FDA
Mingdong ZHANG
Chief Medical Officer & Senior Director of Regulatory Affairs,
Boston Scientific China
China Regulations Update of Medical Devices
Gang DENG
Vice Director, Center for Medical Device Evaluation, CFDA
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THEME 16 | THEME 17
Non-clinical safety assessment is one of the critical processes in
the new drug R&D and bridging the drug discovery and clinical
development together. It takes an essential role to guide the Go/
No-Go decision, clinical study design and monitoring as well
as the drug labeling. In this session, we will invite the experts
from CFDA and pharmaceutical industry to illustrate and discuss
how the non-clinical safety assessment supports the clinical
development and new drug registration.
CFDA’s Requirement on Pre-Clinical Assessment in New Drug
Development
China Regulatory Environment and Challenge
Chen YANG, LLM
Partner, Sidley Austin Beijing Office
Qingli WANG, PhD
Deputy Director (Acting), Office of Pharmacology and
Toxicology, Center for Drug Evaluation, CFDA
Special Review Process – Innovation Green Channel
Gang DENG
Vice Director, Center for Medical Device Evaluation, CFDA
Design and Implementation of Non-Clinical Safety Assessment in
Different Stages of New Drug Development
Preparation and Acceptance of Oversea GMP Inspection
Charles WANG, PhD
Director and Head of Safety Assessment, GSK R&D Shanghai
Aijun WANG
Division Chief, Division of Inspection III, Center for Food and
Drug Inspection, CFDA
Session 1603 | Tuesday, 17 May
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Translation
13:30–15:00 | 3rd Floor, 302B
OPPORTUNITIES IN THE NEW REGULATORY AND INNOVATION
ENVIRONMENT: INDUSTRY OPPORTUNITY
SESSION CO-CHAIRS
The Significant Meaning of New Drug Toxicology Data for Clinical
Study Design
Jing MA
Director, National Shanghai Center for New Drug Safety
Evaluation Research Center
Session 1706 | Wednesday, 18 May
Simultaneous
Translation
10:30–12:00 | 3rd Floor, 302B
Mingdong ZHANG
Chief Medical Officer & Senior Director of Regulatory Affairs,
Boston Scientific China
PHARMACOMETRICS AND MECHANISM–BASED PK/PD
MODELING IN EARLY DRUG DEVELOPMENT
SESSION CHAIR
Annie YIN
Senior Director, Regulatory Affairs, J&J Medical China
Sylvia ZHAO, PhD
Director of Clinical Pharmacology, Translational Clinical
Oncology Shanghai, China Novartis Institutes for BioMedical
Research
Medical Device Market Investment Opportunity
Yunxia YANG
Managing Director, Sequoia Capital
Opportunities of Post Marketing Studies in China
Amber FANG, MBA
Senior Clinical Manager, Edwards
Theme
17
Early Stage Drug Development
Session 1705 | Wednesday, 18 May
08:30–10:00 | 3rd Floor, 302B
NON–CLINICAL SAFETY ASSESSMENT IN THE NEW DRUG
DEVELOPMENT
SESSION CHAIR
James YAN, MD, PhD, DABT
Executive Vice President, Head of Early Development and Drug
Safety, Zai Lab
Pharmacometrics and mechanism–based PK/PD modeling
have increasing application and even become an indispensable
discipline in drug development nowadays. They play important
roles in drug selection and characterization, and drive clinical
drug development especially dose/dose regime decision. In this
session of the 8th DIA meeting, the experts from US FDA and
pharmaceutical industry are invited to provide in–depth review
of the cutting–edge methodology and practices at industry and
health authorities through open discussion of issues and needs in
early drug development.
Clinical Pharmacology Guided Dose Escalation-Moving From
Phase II to Phase III
Dennis BASHAW, PharmD
Director, Division of Clinical Pharmacology–3, Office of Clinical
Pharmacology, Office of Translational Sciences, FDA, USA
Preclinical PKPD: Translation from Preclinical Species to Human
Giorgio OTTAVIANI, PhD
Head of Pharmaceutical Sciences, Roche Shanghai
Application of Pharmacometrics in Drug Development
He SUN, PhD
Vice President, Tasly Holding Group
86
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2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
TUESDAY, 17 MAY | WEDNESDAY, 18 MAY
Session 1707 | Wednesday, 18 May
Simultaneous
Translation
13:30–15:00 | 3rd Floor, 302B
Theme
BIOMARKERS AND TRANSLATION MEDICINE
SESSION CHAIR
18
Eric LIANG, PhD
Global Program Manager
Translational Clinical Oncology Department, Novartis
Precision medicine builds on the ever-expanding understanding
of disease biology. Many research advances illustrate how
specific vulnerabilities in cancer can be exploited to develop
powerful new treatment. Genetic mutations that cause cells to
make abnormal protein can lead to cancer and other disease.
This finding suggests that many patients may benefit from a
targeted treatment that blocks the cancer-fueling protein based
biomarker assessment.
Biomarkers in Cancer Management
David NEWELL, PhD
Professor, Cancer Therapeutics, Newcastle University Director,
Translational Research, Cancer Research, UK
The Molecular Markers of Lung Cancer
Xuchao ZHANG, MD, PhD
Professor, Vice Director, Guangdong Lung Cancer Institute,
Medical Research Center of Guangdong General Hospital,
Guangdong Academy of Medical Sciences
Companion Diagnostics
Session 1803 & 1804 | Tuesday, 17 May
13:30–17:30 | 3rd Floor, 301A
MOLECULAR INFORMATION TOWARDS NEW ERA OF
PRECISION MEDICINE - PART 1 & PART 2
SESSION CO-CHAIRS
Harry YANG, PhD
Director, Head of Personalized Healthcare & Biomarkers,
AstraZeneca China
James CREEDEN, MD, PhD
APAC Medical Director, Roche Molecular Information
Audience will gain a general understanding of Precision Medicine
and companion diagnostics, and the current use of different
companion diagnostic technologies in R&D and clinical practice
and create an dialog among biotech/IVD companies and China
FDA to discuss evolving regulatory needs in this session.
PARP Inhibitors: BRCA and Beyond
Min HU, PhD
Principal Scientist, Genetics Team Leader
Biomarker, Asia & Emerging Markets iMed,
AstraZeneca Investment (China) Co., Ltd.
Ethnic Difference & Precise Medicine in Clinical Drug
Development & Medical Practice
Charles XIE, MD, PhD
Director, Early Clinical Development
Boehringer Ingelheim China
Session 1708 | Wednesday, 18 May
THEME 17 | THEME 18
Simultaneous
Translation
15:30–17:30 | 3rd Floor, 302B
EARLY CLINICAL DRUG DEVELOPMENT
SESSION CHAIR
Bin PENG, MD, PhD
Global Head, Translational Clinical Oncology Shanghai, China
Novartis Institutes for BioMedical Research
Early clinical study is an important stage for drug development.
There are multiply approaches or models for early clinical study.
This session will give a brief introduction of new concept and new
models for early study by experts from CFDA and pharmaceutical
companies.
Cancer treatment, Past, Present and Future
Bin PENG, MD, PhD
Global Head, Translational Clinical Oncology Shanghai, China
Novartis Institutes for BioMedical Research
Cardiac Safety Assessment in Early Clinical Drug Development
Haiyan LI, MD
Professor of Cardiology
Director, Drug Clinical Trial Center
Peking University Third Hospital
Early Biosimilar Development: A Model for Expeditious Progress
to a Phase III Trial
Nigel J. RULEWSKI, MD
Vice President, Global Strategic Drug Development, Head,
Biosimilar Center of Excellence, Quintiles
Comprehensive Genomic Profiling in the Age of Targeted
Therapy
Jianying HUANG
Medical Manager, Roche Molecular Information
Development of CDx - The Approach to Support Precision
Medicine
Nick ZHANG, PhD
Chief Executive Office, Qiagen (Suzhou) Translational Medicine
Company
Companion Diagnostics: Beyond Therapy for Oncology
James WU, PhD
Vice President and General Manager, Clinical Diagnostics,,
WuxiAppTec
The Perspectives of CDx Regulation in China with Comparison to
US and EU
Jinjie HU, PhD
Member of the FDA Alumni Association International Network
(FDAAA)
Former Senior Reviewer, Office of Blood Research and Review,
US FDA/CBER
Senior Consultant, Biologics Consulting Group, INC.
Panel Discussion
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
TUESDAY, 17 MAY | WEDNESDAY, 18 MAY
Theme
19
87
THEME 19
Joe DUSTIN
Principal Mobile Health, Medidata
White Paper Showcase
Maya SHEVLYAKOVA
Biostatistician, Clinical Development Unit
Nestlé Research Center, Lausanne, Switzerland
Session 1905 | Wednesday, 18 May
Session 1901 | Tuesday, 17 May
08:30–10:00 | 3rd Floor, 308
08:30–10:00 | 3rd Floor, 308
VALUE OF PHARMACOMETRIC ANALYSES IN DRUG
DEVELOPMENT
CERTARA L.P.
CLINICAL TRIAL IN MOBILE INTERNET ERA: MODEL
OPTIMIZATION AND EFFICIENCY IMPROVEMENT
MOBILEMD SYSTEM
How can Pharmaceutical industry leverage Internet technologies
to improve efficiency, reduce cost, and upgrade quality for its
clinical development? How to achieve better “patient centricity”
in clinical studies? Industry experts are invited to share their
views and address your questions.
Model Optimization of Clinical Trials by Mobile Internet
Industry Expert invited
Challenges of Clinical Trial in China and Informatics Solutions
Dong MA
Medical Master, MBA Candidate, Director of Clinical Research,
MobileMD System
R&D of Pharmaceutics: Another Blue Ocean of Internet+
Speaker Invited, Northern Light Venture Capital
MobileMD CTMS Mobile Version Launch
Panel Discussion
Session 1902 | Tuesday, 17 May
10:30–12:00 | 3rd Floor, 308
THE PATH FORWARD OF FUTURE CLINICAL TRIALS
MEDIDATA SOLUTIONS
2015 was the year of change. New guidelines and announcements
from CFDA have been rolled out, particularly on data self check
and data quality. So how to enhance the data quality using EDC
system and to better collect patient data is the key of success in
clinical trials. In this session, we will have four expert speakers to
discuss with us about the direction of future clinical trials moving
forward.
Topics include the current and future development of the
regulations and guidelines of data quality in China; Sharing from
sponsor on EDC functions that improve site protocol adherence
and ability for sponsors to monitor and control data quality;
Future technology which helps to conduct better trials with
the sharing of mHealth project example between Nestle and
Medidata in China.
Frances NOLAN
Vice President, Global Quality Assurance, Medidata
Sarah WANG
Associate Director of CDM in Boehringer Ingelheim (China)
Investment Co., Ltd.
The process of drug development is extremely time consuming
and costly. It takes approximately 10-12 years and costs hundreds
of millions or billions dollars. Pharmacometrics is the scientific
discipline that uses mathematical models based on biology,
pharmacology, physiology, and disease for quantifying the
interactions between drugs and patients. Its purpose is to reduce
cost and shorten development time by optimizing the clinical
assessment of efficacy and safety. This presentation highlights
the value of pharmacometric analyses in drug development
through selected examples.
Christine Yuying GAO, MD, PhD
President & CEO, Certara Strategic Consulting China
Session 1906-1 | Wednesday, 18 May
10:30–12:00 | 3rd Floor, 308
DRIVE GLOBAL INNOVATION WITH AN INTEGRATED DRUG
DEVELOPMENT STRATEGY
COVANCE
With China being the world’s fastest growing pharmaceutical
market, Chinese pharma and biotech companies have an
advantage for simultaneous development and approval of new
innovative products in China and the US/EU. Our session will
focus on how to drive global innovation with an integrated drug
development strategy, including how to develop supported value
propositions to enhance product differentiation on the market,
how to use smart regulatory strategies to leverage global drug
development, what to consider for Chinese innovation to goglobal as well as applying biomarker and companion diagnostic
strategies to enhance global drug development.
Moderator
Kenneth SOMBERG, MD, MBA
Chief Medical Officer, Covance
Developing Supported Value Propositions to Enhance Product
Differentiation
Cheryl STEWARD, MPA,
Vice President, Market Access Services, Covance
Using Smart Regulatory Strategies to Leverage Global Drug
Development
William HANLON, PhD
Vice President, Head of Global Regulatory Affairs, Covance
迎接法规变革,聚力专业质量
2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
88
WEDNESDAY, 18 MAY
Chinese Innovation and Global Drug Development
Considerations
Eric LANG, MD
Vice President, Molecule Development Group, Covance
Biomarker & Companion Diagnostic Strategies for Global Drug
Development
Mark ROBERTS, PhD
Director of Diagnostics Development, Covance
Panel Q&A
Session 1906-2 | Wednesday, 18 May
10:30–12:00 | 3rd Floor, 305
AUSTRALIA: A PREMIER DESTINATION FOR EARLY STAGE
CLINICAL TRIALS
SUB – TITLE: LEADERSHIP IN SPEED, QUALITY AND COST
COMBINED WITH GOVERNMENT REFORMS ENHANCE ITS
COMPETITIVE ADVANTAGE
NOVOTECH
With a strong research environment, Australia is a vibrant, worldrecognised destination for early phase clinical trials. A leader
across the key dimensions of speed, quality and cost, Australia
has fast, flexible clinical trial approval processes at a competitive
global cost. Australian investigators are highly regarded, and
data from Australian trials is internationally recognised. The
Government also provides attractive incentive schemes to boost
R&D. Join this showcase by Frost & Sullivan highlighting Australia
as the premier destination for early phase clinical trials in Asia
Pacific.
THEME 19
Session 1907 | Wednesday, 18 May
13:30–15:00 | 3rd Floor, 308
PHARMACOVIGILANCE – CUSTOMIZED SAFETY DATABASE
FOR CHINESE REGULATIONS
ARISGLOBAL KK
The China Adverse Drug Reaction Monitoring System (CDARMS)
receives data from several drugs and vaccine manufacturers
in China. By 2013, CADRMS had received over 6.6 million ADR
case reports. Safety data capture, management, reporting and
analytics by manufacturers remains an area for improvement.
Technology forms the backbone of efficient pharmacovigilance
systems. ArisGlobal a global leader in providing technological
solutions for pharmacovigilance has released a product in China
specifically addressing the needs of the Chinese regulations.
Because of the Chinese language interface and integration with
Chinese Medical Products dictionary it has become very popular.
ARISc has been chosen as the safety database of choice by a
Chinese government owned manufacturer company.
Pharmacovigilance – Customized Safety Database for Chinese
Regulations
Vivek AHUJA, MD, MBA
Vice President, Global Pharmacovigilance, ArisGlobal
ArisGlobal Overview
ARISc/Product Demo
Rhenu BHULLER
Partner, Transformational Health, Frost & Sullivan
SAVE TIME AND TRAVEL COSTS
with IN-COMPANY TRAINING
All DIA Training Course can be held on your premises and tailored
to your needs. Get the best value and train your whole team!
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
壁报
POSTER PROGRAM
#
CATEGORY
1
Project Kick-Off of Data Operations
Professional
2
China
Yingyin Amber CHENG, Dong FANG,
Henry SHEN, Lifang Jasmine SUN,
Karen TYE, Ning Victoria ZHANG
Pfizer (China) Research and Development
Co., Ltd
China
Brian EDWARDS
NDA Regulatory Science Ltd.
United Kingdom
Lu LU (路璐)
诺和诺德(天津)科技有限公司 (NNIT)
China
Meng CHEN, Linda ZHENG, Fan XIA,
Lynna ZHAO, Apple YING, Aonghus WALSH
Roche (China) Holdings Ltd.
China
Panpan GU
Pfizer (China) Research and Develop Co., Ltd.
China
Jinjin ZHANG, Jin WANG, Pei MAO, Alexander
KOSTEK, Edith EBY, Ericka EDA
Pfizer (Wuhan) Research and
Development Center
China
Pfizer China R&D Center
China
Roche (China) Holdings Ltd.
China
Roche (China) Holdings Ltd.
China
Roche (China) Holding Ltd.
China
Roche (China) Holding Ltd.
China
Qing ZHANG
Pfizer (Wuhan) Research and
Development Co., Ltd.
China
Rui XU, Qing ZHANG
Pfizer China R&D Center
China
Tingting XU
Roche Product Development Asia Pacific
China
Tracy LI, Stella GU, Ting LI
Roche (China) Holding Ltd.
China
Jing JIANG
Xiuting MI, Mina CHEN
Meng CHEN, Mandy YU
Julie LEE, Hangjun DAI, Haiyan WU
Hui ZHANG
Pfizer Medical Information
Professional
19
Pfizer (China) Research and Develop Co., Ltd.
Providing Trusted Clinical and Scientific Product Information
Professional
18
Ying ZHANG
Data Quality Status Report
Professional
17
China
Biomarker Detection in Roche PD Shanghai
Professional
16
Roche (China) Holdings Ltd.
Biosimilar and Key Considerations for Clinical Development of Biosimilar
Professional
15
Amitkumar TIWARI
Analytics Journey to Real World Data
Professional
14
China
Pharmaceutical Safety Surveillance: Labeling
Professional
13
Pfizer (Wuhan) R&D Center
Develop Innovative Solution to Fill the Unmet Medical Needs in China– Special Focuses on Oncology
Professional
12
Pei MAO, Alex KOSTEK, Cynthia BARBITSCH
Exploring Differences in Clinical Study Reports Between China and ICH Regions
Professional
11
Iran
iDRUG - an Internal Campaing to Surface Innovations in Drug Development
Professional
10
Urmia University of Medical Sciences
NNIT Enterprise Hybird Cloud Services
Professional
9
Rohollah VALIZADEH
The Time to Apply Organizational Science to Systematically Manage the Risks of Medicines is Overdue
Professional
8
China
Innovation in Clinical Programming and Writing: Automated Tools to Improve Quality and Efficiency
Professional
7
Meta Clinical Technology Co.Ltd
Overview of Regulatory Submission Requirements for NDA in Asia
Professional
6
COUNTRY
The Study Builder - A GDSR Extension Tool from “Study Workflow Automation” Initiative
Professional
5
Dorothy DAI
ORGANIZATION
New Process Model for Academic-Industry partnerships - Pfizer Clinical and Research Collaboration Program
Professional
4
AUTHOR
Prevalence of Depression in Students and Effective Factors at Urmia University of Medical Sciences In 2016
Student
3
91
独立数据监察委员会(Independent Data Monitoring Committee)
Professional
20 Job Shadowing
Professional
迎接法规变革,聚力专业质量
2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
92
讲者索引
SPEAKER INDEX
LAST NAME
FIRST NAME
SESSION #
LAST NAME
FIRST NAME
SESSION #
AHUJA
Vivek
1907
EDWARDS
Brian
1004
ALLES
Mark J.
Keynote
EVANS
Adrian
0705 & 0706
ATKINSON
Samantha
0705 & 0706
FANG
Amber
1603
BAO
Wenjun
Workshop 4
FENG
Lily
1507
BASHAW
Dennis
1706
FENG
Yi
0101
BASRUR
Roopa
1106
FONG
Josephine
1003
BERGER
Florence
1105
FU
Hadrian
1406
BERTRAND
Coiffier
0805 & 0806
FU
Jun
0507
BHULLER
Rhenu
1906-2
GAO
Christine
1905
BYE
Carol
0905
GAO
Gao
1004
CAI
Hongwei
1508
GAO
Jingwei
0608
CAI
James
Special Forum
GAO
Jinming
0302
CAO
Dehong
Workshop 4 &
0607-1
GAO
Tao
Workshop 2
CAO
Xiaochun
Workshop 3
GAO
Xiaohui
1107
CARIN
Ellene
Workshop 2
GAWRYLEWSKI
Helle-Mai
1106
CECIL
Nick
0802, 0805 & 0806
GEARY
Edward Stewart
1002
CHANG
Maggie
Workshop 3
CHANG
Andrew
0705 & 0706
CHEN
James
0701
CHEN
Jessie
0605
CHEN
Xiaoxiang
Workshop 1 & 0602
CHEN
Yongchuan
0401
CHEN
Joicey
1206
CHENG
Ying
0506
CHENG
Zengjiang
0704
CHENG
Vivian
1202
CHUNN
Cliff
1106
CONG
Julie
0601
CONNELL
Ann Meeker-O”
0905
COOPER
Julia
1105
DAI
Luyan
DAL PAN
GENG
Meiyu
1405
GOH
Aik
0302
CREEDEN
James
1803 & 1804
GU
Clara
1108
GU
Weihong
1302
GUO
George
0402
GUO
Tong
0601
GUO
Tony
0607-2
GUO
Yong
1405
GUO
Zhongping
0807
HAN
Simeng
0601
HANLON
William
1906-1
HE
Jia
1507
HE
James
1201
HOU
Min
1205
0602, 0607-2 &
0608
HU
Jinjie
1803 & 1804
HU
Min
1803 & 1804
Gerald
0105 & 1001
HU
Pei
Workshop 3
DAVIS
Hugh
0107
HUANG
Jennifer
1406
DENG
Gang
1601 & 1602
HUANG
Jiaying
1803 & 1804
DENG
Irene
Workshop 3
HUANG
Kevin
1301 & 1302
DENG
Yazhong
1508
HUANG
Mei-Chen
0902
DOWLAT
Hoss
0805 & 0806
HUANG
Shangzhi
1301
DUSTIN
Joe
1902
HUMPHRIES
Michael
0302
DU
Guanhua
Special Forum
IMAGAWA
Junichi
1003
DU
Sean
0305
IRWIN
Min
0302 & 0307
DUAN
Dejuan
Workshop 2
JIA
Jidong
0306
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
讲者索引
93
SPEAKER INDEX
LAST NAME
FIRST NAME
SESSION #
LAST NAME
FIRST NAME
SESSION #
JIANG
Amy
0505
LORENZ
Raoul-A.
0102
JIANG
Min
1408
LU
Becky
0702
JIANG
Qi
0607-2
LU
Donghao
0708
KAN
Munching
1107
LU
Guangxiu
1301
KANG
Pengcheng
Workshop 3
LUO
Jiali
0802
KHALID
Khairul Faizi bin
1406
LUO
Tianhong
1201
KITAHARA
Jun
0106
LV
Janet
0801
KOU
Xiujing
1003
MA
Changsheng
0307
KUHL
Alexander
1108
MA
Dong
1901
LANG
Eric
1906-1
MA
Jing
1705
LANG
Zig
1201 & 1206
MA
Jingdong
1206
LEI
Jifeng
0704
MA
Liheng
1202
LI
Echo
1001
MA
Lixian
0102
LI
Eugen
1205
MA
Peilin
0401
LI
Haiyan
0605 & 1708
MAEDA
Daisuke
0105
LI
Helen
0902 & 0905
MANGHI
Sebastiano
0605
LI
Huafei
1207
MARCH
Ruth E.
Workshop 3
LI
Joy
0807
MATTAVELLI
Raffaella Balocco
0801 & 0807
LI
Jun
0902
McCormack
Rose
0301
LI
Nicole F.
0607-2
MURRAY
Richard
0507
LI
Qihan
0305
NEWELL
David
1707
LI
Shuqi
0401
NIE
Lei
0805 & 0806
LI
Shuting
Workshop 1, 0401 &
0402
NING
Yi
0602
LI
Theresa
0108
NING
Zhi-Qiang
1407
LI
Fred
0708
NOLAN
Frances
1506, 1902
LI
Howe
1002
OTTAVIANI
Giorgio
1706
LIANG
Eric
1707
PANG
James
0107
LIANG
Fanny
0701
PENG
Bin
1708
LIANG
Vera
1002
PING
Christina
0506
LIN
David
0703
QI
Charlin
0608
LIN
Li
0102
LIN
Melly
0705 & 0706
LIU
Arron
0402
LIU
Daniel
0606
LIU
Heidi
0901
LIU
Hongbin
0808
LIU
Huichen
0707
LIU
Jessica
0306
LIU
Lingli
0307
LIU
Liyang
Workshop 2
LIU
Yuxiu
Workshop 2
LONG
Eileen
1205
QIAO
Youlin
0305
QIN
Lan
0805 & 0806
QU
Roger
0607-2
QU
Shen
0505
REIMANN
James D.
0607-2
REN
Harry
0301
REN
Reako
1408
ROBERTS
Mark
1906-1
ROY
Partha
0805 & 0806
RULEWSKI
Nigel J.
1708
SCHIEMANN
Peter
Workshop 1
SCHIEMANN
Peter
0905
SCHMITT
Siegfried
0702
迎接法规变革,聚力专业质量
2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
94
讲者索引
SPEAKER INDEX
LAST NAME
FIRST NAME
SESSION #
LAST NAME
FIRST NAME
SESSION #
SCHREITMUELLER
Thomas
0801
WANG
Xiaodong
Keynote
SETIAWAN
Ellyne
Workshop 1
WANG
Xiaoshan
0601
SHAO
Ying
Special Forum
WANG
Xiuqin
Workshop 1 & 0901
SHEN
Joan
0107 & 0108
WANG
Xuhui
1207
SHEVLYAKOVA
Maya
1902
WANG
Yue
0402
SHI
Li
0305
WANG
Zhijian
0705 & 0706
SHI
Luwen
1301
WANG
Charles
1705
SHI
Qiang
1208
WANG
Nan
1105
SHIH
Lawrence Mason
1003
WEI
Lai
0306
SIMON
Michele
1207
WEI
Shifeng
0708
SNAPINN
Steve
0602
WELCH
Joel
0801 & 0802
SOMBERG
Kenneth
1906-1
WILLIAMS
Cory
1406
SONG
Yuqin
0807
WONG
Dennis Anthony
0505 & 0808
STEWARD
Cheryl
1906-1
WU
Duu-Gong
0703
STREETER
James
1506
WU
Eric
0601 & 0602
SUN
He
1706
WU
Haidong
Special Forum
SUN
Hualong
1405 & 1407
WU
Henry
0607-1
SUN
Jasmine
0505
WU
James
1803 & 1804
SUN
Jianhui
0402
WU
Jasmanda
1004
SUN
Wenjun
0305
WU
Jingzi
0306
SYIN
Chiang
0606, 0703 & 0902
WU
Tammy
1105
TAKANO
Tetsuomi
0101
WU
Victor
Workshop 4
TAN
Matthew
1201 & 1205
WU
Yan
1405
TAN
Ivy
0102
WU
Zero
0701
TAO
Libo
1208
WU
Zhi’ang
Special Forum
TIAN
Chunhua
0807 & 1001
XIA
Jielai
0608, 0805 & 0806
TIAN
Cloris
0701
XIA
Veronica
1408
TSU
Lin Ching
Workshop 1
XIE
Charles
1707
WANG
Aihong
1602
XIE
Tom
1508
WANG
Aimee
Workshop 4
XING
Jinsong
Workshop 3
WANG
Jerry
0606
XU
Binghe
0805 & 0806
WANG
Jian
0801, 0805 & 0806
XU
Helen
1108
WANG
Jie
1202
XU
Jack
1302
WANG
John
0607-1 & 0808
XU
Jack
1301
WANG
Juan
0702
XU
Ling
1508
WANG
Juyong
1407
XU
Mingli
0402
WANG
Ke
0602
XU
Ning
WANG
Li
1201 & 1202
Special Forum &
0507
WANG
Miranda
1002
XU
Tracy
1206
WANG
Ouhong
0607-2
XU
Wencheng
1108
WANG
Peter
Workshop 3
XUAN
Jianwei
1208
WANG
Sarah
1902
YAN
Charles
WANG
Tianxun
0506
Workshop 2, 1506 &
1507
YAN
James
1705
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
讲者索引
95
SPEAKER INDEX
LAST NAME
FIRST NAME
SESSION #
LAST NAME
FIRST NAME
SESSION #
YAN
Wendy
0105 & 0106
ZHANG
Jun
0305
YANG
Chen
1602
ZHANG
Nick
1803 & 1804
YANG
Daniel
1001
ZHANG
Wei
0705 & 0706
YANG
Harry
1803 & 1804
ZHANG
Xiquan
0401
YANG
Jian
1408
ZHANG
Xuchao
1707
YANG
Jin
0707
ZHANG
Zibao
0607-1
YANG
Rui
1106
ZHANG
Mingdong
1601, 1602 & 1603
YANG
Yue
1004
ZHANG
Mingping
0702
YANG
Yunxia
1603
ZHANG
Pansie
Workshop 2
YANG
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0306
ZHAO
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0901
YAO
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Workshop 3
ZHAO
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1706
YAO
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Workshop 3
ZHENG
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0701
YAO
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1001
ZHENG
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1302
YE
Xiaofei
Workshop 2
ZHENG
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1201
YIN
Annie
1601, 1602 & 1603
ZHOU
Hong
1508
YU
Eric
1207
ZHOU
Lichun
0704
YU
Jianxiu
1207
ZHOU
Liping
Workshop 1
YU
Wendy
0705 & 0706
ZHU
Bo
0704
YU
Zhigang
0307
ZHU
Chao
0607-2
ZHAN
Siyan
1002
ZHU
Dezhi
0708
ZHANG
Bowen
1207
ZHU
Fengcai
0305
ZHANG
Wei
0608
ZHU
Jason
1405
ZHANG
Allen
Workshop 3
ZHU
Liansheng
0607-2
ZHANG
Carrie
0605
ZHU
Mike
0301
ZHANG
Derek
0108
ZHUANG
Sarah
1407
ZHANG
Jing
0101 & 0106
ZHUANG
Yonglong
1507
ZHANG
Joe
Workshop 3, 0801 &
0808
ZOU
Jessie
0401
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2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
96
参展商名录
EXHIBITOR LIST
Company Name
公司名 (中文)
Booth #
Amoy Diagnostics Co., Ltd.
厦门艾德生物医药科技股份有限公司
K01
ArisGlobal
ASMO DTW Life Sciences
K04
优效医学 大田生命科学
A12
BeiJing Bioknow Information Technology Co. LTD
北京百奥知信息科技有限公司
J08
Beijing Clinical Service Center
北京科林利康医学研究有限公司
H03
Beijing CTS Co., Ltd.
北京赛德盛医药科技股份有限公司
E09
Beijing Jingwei Chuanqi Medicine Services Co., Ltd.
北京经纬传奇医药科技有限公司
E01
Beijing Lawke Health Laboratory Center Company LTD
北京洛奇临床检验所股份有限公司
A03
Beijing linkstart Medical Technology Development Co. Ltd.
北京联斯达医药科技发展有限公司
C01
Beijing S&Q Healthcare Co., Ltd.
北京松乔医药科技有限公司
E08
Beijing Sinocro PharmaScience Co., Ltd.
北京兴德通医药科技有限公司
H08
BEIJING YINGJI LOGISTICS CO., LTD
北京映急物流有限公司
F08
Barrington James
G10
BioClinica
Brightech International, LLC
B03
布莱特及成都明科宏能临床医学研究有限公司
Catalent
CCFDIE
G05
中国食品药品国际交流中心
G07
西斯比亚基础与临床研究中心
H09
Cenduit LLC
Center for Clinical & Basic Research (Beijing) Company Limited
C07
Clinical Research Malaysia
Clinical Software Co., Ltd
B10
K08
北京市科雷尼克软件有限公司
K02
Clinipace Worldwide
G08, G09
Covance Inc.
F06, F07
CRScube Inc.
C09
DIA
DIA中国
DONNELLEY LANGUAGE SOLUTIONS
EPS International (China) Co., Ltd.
L00
K05
上海日新医药发展有限公司
ERT
A11
A06
EXTEDO
J10
Fountain Medical Development Limited
方恩医药发展有限公司
GCP ClinPlus Co., Ltd.
普瑞盛(北京)医药科技开发有限公司
A02
Giant Med-Pharma Service Group
北京精诚医药科技集团
J04
H&J CRO International, Inc.
北京翰博瑞强医药信息咨询有限公司
E05
Hangzhou Ecrf Technology Co., Ltd.
杭州伊柯夫科技有限公司
J09
Hangzhou Tigermed Consulting Co., Ltd.
杭州泰格医药科技股份有限公司
H04
Health Tech Medical Group
煌途医药集团有限公司
A08
ICON Clinical Research (Beijing) Co Ltd
爱恩康临床医学研究(北京)有限公司
F01
IDA
INC Research
C03
H10
爱恩希(北京)医疗科技有限公司
C06
KEOSYS Medical Imaging
C02
kinetiq
H05
KingMed Diagnostics
金域检验
C10
KUN TUO
昆拓
B05
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
参展商名录
97
EXHIBITOR LIST
Company Name
公司名 (中文)
Booth #
LORENZ Life Sciences Group
K07
mdgroup
K10
Medidata
F04, F05
MedXview Inc
益赛仕国际信息技术(北京)有限公司
C05
Merge, an IBM Company
H02
Meso Scale Diagnostics, LLC
A07
MobileMD System Co., LTD
嘉兴太美医疗科技有限公司
G06
NNIT (Tianjin) Technology Co. Ltd.
天津恩恩科技有限公司
F09, F10
Novotech Shanghai Limited
诺佛葛医药咨询(上海)有限公司
E10
NTT DATA CORPORATION
株式会社NTT DATA
H01
Ogrin Partner Consulting Ltd.
北京欧格林咨询有限公司
J06
OmniComm Systems, Inc.
H07
Oracle Health Sciences
甲骨文 健康科学
K03
PAREXEL China Co., Ltd
精鼎医药研究开发(上海)有限公司
F02, F03
PPD
J02
PRA Health Sciences
A04
Project Management Institute (PMI)
项目管理协会(PMI)
Q Solutions
QIAGEN (Suzhou) Translational Medicine Co., Ltd.
B04
H06
2
凯杰(苏州)转化医学研究有限公司
Quintiles
K06
B06, B07
R&G PHARMASTUDIES CO LTD
诺思格(北京)医药科技股份有限公司
E07
Rundo International Pharmaceutical Research & Development Co.,
Ltd.
润东医药研发(上海)有限公司
B08, B09
SF Cold Chain
顺丰冷运
K09
SG Research International
G01
Shanghai ADICON Central Laboratory
上海艾迪康中心实验室
E06
Shanghai Jsure Health Co., Ltd.
上海捷信医药科技股份有限公司
C04
Shanghai MUDI Biotech Co., Ltd.
上海妙一生物科技有限公司
J05
Shanghai Pharmaceutical ZhongXie Co., Ltd.
上海医药众协药业有限公司
C08
Shanghai Shengsheng Logistics Co., Ltd
上海生生物流有限公司
J01
Shanghai Yaoshangfei Biologicals Cold Chain Logistics Co., Ltd
上海耀尚飞生物制品冷链物流有限公司
G04
SMO Clinplus Co., Ltd. 普蕊斯(上海)医药科技开发有限公司
A01
Springer Nature
施普林格 • 自然集团
A05
TransPerfect Translations International Inc.
A10
Trifecta
G03
Uppsala Monitoring Centre
A09
Veeva Systems, Software (Shanghai) Co., Ltd
维我软件(上海)有限公司
E02, E03
World Courier (Shanghai) Co., Ltd.
世递国际货物运输代理(上海)有限公司
E04
WuXi AppTec MedKey
药明康德 津石医药
G02
WuXi Clinical Development Services (Shanghai) Co., Ltd.
上海康德弘翼医学临床研究有限公司
B01, B02
Zigzag Associates Ltd
Zuellig Pharma Specialty Solutions Group
J03
裕利医药特别解决方案部
J07
迎接法规变革,聚力专业质量
2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
98
参展商介绍
EXHIBITOR DIRECTORY
Amoy Diagnostics Co., Ltd.
厦门艾德生物医药科技股份有限公司
ASMO/DTW Life Sciences
优效医学/大田生命科学
Booth #K01
Company Introduction
厦门艾德生物专注于肿瘤精准医疗分子诊断产品的创新研发和
产业化。已有EGFR、 KRAS、 NRAS、 BRAF、 PIK3CA、
EML4-ALK、ROS1、ALK/ROS1、KRAS/NRAS/BRAF/
PIK3CA九种基因突变检测产品率先获得CFDA《医疗器械注
册证》和欧盟CE认证。艾德医学检验所为拥有“医疗机构
执业许可”资质的独立第三方医学检验机构,旨在提供最专
业的肿瘤分子检测中心实验室服务;拥有ARMS,ddPCR,
NGS、FISH等7个技术平台,并以国际通用的实验室运行
标准进行管理和质控,拥有完善的检测流程。可支持服务于
不同阶段的临床研究,是AstraZeneca、Pfizer、Merck、
Janssen、Quintiles、Boehringer-Ingelheim等国际知名企业
的合作伙伴。
公司地址:福建省厦门市海沧区鼎山路39号
邮编:361027
联系人:卓燕瑜
电话:+86 18906004618 | 传真:+86 592- 6806 839
电子邮箱:[email protected]
Company Introduction
Booth #A12
ASMO was established in Beijing with the establishment of
affiliated agency around 20 cities in China.ASMO devotes to
perform quality and efficient clinical researches and meet
people’s unmet healthy needs.We offer management service
of ASMO for growing and clinical research all around the world
through leading to the international advanced clinical research
management system,integrating excellent domestic researchers’
resources and building recruitment network of subjects with
ASMO’s features.
[CRO] [SMO] [Recruitment] [Audit]
DTW Group was founded in 1992, is the national 5A class logistics
enterprises, China top 100 logistics enterprises.DTW has began
life science clinical trials logistics business since 2003, and
established a life science division in 2007.
优效医学成立于北京,在国内的20个城市建立了分支机构。
致力于实施优质高效的临床研究,满足人们未被满足的健康需
求。通过引进国际先进的临床研究管理体系,整合国内优秀的
研究者资源,健全优效特色的受试者招募网络,为日益增长
的、来自全球的临床研究提供优效的管理服务。
【CRO】【SMO】【招募】【稽查】
大田集团创立于1992 年,是国家5A 级物流企业,中国物流百
强企业。自2003年大田开始生命科学临床试验物流业务,并于
2007年建立了生命科学事业部
ArisGlobal
Booth #K04
Company Introduction
ArisGlobal has over a quarter of a century of experience
delivering regulatory compliance solutions for companies in
the life-sciences industry. We provide complete solutions from
early stage clinical trial activity to regulatory submission and
post-marketing surveillance to help companies achieve cost
efficient and effective compliance with global and regional
regulations by delivering best-in-class solutions for the specialist
functions of Pharmacovigilance/Safety, Regulatory Affairs,
Clinical Development and Medical Communications (including
medical information, medical affairs and product complaints
management). With more than half of the Global Top 50
companies included in our global customer base, ArisGlobal is
also a leading provider of cloud based and on premise solutions
with over 150 life-science companies relying on our solutions, a
hundred of which are using these solutions in our life-science
regulated and validated cloud.
Company address: TK Shin-Toshin Bldg., 6F, 1-23-1 Nishi-Shinjuku,
Shinjuku-ku, Tokyo 160-0023 Japan
Contact person: Miko Arai
Phone: +81 3 6304 5462 | Fax: +81 3 6304 5463
E-mail: [email protected]
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
参展商介绍
99
EXHIBITOR DIRECTORY
Beijing Clinical Service Center
北京科林利康医学研究有限公司
Barrington James
Company Introduction
Booth #G10
Barrington James is a global specialist recruitment consultancy
working across the Healthcare sector. Our structure, with separate
divisions and dedicated consultants for the markets we serve
ensures a thorough, professional and intelligent approach in both
permanent and interim solutions. Our tailored methodologies
include contingency database search and executive search.
With offices in Asia, the USA and Europe we have developed
an unrivalled reputation and built an extensive global network,
whilst delivering quality results to our clients. Our specialist
team of consultants, who have a combined 22 years’ experience
in the Pharmaceutical and recruitment industry, will be available
throughout the event and welcoming our existing network to our
exhibition stand, along with making new connections and building
relationships in person with those we have spoken with over the
past year. We will also be scheduling face to face appointments
that will provide you with the opportunity to discuss your
specific requirements regarding recruitment solutions for your
department/team if applicable, market intelligence and of course
your own goals and career aspirations.
Contact person: Matt Bulley
Phone: +65 6589 0589
E-mail: [email protected]
Booth # H03
科林利康,医药临床试验领域的卓越专家。
北京科林利康医学研究有限公司是一个集临床试验、药政注
册、医药写作、生物统计和数据管理、质量保证、培训和咨询
服务为己任的全方位医学科技服务商。公司通过积极参与国内
外医学领域的临床研究与学术推广,为制药企业、权威学术机
构、临床试验研究机构、专家、医生等提供临床专业化服务,
帮助患者和社会更健康。自成立以来,科林利康以优质服务和
合理的价格迅速成长为中国主要临床试验合同研究组织之一。
是美达临床数据技术有限公司的战略合作伙伴。
Beijing CTS Co., Ltd.
北京赛德盛医药科技股份有限公司
Company Introduction
Booth # E09
北京赛德盛医药科技股份有限公司,是一家专业的医药开发综
合外包服务公司,致力于为国内外医药企业提供系统、优质的
临床研究服务,立志成为临床研究领域最具影响力的公司之一。
Beijing BioKnow Information Technology Co. LTD
北京百奥知信息科技有限公司
Company Introduction
Company Introduction
Booth #J08
北京百奥知信息科技有限公司,是一家致力于为中国临床研究
提供现代化技术服务的公司。专业、专注于医药研究领域信息
整体解决方案,成为中国最领先、最全面的医药研究信息服务
商,公司获得多项认证,高新技术企业认证,ISO9001质量管理
体系认证,双软认证,超过30项软件著作权证书,超过15项国家
认可机构软件测评报告,具有完善的项目管理技术、与质量保
障体系。
公司地址:北京市海淀区大钟寺华杰大厦9B7,邮编:100098
联系人:庄永龙
电话:+86 10 8279 0315 | 传真:+86 10 8279 0317
电子邮箱:[email protected]
赛德盛秉承“尊重产品、尊重客户、尊重团队”的理念,充分
发挥人才优势,密切关注客户需求,严格遵循国际化标准操作
规程。公司人员均熟悉ICH-GCP、SFDA-GCP及国内外法规要
求,具有丰富的国内外临床研究执行及管理经验,其中核心技
术人员均具有3年以上国际多中心临床研究经验。
公司业务:CRO、SMO、WeTrail系统、培训、第三方独立稽
查及数据管理与统计业务
愿景:成为中国临床试验一站式服务平台
使命:建设临床试验综合管理系统,让中国的临床试验更高效
实现临床试验服务领域业务全覆盖
价 值 观:诚信、高效、卓越、创新
公司地址:北京市朝阳区东四环中路远洋国际中心
C座1801-1803,邮编:100025
联系人:蒋杨怡
电话:+86 186-0130-3626 | 传真:+86 10 8586 6376
电子邮箱:[email protected]
迎接法规变革,聚力专业质量
2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
100
参展商介绍
EXHIBITOR DIRECTORY
首家获得国际最高实验室质量认证——美国病理学院(CAP)
认证的独立医学实验室。为国际大型药企及全国近千家医疗机
构提供国际标准的中心实验室服务。
WS
QMS
北京经纬传奇医药科技有限公司
Beijing Jingwei Chuanqi Medicine
Services Co., Ltd.
Company Introduction
公司地址:北京市中关村生命科学园29号D101 邮编:102206
联系人:余密密
电话:+86 10 8072 0625 | 传真:+86 10 8072 0632
电子邮箱:[email protected]
Booth #E01
经纬传奇稽查(3AUDIT)是国内第一家专业医药质量第三方
稽查公司,建立了第三方稽查标准体系,通过临床研究质量稽
查、咨询和培训,提供专业客观的临床研究质量稽查报告,确
保参与临床研究的各方都能按照GCP(或ICH-GCP)、SOPs
和相关政策法规要求实施Ⅰ至Ⅳ期药物、医疗器械临床试验,
以及中药保护、安全性评价等临床研究,获得药械研发真实数
据。3AUDIT已为上百家医药企业在规范临床研究质量、注册
现场核查、注册申报多方面提供专业服务,汇聚了国内最丰富
的药械临床研究案例库。
Widler & Schiemann Ltd. ——经纬传奇全球合作伙伴
We offer Services for the Pharmaceutical/Biotech and Devices
Industry Globally:
• Audit Services (Clinical Trial Site, Affiliate, CSV, CRO,
Pharmacovigilance, Regulatory and more – GCP, GMP, GVP,
GDP & GLP)
• GxP Issue Management (GxP = GMP, GLP, GCP, GVP, etc…)
• Quality Strategy, Quality Policy & Manuals
• QMS (Quality Management System) & SOP Management,
Design & Re-engineering
• Quality by Design for Clinical Development
• Quality Risk Management for Clinical Development &
Manufacturing
• Risk Management Methodologies
• Risk-based Monitoring Design & Implementation
• Drug Safety Services
• Service Provider Assessment and Qualification
• Corporate & Functional Healthcare Compliance
• Regulatory Affairs QMS and day-to-day regulatory support
• Training on all the topics we offer
北京洛奇临床检验所股份有限公司
Beijing Lawke Health Laboratory
Beijing Lawke Health Laboratory
Center Company LTD
北京洛奇临床检验所股份有限公司
Company Introduction
Booth #A03
北京洛奇临床检验所股份有限公司(股票代码834652)是一家
集医学服务、教育、研究为一体的大型独立医学实验室。目前
服务临床及科研客户1000多家。检验所成立于2006年,是北京
Beijing Linkstart Medical Technology
Development Co. Ltd.
北京联斯达医药科技发展有限公司
Booth #C01
Company Introduction
联斯达SMO成立于2012年,国家高新技术企业,中国GCP联
盟成员,DIA中国SMO协作组副主任委员单位,是国内率先进
入互联网化管理的独立专业的临床试验现场管理组织(SMO,
Site Management Organization),具有成熟的“质量体系+
培训+IT系统”。联斯达通过临床研究协调服务和SMO现场质
量控制IT系统对临床研究现场进行精细化管理,开启线上和线
下相结合的现场质量控制模式,为服务客户反应现场真实,让
研究者和申办方对临床试验管理数据能够远程监控。
公司历经4年稳定发展成为中国知名的SMO,至今服务项目
121个,全国覆盖城市46个,拥有专业人员215人,合租机构
210个,能够覆盖各临床专业,尤其擅长内分泌、神经内科、
免疫、肿瘤等专业。联斯达坚守聚焦,一路精细化项目管理和
site点管理,我们一直在寻找更明智的伙伴与联斯达共同探讨
合作。我们立志于协助研究者规避现场管理质量风险,从而降
低申办方的研发风险。聚焦专业独立的SMO运营发展研究,致
力于成为中国临床研究现场的质量控制专家,塑造中国SMO的
价值。
公司地址:北京市朝阳区朝阳北路龙湖长楹天街西区1-1-2203
邮编:100024
联系人:艾红芳
电话:+86 10 8579 0572-808 | 传真:+86 10 8579 0572-816
电子邮箱:[email protected]
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
参展商介绍
101
EXHIBITOR DIRECTORY
Beijing S&Q Healthcare Co., Ltd.
北京松乔医药科技有限公司
Company Introduction
Booth #E08
BEIJING YINGJI LOGISTICS CO., LTD
北京映急物流有限公司
Company Introduction
Based in Beijing, Beijing S&Q Healthcare Co. ,Ltd is affiliated to
S&Q Checkup Center. S&Q focuses on subjects recruitment and
CRC service. S&Q Healthcare, with a professional recruitment
team which covers over 20 cities, could provide multi-channel
recruitment services, including physician referrals, web,
newspaper and database. S&Q Healthcare provide CRC services
to investigators and coordinate clinical trials of cardiovascular
drugs and medical devices.
北京松乔医药医药科技有限公司(简称:松乔健康)隶属于北京
松乔健康体检中心,总部位于北京,专注于受试者招募和CRC
派遣服务。松乔健康在全国主要城市拥有专业化的招募团队,
依托广阔的渠道网络及丰富的行业资源,为国内外医药企业提
供多渠道受试者招募服务,包括医师推荐、网络、纸媒及数据
库等。同时松乔健康在全国主要城市提供心血管领域的CRC派
遣服务,协助研究中心开展药物和医疗器械的临床研究工作。
Booth #F08
城市映急成立于1999年,专注医药冷链物流研发与服务。目前
公司下属60多个分、子公司,业务遍及国内800多个城市。城
市映急凭借先进的温控技术,专业的物流服务团队,强大的信
息管理平台,为各界新老客户提供精准温控运输和仓储服务。
历经十多年发展,城市映急已成为全球众多知名生物医药企业
及CRO公司首选合作伙伴。
公司地址:北京市顺义区仁和镇沙坨工业区5号,
邮编:101300
联系人:王昊
电话:+86 10 6547 1947,+86 18601072440
电子邮箱: [email protected]
Contact Person: Serena SONG (宋坤)
Phone: +86 10 5867 3117
Email: [email protected]
BioClinica
Company Introduction
Beijing Sinocro PharmaScience Co., Ltd.
北京兴德通医药科技有限公司
Company Introduction
Booth #H08
北京兴德通医药科技有限公司
(Beijing Sinocro PharmaScience Co., Ltd.),是一家经验丰
富、资源广泛的专业CRO公司。兴德通依托经验丰富的专业技
术团队、以只争朝夕的高效服务态度,凭借“因为专业,所以
敢于承担”的精神,不断赢得广大委托客户的信任与肯定,提
供与药品临床开发相关的一系列专业服务,包括产品注册、I
期至IV期临床试验、生物等效性试验和国际多中心临床试验的
监查、项目管理、受试者招募、数据管理、生物统计、翻译、
医学报告撰写、市场调研和产品开发战略咨询等。作为接受客
户委托的服务企业,兴德通本着委托客户的利益最大化为出发
点,对临床研究项目进行科学化设计、最优化管理,个性化服
务的全面解决方案,以协助委托客户节约管理成本、降低失败
风险、缩短项目周期、顺利取得各项批件与上市。使委托客户
可以集中精力与资源开拓市场,抢得市场先机。
公司地址:北京市朝阳区左家庄中街6号豪成大厦21层,
邮编:100028
联系人:梁潇
电话:+86 10 8460 5516 | 传真:+86 10 8460 5026
电子邮箱:[email protected]
Booth #B03
Bioclinica is a specialty services provider that utilizes sound
scientific expertise and proven standardized methods to create
clarity in the clinical trial process. We offer advanced medical
image analysis and comprehensive cardiac safety services to
enhance development of new therapies across all phases and
a wide range of therapeutic areas. Our therapeutically-aligned
medical and scientific teams provide unrivalled expertise and
dedicated support for clinical trials, with a focus on high-quality
data and strict regulatory compliance.
With experience spanning more than three decades and
thousands of clinical trials, Bioclinica provides the flexibility and
scalability necessary to offer tailored support for small early
phase molecular imaging studies through to large, complex,
late phase registration trials. BioClinica’s regional infrastructure
and local expertise in Asia have enabled support for the first
TQT studies in China and Japan. Through a network of offices
in the U.S., Europe and Asia, Bioclinica serves more than 400
pharmaceutical, biotechnology and device organizations –
including all of the top 20. Learn more at www.bioclinica.com.
迎接法规变革,聚力专业质量
2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
102
参展商介绍
EXHIBITOR DIRECTORY
• Specialty handling including high potent/cytotoxic and
controlled substances
• Clinical storage, distribution, and returns management.
Brightech International, LLC
布莱特及成都明科宏能临床医学研究有限公司
Company Introduction
Booth#B10
Company address: 217-221 Governor Rd. Braeside VIC 3195
Australia
Contact person: Dione Phillips
Phone: (03) 9586-1214 | Fax: (03) 9586-1299
E-mail: [email protected]
我们是您临床试验的伙伴!
成都明科宏能是一个全方位CRO公司, 在其母公司美国布莱特
的带领下以客户为中心,提供满足客户需求的、全面的、高质
量的临床监查、临床试验运作和临床试验数据服务(包括临床
试验数据管理、生物统计分析/SAS程序编写、临床试验数据标
准化)、临床试验注册申报以及医学文献撰写服务。我们还提
供中国公司进入国际市场以及国际公司进入中国市场的策略咨
询,临床申报和临床试验服务。
公司总部“布莱特”拥有平均19年的药物临床研究经验,设在
被誉为药业硅谷的新泽西州,于2009年兼并上海宏能软件,并
在香港,上海,成都设有分公司。团队拥有平均6年的药物临床
研究经验。曾负责和参与7项新药临床试验项目和10多项临床
研究项目的服务。
明科宏能拥有自己独立知识产权的CIMS(临床研究管理)系
统,包括中央随机、药品管理、数据管理、数据录入(支持
EDC和双录入)和项目管理等功能,并拥有软件开发和维护14
年的团队。CIMS系统已在中国用于200多个临床项目的研究,
在美国已用于多个项目的研究。
公司地址:中国.四川.成都高新区天府大道高新孵化园1号楼B
座C-03,邮编:610041
联系人:冉容
电话:+86 13880926290 | 传真:+86 28 8511 1480
电子邮箱:[email protected]
Catalent
康泰伦特
Company Introduction
Cenduit LLC
Company Introduction
Booth #C07
Cenduit is the Largest Interactive Response Technology (IRT)
Specialist in the World and is a joint venture between two large
organizations, Quintiles & Fisher Clinical Services.
We are dedicated to quality, partnership, efficiency, and
exemplary customer service.
Standard system functionality includes:
• Patient Randomization
• Drug Supply Management
• Drug Accountability, Returns & Destructions
• Cold Chain Management
• Consulting and Supply Chain Optimization
• Study Maintenance and Customer Service
• Global 24/7/365 Helpdesk
• Reporting and Data Integration
Cenduit has wealth of experience in randomizing patients and
managing drug supply in over 80 countries. Regardless of
study design, therapeutic area, geographic coverage, or study
complexity, Cenduit can help you manage better your trial more
effectively and efficiently. Experience of over 600 studies put to
live globally.
Booth #G05
Clinical Supply Solutions
Catalent helps solve clinical trial challenges by reliably supplying
studies of all sizes and complexities. Catalent’s commitment to
quality and service delivery excellence is evident in innovative
flexible solutions, modern global facilities, and 25+ years’
experience in supply chain management across 5,000+ studies
in more than 80 countries for innovators of all sizes.
Catalent’s offerings cover clinical trials support solutions:
• Clinical scale manufacturing, over-encapsulation, and
blinding
• Direct comparator / reference product sourcing
• Clinical packaging and labeling
• Cold chain capabilities from controlled room temperature
(CRT) to cryogenic
Latest Technology:
• User-Friendly Application = Time Saved
• Flexibility = High Performance
• State of Art Security = Peace of Mind
• Cutting-Edge Technology = Reliability
Quality:
• Cenduit’s Global Quality System is IRT-centric and riskbased, undiluted by lesser risk offerings, to assure consistent
performance over time.
• Each study has daily automated integrity checks to assure
continued compliance to protocol.
Quick Facts:
• Highly Awarded by Inc. 5000, Grant Thornton 100, and Fast
50 Award and ranked among fastest-growing privately held
companies in the U.S.
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
参展商介绍
103
EXHIBITOR DIRECTORY
Company address: 4825 Creekstone Drive,Suite 400, Durham,
NC 27703 USA
Phone: +91-99160 44055 | Fax: +91-80-3352-6600
Contact person: Sharad Gupta
E-mail: [email protected]
CCBR
CLINICAL RESEARCH
Center for Clinical & Basic Research (Beijing)
Company Limited
西斯比亚基础与临床研究中心
Company Introduction
CCBR(临床中心和基础研究中心),全球总部位于丹麦,成立于
1992年。经过20多年在世界范围内的成功运作,CCBR已经发展
为世界第一的ARO / SMO组织。CCBR提供的服务范围非常广
泛,并已广泛参与共同开发各种药品和器械。
公司地址:北京市昌平区生命园路29号中关村生命科学园创新
大厦C座一层,邮编:102206
联系人:任然
电话:+86 185 0125 1209
传真: +86 10 8070 5506
邮箱:[email protected]
Company Introduction
Company address: Suite E-10-20, Amcorp Business Suites,
Menara Melawangi, Amcorp Trade Centre, No 18, Jalan Persiaran
Barat, 46050 Petaling Jaya, Selangor Malaysia
Phone: +603 7960 5153 | Fax: +603 7932 1940
Contact person: Dr. Khairul Faizi Khalid, Head of Business
Development
E-mail: [email protected]
Website: www.clinicalresearch.my
Booth #H09
CCBR是世界领先的具有全面科学背景的临床试验现场管理组
织,专注于临床试验现场管理、病人招募和医学影像分析服务,提
高新药物开发的质量,效率和速度。CCBR已经有1200多篇论文
发表在领先的国际生命科学学术的期刊上。这个数量和频率在
所有的私营企业中都是最高的。
Clinical Research Malaysia
biotech and medical device industries) and contract research
organizations (CRO) with an extensive range of services which
include feasibility studies & investigator matching, review of
clinical trial agreements, development & placement of study
coordinators, advice & management of clinical trial budget and
improve the capability of sites.
Booth #k08
Clinical Research Malaysia (CRM) is a non-profit company wholly
owned by the Government of Malaysia’s Ministry of Health. CRM
was established in June 2012 to position Malaysia as a preferred
global destination for industry-sponsored research (ISR) and to
function as an enabler and facilitator to the industry and medical
fraternity.
CRM focuses on 5 key strategies; grow the number of principal
investigators and sites; increase the number of IndustrySponsored Research; collaborate with stakeholders; create
awareness of CRM and develop human capital.
CRM provides sponsors (primarily from the pharmaceutical,
CLINICAL
SOFT
SOLUTION FOR
SCIENCE&HEALTH
Clinical Software Co., Ltd
北京市科雷尼克软件有限公司
Company Introduction
Booth #K02
Our company is a professional clinical research information
solutions provider. The products of our company can help
customers improve the efficiency of the clinical development
process, and optimize the R & D investment. The main business:
CTMS, CRS, TSM, EDC, CDM, CODING, PV, EPRO, REPORT
我公司为临床研究信息化解决方案提供商,为各种治疗领域和
各阶段临床研究提供专业的服务。主要通过规划、管理临床试
验开发过程的各环节,帮助客户更高效的推进临床试验项目的
进程,更及时的对临床试验数据进行采集、管理、分析和制作
报表,更准确的获取临床项目分析结果,最终做到有效优化客
户的研发投资。公司产品先后为国际知名药企、世界五百强企
业、多家研究机构等提供了服务,有超过800家临床中心使用
临床试验管理平台参与试验。
公司地址:北京市海淀区西三环北路72号世纪经贸大厦B座800
邮编:100000
联系人:杜婕乔
电话:+86 139 1068 4467 | 传真: +86 10 8882 4897
邮箱:[email protected]
迎接法规变革,聚力专业质量
2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
104
参展商介绍
EXHIBITOR DIRECTORY
Clinipace Worldwide
Company Introduction
Booth #G08, G09
Company Introduction
Clinipace Worldwide is a global full-service digital contract
research organization (dCRO) that has pioneered an innovative
service model to transform drug and medical device development
by delivering technology-amplified services to improve study
performance, collaboration, and visibility across all stakeholders.
From managing your entire development program to conducting
an individual clinical trial, our experts bring extensive therapeutic
and local experience in building a well-defined clinical plan to
maximize your success. Powered by TEMPO™ – our proprietary
eClinical technology – our teams ensure your success and bring
unsurpassed efficiency, quality, and visibility to your development
programs.
Clinipace是一个提供全球性全方位服务的数字化临床研究组织
(dCRO),我们率先开拓了一个创新的服务模式,利用数字化科
技的优势,为所有的受益者提高了试验项目的效率,改善了合
作形式,并增加了试验的透明度,从而在药品和医疗器械的研
发领域带来了变革。从整体研发方案的管理到具体临床试验的
实施,我们的专家团队会利用他们广泛的治疗领域经验以及丰
富的实际临床经验建立一个完善的临床试验计划,从而最大程
度的为您的成功带来保证。借助于我们自主研发的TEMPO™电
子化临床试验平台,我们的专家团队可以确保给您的研发项目
带来高效率、高质量和高度透明化的服务,并最终确保研发方
案的成功。
Company address:
上海市黄浦区福州路318号浦汇大厦2301室, 200001
Contact person: Sophie Jia, Larry Qiu, Jason Wang
Phone: +86 21 5308 6153 | Fax: +86 21 5308 6152
E-mail: [email protected], [email protected],
[email protected]
Covance Inc.
Company Introduction
CRScube Inc.
Booth #C09
CRScube作为开发供应临床试验解决方案的专业公司,目前在
韩国市场占有率占据第一,引领着整个市场。
为助力客户成功进行临床试验,提供cubeCDMS(EDC),
cubeIWRS,
cubePRO,
cubeSAFETY,
cubeCTMS,
cubeBUILDER等综合解决方案。
CRScube作为综合临床试验解决方案供应企业,截至目前
• 在各领域,正在开展400件以上临床试验课题
• 与90多家制药公司和10家以上CRO建有合作关系
• 包括中国、法国、日本等,15000个以上各国机构,正在使
用本公司解决方案,并且有30万以上试验对象注册在系统里
与此同时,作为亚洲企业最早获得了CDISC ODM 认证,同
时拥有BSI主管的ISO9001:2008 认证和政府机构颁发的Good
software 认证等,CRScube通过获得诸类认证,旨在为客户
提供更优质的服务。
本公司解决方案可以为客户量身定制,因此,可以为贵公司提
供最适合的解决方案。
为帮助了解本公司以及解决方案,附上宣传手册,敬请参阅。
在本公司官网(www.crscube.co.kr),通过各种在线研讨,
可以获得更多有益的信息。或者通过免费试用,尝试本公司解
决方案,为贵公司推进课题用作参考。
感谢您拨冗阅读本公司介绍以及解决方案介绍,若有疑问,敬
请垂询,我们将尽心尽力为您解答 !
谢谢!
Company address: #807 R&D Tower (Nuritkum Square), 396,
Worldcup buk-ro, Mapo-gu, Seoul, 03925, Rep. of Korea
Contact person: Eric Choi
Phone: +82-70-4010-7715
Fax: +82-2-722-7280
E-mail: [email protected]
Booth # F06, F07
Covance Inc., the drug development business of Laboratory
Corporation of America Holdings (LabCorp) headquartered in
Princeton, New Jersey, USA, is the world’s most comprehensive
drug development company, dedicated to advancing healthcare
and delivering Solutions Made Real®.
Our unique perspectives, built from decades of scientific expertise
and precision delivery of the largest volume of drug development
data in the world, helps our clients identify new approaches and
anticipate tomorrow’s challenges as they evolve. Together with
our clients, Covance transforms today’s health care challenges
into tomorrow’s solutions. Information on Covance’s solutions
can be obtained through its website at www.covance.com
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
参展商介绍
105
EXHIBITOR DIRECTORY
DONNELLEY LANGUAGE SOLUTIONS
Company Introduction
Booth #K05
RR Donnelley Language Solutions is a global translation
service and technology provider. We help pharmaceutical,
clinical research and healthcare organizations create, translate,
harmonize and manage content in over 140 languages.
Thanks to +25 years of experience, 6,000 linguists, ISO certified
processes and a 24/7 service platform, we provide accurate,
secure and fast translations. Our fully scalable solutions also
include interpreting, TMS, dynamic website translation and much
more.
日新的业务范围包括:
•
新药开发与医药相关法规咨询业务
•
临床试验的规划和政策咨询
•
临床试验方案、病例报告表的设计
•
病例登录、药品随机化
•
试验监查业务
•
数据管理业务
•
统计分析业务
•
总结报告撰写业务
•
质量管理与质量保证业务
•
进口药及相关器具的药事申请业务
•
医药品市场的调查研究
•
临床试验相关培训
Company address: 22nd Floor, Nexxus Building, 41 Connaught
Road Central, Central, Hong Kong
Contact person: Christy Ma
Phone: +852-25092712 | Fax: +852-25090711
E-mail: [email protected]
ERT
Company Introduction
EPS International (China) Co., Ltd.
上海日新医药发展有限公司
Company Introduction
Booth #A11
上海日新医药发展有限公司(EPS International (China) Co.,
Ltd.)是益新国际医药科技有限公司的子公司,主要从事新药的I
到IV期临床试验的代理和药品的市场调研业务。
凭借在日本从事CRO业务二十多年的经验,和EPS集团在日
本、美国、中国大陆、中国台湾、新加坡等国家和地区的分公
司和代表处的雄厚实力,成长为国内合同研究组织行业的领军
者之一。我们基于中国,面向亚太地区,全面开展全球性的临床
研究代理业务。
上海日新医药发展有限公司是提供全领域的临床试验专业服务
的合同研究组织(CRO)。有超过100 个专业雇员,主要专业背
景有临床医学、药学、临床药理和生物统计学,并且均接受过
GCP 和临床研究的良好培训,与欧美、日本制药公司有良好的
沟通能力。迄今为止,日新完成的和正在进行的有超过 130个
临床方案和研究。试验期从 I 期到 IV 期,涉及肿瘤、心血管、
脑和神经、免疫和过敏、眼科和抗感染等方面的领域。
日新所属的EPS,是一家在日本东京证券交易所上市的企业
(上市编号 4282 ),集 CRO, SMO, IT 为一体的科技集团企
业。集团内现有员工5000余名,遍布日本,中国台湾、中国香
港、韩国、新加坡、印度、菲律宾、越南、澳大利亚、美国等
国,在专心致力于 中国 CRO 业务的健康成长的同时,决心为
顾客提供高质量服务而持续努力。
Booth #A06
ERT is the leading cloud platform solutions provider that captures
quality efficacy and safety endpoints, harmonizes data from
any clinical source system, and delivers real-time insights for
optimum trial performance – innovating better health for over 40
years and tomorrow. ERT’s combination of technology, services,
and consulting increases the accuracy and reliability of patient
data and improves the efficiency of the clinical development
process throughout the product lifecycle. ERT provides sponsors
and CROs with the most widely deployed solutions in centralized
Cardiac Safety, Respiratory, Suicide Risk Assessment, and Clinical
Outcome Assessments (COAs including patient, clinician, and
observer reported outcomes). ERT is a global organization with
headquarters in Philadelphia, PA and offices throughout the U.S.,
U.K., Japan, and Germany.
Company address: 1-19-14 Ginza, Chuo-ku Tokyo 104-0061
Japan
Contact person: Hiroshi Atago
Phone: +81 3 3561 1531 | Fax: +81 3 3561 1532
E-mail: [email protected]
迎接法规变革,聚力专业质量
2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
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参展商介绍
EXHIBITOR DIRECTORY
strategic capability and undertaking pivotal international studies.
Fountain is your trustworthy CRO Choice in Asia.
EXTEDO
Company Introduction
Booth #J10
EXTEDO is a leading solutions and services provider in the
field of Regulatory Information Management (RIM). We focus
on optimizing our clients’ eRegulatory business processes and
are the only vendor that provides solutions covering the entire
regulatory landscape. Our EXTEDOsuite combines innovation
with compliance, and quality with usability. Whether planning
& tracking, product registration, submission publishing and
lifecycle management, pharmacovigilance management and
drug safety; we optimize every eRegulatory business process.
Today, EXTEDO enables more than 35 regulatory authorities and
over 700 maintained customers across 60 countries to deliver
Effortless Compliance™.
For more information visit www.extedo.com.
Company address: Einsteinstr. 30 Ottobrunn, 85521 Germany
Contact person: Thomas Kessler
Phone: +49 89 189454 0 | Fax: +49 89 189454 999
E-mail: [email protected]
Fountain Medical Development Limited
方恩医药发展有限公司
Company Introduction
Company address: Room 301, Future Business Center 17, No. 1
Yard, Wu Li Qiao First Street, Chaoyang District, Beijing 100024
China
Contact Person: Sophia Bai
Phone: +86 22 2345 2013-8027 | Fax: +86 22 2345 2016
E-mail: [email protected]
Genuine.Consistent.Precise
GCP ClinPlus Co., Ltd.
普瑞盛(北京)医药科技开发有限公司
Company Introduction
Booth #A02
普瑞盛(北京)医药科技开发有限公司作为拥有13年历史的临
床试验服务组织,我们致力于医疗领域研发,一直努力成为研
发企业值得信赖的临床试验合作伙伴,公司本着(G)Genuine
真诚,(C) Consistent 坚持, (P) Precise 精准 的服务宗旨,以
科学、严谨、创新的精神,业务不断扩大,目前涉及药物、器
械的临床研究整个环节,可以为客户提供全方位的服务。
GCP ClinPlus Co., Ltd. is one of the leading CRO in China with
13 years history. We are dedicated to provide full service in
clinical development aiming to become the most trusted partner
with clients. We provide service based on the tenet of Genuine,
Consistent and Precise (GCP),with our business expanding ,we
can provide full service regarding the whole process of drug and
medical device development.
Booth# C03
Fountain Medical Development Ltd. is a contract research
organization (CRO) dedicated to offering a full range of ICH
GCP compliant clinical research services for multinational
clients conducting clinical research in China and East Asia. The
FMD management team has decades of combined experience
working with the world’s leading CROs and drug developers. In
the Chinese CRO market, we fill the void of a service provider
that balance high quality with moderate cost. Our extensive
global experience in multiple therapeutic areas is unmatched by
other local CROs, and our lower operational cost allows us to
pass significant savings on to our clients. We have assembled
the highest quality team that is capable of handling Regulatory
Affairs, Clinical Operations, Safety Handling, Project Management,
Data Management and Statistical Analysis, Consulting and
Pharmacoeconomic studies. Fountain has hands-on clinical trial
experiences in in mainland of China, Hong Kong, Taiwan, Korea
and the US, and has completed more than 200 clinical trial
projects, we have been in good partnership with more than 300
sites in Asia and we have enrolled more than 70000 patients in
clinical trials. Fountain’s success includes the excellent team, the
Giant Med-Pharma Service Group
北京精诚医药科技集团
Company Introduction
Booth #J04
北京精诚医药科技集团是一家提供药品和医疗器械的研发/注册/
临床试验及医药市场研究的专业服务机构。
CRO业务范围包括药品、医疗器械、诊断试剂注册/临床试验/
产品市场准入和市场研究咨询等。
SMO业务范围包括CRC/受试者招募与管理/数据录入/研究培训
等。
合作过的客户包括欧美亚及国内的各类制药及器械企业等。
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
参展商介绍
107
EXHIBITOR DIRECTORY
H&J CRO International, Inc.
北京翰博瑞强医药信息咨询有限公司
Company Introduction
Booth #E05
北京翰博瑞强医药信息咨询有限公司(H&J CRO International,
Inc.)成立于2003年,致力于全球医药研发的创新外包组织
(Contract Research Organization, CRO)。H&J总部位于享
有”全球医药研发之都”美誉的美国新泽西州(New Jersey),
中国总部位于北京CBD,同时在上海、广州、武汉、成都等15
个核心城市设有分支机构。
H&J CRO International, Inc., is a premier full service Clinical
Research Organization (CRO) offering global clinical trial
solutions. Established in 2003, and headquartered in the U.S.
in New Jersey, also has five branch offices in China in Beijing,
Shanghai, Guangshou, Wuhan, and Changdu. We specialize in
regulatory affairs, clinical trial management, data management,
SAS programming, biostatistics, and medical writing services.
Email:[email protected]
TEL: +86 10 59105001 | FAX: +86 10 59105002
ECRFPlus has established national technical support and SMO
service network with offices in major cities across China, such
as Beijing, Shanghai, Guangzhou, Wuhan, Chengdu, Hangzhou
and so on. In addition, we have established working relationship
with over one hundred of large clinical research hospitals
(sites) in China. Along with our 3Q platform suite, we are in a
superior position to offer a gateway for foreign and domestic
pharmaceutical companies to conduct clinical trials in China.
伊柯夫自2002年以来专门从事临床试验信息技术的研发,服务
于全球药厂、CROs和临床研究机构, 为他们提供符合国际标
准的临床试验信息化整体解决方案。基于其先进的SaaS平台技
术,伊柯夫为生物医药研发机构提供全过程管理、全过程数据
溯源、全方位临床试验服务平台,包括:
1. 伊柯夫3Q云服务平台: www.3QTrials.com,注重联合第
三方服务机构为药厂提供临床试验“一站式”项目管理服
务;
2. 伊柯夫SaaS数据平台:EDC、ECG、ABPM等:
www.eCRFplus.com,注重临床试验eCRF数据采集和管
理, 药物心脏毒性的研究等;
3. 伊柯夫GCP质量服务平台: www.ChinaGCPs.com, 注重
以申办方为中心的临床试验质量监督、管理和保障服务。
伊柯夫在北京、上海、广州、武汉、成都、杭州等地建立了服
务全国的技术支持和SMO服务中心,并和中国大型三甲临床医
院、I期研究基地建立了良好的合作关系, 为申办方提供优质服
务打下了坚实的基础。
公司地址:杭州市文一西路998号海创园4号楼601,
邮编:311121
联系人:金轶群
电话:+86 571 8993 6157 | 传真:+86 571 8993 6156
电子邮箱:[email protected]
Hangzhou Ecrf Technology Co., Ltd.
杭州伊柯夫科技有限公司
Company Introduction
Booth #J09
ECRFPlus, the total “e-Solution” provider for clinical trials, has
been serving global pharmaceutical companies, CROs, phase
I centers, and clinical research sites with its state-of-the-art
e-CRF+™ eClinical solution suite. Built on its eClinical technology
platform, ECRFPlus provides a truly end-to-end solution for
sponsors to help them to oversee the study progress, reduce
the study risks and shorten the overall study period. Our 3Q
platform suite includes:
1. ECRFPlus 3Q Cloud Service Platform that delivers “onestop” shop for end-to-end clinical trial management. Please
refer towww.3QTrials.com for more details;
2. ECRFPlus SaaS Platform that includes EDC SaaS for clinical
trials eCRF data capture, ECG SaaS and ABPM SaaS for drug
cardiac safety monitoring and data analysis. Please refer to
www.eCRFplus.com for more details;
3. ECRFPlus GCP Platform that promotes clinical trials quality
awareness and exchange.
Please refer to www.ChinaGCPs.com for more details.
Hangzhou Tigermed Consulting Co., Ltd
杭州泰格医药科技股份有限公司
Company Introduction
Booth #H04
杭州泰格医药科技股份有限公司(股票代码:300347)是一家
专注于为新药研发提供临床试验全过程专业服务的合同研究组
织(CRO)。我们致力为客户在降低研发风险、节约研发经费
的同时,提供高质量的临床试验服务,从而推进产品市场化进
程。
泰格医药总部位于杭州,下设33家子公司,在中国内地53个主
要城市和香港、中国台湾、韩国、日本、马来西亚、新加坡、
印度、澳大利亚、加拿大、美国等地设有全球化服务网点,拥
有近2000多人的国际化专业团队,为全球600多家客户成功开
展了500余项临床试验服务。泰格医药更因参与57余种国内创
新药临床试验,而被誉为 “创新型CRO”。
迎接法规变革,聚力专业质量
2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
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参展商介绍
EXHIBITOR DIRECTORY
IDA
Health Tech Medical Group
煌途医药集团有限公司
Company Introduction
Company Introduction
Booth #A08
煌途医药集团始于2004年,注册于香港,下设煌途医药研发(
北京)有限公司,煌途(北京)科技有限公司,思萌(中国)
有限公司,湖州思萌医药有限公司四家全资子公司,是中国本
土第一家FSP服务商,致力于提供亚太区的医药研发全职能外
包(临床研究运营、医学事务、统计与数据管理、政府与法规
事务咨询、独立稽查)、SMO等全方位服务.基于卓越的IT能
力,我们拥有独立自主研发的EDC, E-Learning, CVS, IVRS四
大系统。在过去三年,我们保持每年30%的增长,为超过30
家跨国企业提供服务。我们成为4家客户的优选供应商,签订
MSA,其中2家为跨国药厂。
Booth #H10
IDA, founded in 2004 and a member of the M3 Group since March
2015, is a Japanese company that provides consulting, CRO
and IT driven solutions that enable the optimal development
and commercialization of novel pharmaceutical products for
Japan and Asia. In the past era of FDA/EMA-oriented drug
development, IDA pioneered approaches that allowed western
biopharmaceutical companies to plan and implement Japanese
and Asian drug development fully aligned with US and European
strategies. In a new era, as Asia emerges as the world’s largest
pharmaceutical market and PMDA solidifies a position as a key
arbiter of regulatory policy for the region, IDA stands poised to
lead the way in bringing Japan and Asia to the center of drug
development.
By creatively partnering with clients throughout the entirety
of the product development and commercialization process,
IDA and the M3 Group aim to accelerate patient access to new
therapies and enhance the value of new products throughout
Japan and Asia. IDA’s main services include: 1) Market, Medical &
Regulatory Strategy /Consulting 2) Comprehensive Management
of Clinical Development (Clinical Trials In Country Caretaker &
Full-Service CRO) 3) Commercialization and Partnering Support
ICON Clinical Research (Beijing) Co Ltd
爱恩康临床医学研究(北京)有限公司
Company Introduction
Booth #F01
ICON plc is a global provider of drug development solutions
and services to the pharmaceutical, biotechnology and medical
device industries. The company specialises in the strategic
development, management and analysis of programs that
support clinical development - from compound selection to
Phase I-IV clinical studies.
With headquarters in Dublin, Ireland, ICON currently operates
from 90 locations in 37 countries and has approximately 11,900
employees. Over 2,800 of these employees are based in 13
different countries throughout Asia Pacific. Further information
is available at www.iconplc.com.
Company address: Room 1101-05, Tower B, Global Trade Centre,
No. 36 East, Third Ring North Road, Dongcheng District,
Beijing 100013 China
Contact Person: Lucy Shen
Phone: +86 135 0198 5441 | Fax: +86 21 5401 0758
E-mail: [email protected]
Company address: Selon Bldg 7F, 11-7 Shinsen, Shibuya-ku, Tokyo
150-0045 Japan
Contact Person: Benjamin Haydock
Phone: +81-3-6416-0540 | Fax: +81-3-6416-0564
E-mail: [email protected]
Quality & Transformation - New Era of Drug Development
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参展商介绍
109
EXHIBITOR DIRECTORY
for a wide range of therapeutic areas (oncology, rheumatology,
dermatology, cardiology etc.) and assessment criteria (RECIST,
Cheson, WHO etc.)
Keosys is involved in more than 50 studies with Global op 50
Pharma, Contract Research Organizations, Biotechnology &
Medical Technology companies, and Academic Institutions.
INC Research
爱恩希(北京)医疗科技有限公司
Company Introduction
Company address: 13, impasse Serge Reggiani BP 10222, 44815
Saint-Herblain, France
Phone: +33 (0) 2 53 59 12 90 | Contact person: Yifan FU
E-mail: [email protected]
Booth #C06
INC Research (Nasdaq: INCR) is a leading global contract research
organization (“CRO”) providing the full range of Phase I to Phase
IV clinical development services for the biopharmaceutical
and medical device industries. Leveraging the breadth of our
service offerings and the depth of our therapeutic expertise
across multiple patient populations, INC Research connects
customers, clinical research sites and patients to accelerate
the delivery of new medicines to market. The Company was
named “Best Contract Research Organization” in December
2015 by an independent panel for Scrip Intelligence, and ranked
“Top CRO to Work With” among large global CROs in the 2015
CenterWatch Global Investigative Site Relationship Survey. INC
Research is headquartered in Raleigh, NC, with operations across
six continents and experience spanning more than 110 countries.
KEOSYS Medical Imaging
Company Introduction
Kinetiq
Company Introduction
Kinetiq is a consulting and technology company that delivers
innovative solutions for human subject protection and
compliance in clinical research. Kinetiq works with clinical
researchers, research institutions, pharmaceutical, biotech and
medical device companies to develop contemporary approaches
to a changing landscape.
KingMed Diagnostics
金域检验
Booth #C02
Booth #H05
Company Introduction
Booth #C10
Keosysy’ flahship solution is the IMAGYS Clinical Trial Imaging
Management System (CTIMS). Imagys is a unique cloud-based
CTIMS with a fully integrated workflow and a remote viewing
system. It enables the centralization and remote assessment of
medical images during clinical trials.
金域检验创立于1994年,总部设于广州,目前在上海、香港等
全国范围内设立27个分支机构,检测项目从常规到特检已超过
2200项,为全国18000多家医疗机构提供检测服务。作为行业
标准的实践者,广州金域和上海金域分别于2008年、2013年通
过了CAP认可,并且广州金域是中国通过CAP认可检测项目最
多的医学实验室。依托于全方位高质量的临床检测技术平台,
面向国内外大型制药公司、生物技术公司和CRO提供包括实验
室检测、样本采集盒、标本物流以及标本管理等成熟的临床试
验相关的中心实验室服务。
Imagys is compatible with all medical imaging modalities and
formats, including Raw Data and Enhanced DICOM. It offers
significant advantages in terms of security, time optimization
and cost control compared to other technologies used for data
centralization. Imagys is CE-certified and FDA-cleared.
公司地址:广东省广州市国际生物岛螺旋三路10号
邮编:510005
联系人:彭淑莊
电话:+86 20 2919 3648 | 传真:+86 20 2919 6329
电子邮箱:[email protected]
Keosys is a global provider of Medical Imaging data management
solutions and central reading services for Phase I to IV clinical
trials and observational studies.
Within its international network of medical experts, Keosys also
provides image Quality Control and Central Reading services
迎接法规变革,聚力专业质量
2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
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EXHIBITOR DIRECTORY
mdgroup
Company Introduction
Kun Tuo
昆拓
Booth #K10
mdgroup are the global leader in event and delegate
management.
Booth #B05
We partner with our clients to bring global insight and expertise
alongside creativity and precision to produce unique events.
昆拓,是昆泰专为中国市场设立的合同研究组织(CRO),致
力于为中国的药物和医疗器械临床研究提供优质可靠的服务,
并为您有效控制预算。自2012年成立至今,昆拓已为多家国内
外知名制药公司提供了专业的临床研究服务,团队迅速增长。
昆拓提供的全方位临床研究服务包括:临床监查服务、项目管
理服务、医学事务服务、研究中心管理服务(CRC)、生物统
计服务、数据管理服务、注册事务服务、药物警戒服务、医学
翻译服务、临床研究人员外包服务、以及为医疗器械公司提供
的整合服务等。昆拓,优知可信,灵活善行,是您CRO服务的
信任之选。了解更多,敬请登录昆拓网站:www.kuntuo.cn。
业务联系电话:+86 21-24228633。
Our global team has a wealth of experience managing everything
from training and symposia to advisory boards and product
launches.
Company Introduction
With offices in five countries we work alongside our clients
to coordinate venue logistics, event infrastructure, tours and
excursions and use the latest technology to tailor all delegate
communications.
Through our own travel and destination management companies
we can respond quickly and flexibly to our clients whilst securing
them the best possible rates.
We’ll bring your vision to life to get the results you need.
mdgroup是全球首屈一指的活动策划者。
我们满布全球的专业团队,从培训活动、专题研讨会、咨询委
员会到产品发布会,都具有丰富的管理经验。
LORENZ Life Sciences Group
Company Introduction
Booth #K07
LORENZ Life Sciences Group (www.lorenz.cc) has been
developing and marketing software solutions for the Life
Sciences market since 1989. LORENZ’s solutions are geared
specifically for submission assembly, review, publishing,
validation and management. LORENZ docuBridge® is the most
widely used eCTD submission management system for U.S.,
European and Japanese formats among many others, and is
popular with regulatory agencies and industry alike. With over
500 installations in over 25 countries, LORENZ has a strong
worldwide customer base.
Company address: Building 329, Doncastle Road, Bracknell,
Berkshire, RG12 8PE, United Kingdom
Contact Person: Catherine WONG
Phone: +65 9827 7300
Fax: +44 1344 420 686
E-mail: [email protected]
Quality & Transformation - New Era of Drug Development
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参展商介绍
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EXHIBITOR DIRECTORY
Medidata
Company Introduction
Booth #F04, F05
Merge, an IBM Company
Company Introduction
Booth #H02
Medidata is the leading global provider of cloud-based solutions
for clinical research in life sciences, transforming clinical
development through its advanced applications and intelligent
data analytics. The Medidata Clinical Cloud® brings new levels
of productivity and quality to the clinical testing of promising
medical treatments, from study design and planning through
execution, management and reporting. We are committed
to advancing the competitive and scientific goals of global
customers, which include over 90% of the top 25 global
pharmaceutical companies; innovative biotech, diagnostic and
device firms; leading academic medical centers; and contract
research organizations.
About Merge eClinical
The eClinical division of Merge Healthcare, an IBM Company,
is a leading provider of cloud-based software solutions for
the clinical research industry. Our flagship products include
eClinicalOS (eCOS) and CTMS for Investigators (CTMSi). eCOS
is a single, scalable platform that allows Sponsors, CROs, and
academic researchers to capture and manage clinical data with
ease. CTMSi is a comprehensive clinical trial management system
that helps site professionals organize and centralize the study
management process.
Medidata 是全球领先的基于云解决方案供应商,通过其先进
的应用和智能数据分析为生命科学的临床研究和临床发展改革
提供大力支持。Medidata Clinical Cloud™ 为极具前景的医疗
治疗临床试验带来了更高的生产力和质量水平,从研究设计、
计划直至执行、管理和报告。我们致力于推动全球客户的竞争
力和科学目标发展,其中包括:90% 以上的 25 强跨国制药公
司;创新的生物技术、诊断和医疗器械公司;领先的学术医疗
中心以及合同研究机构。
Merge 电子临床简介
Get more information at www.eclinicalos.com.
Merge Healthcare(一家 IBM 公司)的电子临床部是临床
研究行业中基于云的软件解决方案的领先提供商。我们的旗
舰产品包括电子临床操作系统(eClinicalOS,eCOS)和研
究人员专用 CTM (CTMSi)。eCOS 是一个单一的可扩展平
台,允许申办方、合同研究组织 (CRO) 和学术研究人员轻松
获取和管理临床数据。CTMSi 是一个全面的临床试验管理系
统,帮助研究单位专家实现研究管理过程的组织化和集中化。
在 www.eclinicalos.com 上了解更多信息。
Company address: 4000 Aerial Center Parkway, Morrisville, NC
27560 USA
Phone: +1 (919) 653 3663 | Fax: +1 (919) 653 3620
Contact person: Scotti McConnell
E-mail: [email protected]
MedXview Inc
益赛仕国际信息技术(北京)有限公司
Company Introduction
Booth #C05
eCentral™ -- 全球药品认证信息管理系统
基于国际最新标准eCTD,全球唯一的,完全成熟的,满足所有
药品认证需求的信息管理平台。
MedXview软件
是不分国界,支持多语言,跨平台。从始至终不间断信息处
理。
是经历十多年的客户密切配合、精心研究开发而成。是知识与
经验的结合。可以帮助国内外药厂,从数据采集,质量控制,
到文档的修改,存储,申批,及最后通过各国政府的认证批
准,提供了一体化最佳解决方案。并已成功的应用到美国与欧
洲的医药领域中。
Meso Scale Diagnostics, LLC
Company Introduction
Booth #A07
Meso Scale Discovery (MSD®) is a leader in high performance,
multiplex-enabled biomarker assays for cytokines, toxicology,
neurodegeneration and metabolic disease research, used
by leading biopharmaceutical and academic researchers
in human and animal model studies. MSD’s proprietary
electrochemiluminescence (ECL) platform delivers exceptional
sensitivity, wide dynamic range and rapid turnaround. For more
information, visit www.mesoscale.com.
迎接法规变革,聚力专业质量
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参展商介绍
EXHIBITOR DIRECTORY
太美医疗系统
MobileMD System
MobileMD System Co., LTD
嘉兴太美医疗科技有限公司
Booth #G06
Company Introduction
太美医疗系统致力于移动互联网技术在临床研究和药物安全领
域的应用,在行业中率先推出全新一代、基于云计算和移动技
术的数据解决方案,基于SaaS的服务模式,全面提升新药研发
效率与质量,并降低研发成本。太美医疗系统已上市的产品包
括
临床研究产品线:
• eCollect® (电子数据采集系统,EDC),
• AIMS® (临床试验管理系统,CTMS),
• eBalance® (基于网络应答系统,IWRS),
• eReport® (电子患者报告结局系统,ePRO),
• eRecord® (专科电子病历,SEMR),
和药物警戒产品线:
• eSafety® (药物安全性管理系统,PVS)等。
太美医疗系统已经与众多国际、国内顶级医药企业及合同研究
组织(CRO)开展合作。未来,太美将继续致力于打造世界级
的医疗数据交互平台,引领全球临床研究和药物安全领域技术
发展潮流。
NNIT’s main service:
• Compliance consulting and validation of pharmaceutical
industry
• Clinical trial management platform
• IT strategic consulting
• SAP consulting, implementation and maintenance
• Solution development
• IT infrastructure service
NNIT-致力于生命科学的IT合作伙伴
NNIT是丹麦领先的IT咨询服务公司,致力于运用IT技术解决生
命科学行业的各种复杂挑战。过去的二十年,我们将最先进的
技术应用于软件开发,业务流程和多方沟通中,我们全方位的
解决方案帮助客户提高运营效率,同时实现企业的经营目标。
我们的客户遍布制药、食品、制造、金融、交通和公共设施等
行业。
今天,NNIT在全球拥有五个分公司,超过2500名员工。中国
分公司是NNIT丹麦境外最大的交付中心。自2006年成立以
来,中国分部已飞速发展为一家规模超过700人,实力超群的
公司。
我们的服务涵盖:
• 制药行业合规咨询和验证
• 临床试验管理平台
• IT战略咨询
• SAP咨询实施和运维
• 解决方案开发
• IT基础架构服务
公司地址:襄阳北路97号襄阳大楼716室,邮编:200031
联系人:万韫鋆
电话:+86 13671980684
电子邮箱:[email protected]
Novotech Shanghai Limited
诺佛葛医药咨询(上海)有限公司
NNIT (Tianjin) Technology Co. Ltd.
天津恩恩科技有限公司
Company Introduction
Company Introduction
Booth #F09, F10
NNIT-Your dedicated IT partner in the life sciences
industry
NNIT is one of Denmark’s
leading consultancies in IT
development, implementation and operations. For over a decade,
we have applied the latest advances in technology to make
software development, business processes and communication
significantly more effective. Our customers are in the fields of
pharmacy, food, manufacturing, finance, transportation and
public facilities.
Today, NNIT has more than 2,500 employees. Our China office
is NNIT’s largest delivery center outside Denmark. The more
than 700 people strong company has grown rapidly since it was
established in 2006.
Booth #E10
Established in 1996, Novotech is Australia’s largest independent
CRO, headquartered in Sydney, with operations in New Zealand,
China, Hong Kong, India, Malaysia, the Philippines, Singapore,
South Korea, Taiwan and Thailand. Novotech’s service offering
has come to be recognized for its quality both by our clients, as
well as industry analyst groups. In addition, we offer worldwide
reach to our clients through key external partnerships and
strategic alliances, with partners in the US, Canada, Europe, and
China.
Novotech is one of the few organisations in the industry that
have secured accreditation with the International Standards
Organisation (ISO), what this means for our customers is that you
can expect at a minimum, a structured, professional approach to
all phases of your project management with us. Ranging from
administrative requirements, contract and operational issues
through to reporting and communication needs.
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EXHIBITOR DIRECTORY
Novotech’s key strength is our people. We’re committed hiring
experienced professionals with local environment expertise.
Both in Australia and internationally Novotech boasts some of
the most experienced Project Managers and CRAs in the industry,
our vision to be recognized as the Asia Pacific CRO of choice, is
a goal we get closer to reaching every day.
Company address: 6th floor, 21st Century Building,
No.210 Century Avenue, Pudong, Shanghai 200120
China(上海市浦东新区世纪大道210号21世纪大厦6楼)
Contact Person: Alex Ling(凌晓烨)
Phone: +86 159 2123 6576 | Fax: +86 21 5172 0966
E-mail: [email protected]
Ogrin Partner Consulting Ltd.
北京欧格林咨询有限公司
Company Introduction
Booth #J06
作为领先的临床试验整体服务提供商,北京欧格林咨询有限公
司成立于2005年,是亚洲领先的整体人才管理服务提供商——
科锐国际集团全资子公司,首批获得医学研究和劳务派遣经营
许可资质的公司,在亚太区拥有超过60个分支机构。在过去的
一年中,欧格林为企业成功派遣的人才超过20000人次。
NTT DATA CORPORATION
株式会社 NTT DATA
Company Introduction
Booth #H01
NTT DATA, one of the major subsidiaries of NTT Group, is the
biggest system integrator in Japan. According to our company’s
group vision , “Global IT Innovator”, we provide broad range of
IT services and solutions for public, financial, manufacturing,
telecommunications and healthcare/life sciences sectors by
more than 75,000 professionals in more than 35 countries.
NTT DATA is a strategic partner delivering DATATRAK product
suite, DATATRAK ONE[TM], providing an end-to-end clinical
enterprise solution for efficiently designing, delivering and
managing clinical trials. We provide full support of DATATRAK
ONE[TM], including sales of licenses, consulting service of
implementation, training seminars and operations.
NTT DATA 是 日本NTT电信的子公司,是日本最大的系统集成
商。NTT DATA 树立了成为“全球IT创新企业”的目标,在35
个国家有近75,000名专业人员在公共,金融,生产,电信,
医疗保健科学等领域提供解决方案的服务。
NTT DATA是DATATRAK产品系列的供应商,战略伙伴。
DATATRAK ONE[TM] 包含所有有关临床试验的医疗解决
方案,且实现了临床试验数据管理的高效率的设计,控制与
管理。我们提供 DATATRAK ONE[TM]的整套服务,包括
licenses的销售,咨询服务的提供,系统设计培训,系统操作
培训等。
OmniComm Systems, Inc.
Company Introduction
Booth #H07
As the EDC specialists OmniComm understands the power
that an information-driven clinical enterprise can bring to your
clinical research organization. OmniComm is the only company
that provides a choice of best-of-breed EDC platforms purposebuilt for Early Phase, Late Phase, Phase I-IV, device trials, and
Investigator Initiated. OmniComm provides the most advanced,
open and interoperable EDC platforms. Through our innovative
cloud technology and advanced API web services we provide
you with information to make insight driven, clinical data based
decisions; bringing medical therapies to patients faster with lower
risk. We invite you to learn why 4 of the 5 top CROs and 7 of the
10 largest Phase I Clinics run OmniComm EDC technologies.
Company address: 2101 W Commercial Blvd. Ste 3500, Fort
Lauderdale, FL 33309 USA
Contact Person: Feng Cheng
Phone: 954 473 1254
E-mail: [email protected].com
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参展商介绍
EXHIBITOR DIRECTORY
PPD
Oracle Health Sciences
甲骨文 健康科学
Company Introduction
Company Introduction
Booth #K03
Oracle Health Sciences leverages industry-shaping technologies
that optimize clinical R&D, mitigate risk, advance health care, and
improve patient outcomes. Oracle uniquely enables life sciences
organizations to innovate, develop, manufacture, and successfully
market new products while managing risk, ensuring regulatory
compliance, and optimizing return on investment. Oracle
delivers key functionality built specifically for pharmaceutical,
biotechnology, clinical research, and medical device enterprises.
Comprehensive, preintegrated business applications and
technology accelerate value from streamlining core processes
and flexibly managing large volumes of information needed for
product development/approval and business decision-making.
Booth#J02
PPD is a leading global contract research organization providing
comprehensive, integrated drug development, laboratory and
lifecycle management services. Our clients and partners include
pharmaceutical, biotechnology, medical device, academic and
government organizations. With offices in 46 countries and more
than 15,000 professionals worldwide, PPD applies innovative
technologies, therapeutic expertise and a firm commitment to
quality to help clients and partners bend the cost and time curve
of drug development to deliver life-changing therapies that
improve health.
For further details please visit our website: https://www.oracle.
com/industries/health-sciences/index.html
PRA Health Sciences
PAREXEL CHINA CO., LTD
精鼎医药研究开发(上海)有限公司
Company Introduction
Company Introduction
Booth #F02, F03
PAREXEL International Corporation is a leading global
biopharmaceutical services organization, providing solutions
across the drug development and commercialization spectrum
that expedite time-to-market and peak-market penetration.
PAREXEL has developed significant expertise right from drug
development and regulatory consulting to clinical pharmacology,
clinical trials management, medical education and reimbursement.
For over 30 years, we have helped clients get their new and
innovative drug treatments into the hands that need them most
by simplifying their journey to market. Headquartered near
Boston, Massachusetts, PAREXEL has offices in 77 locations in
51 countries around the world and had approximately 18,200
employees in the second quarter. For more information about
PAREXEL International, visit www.PAREXEL.com.
Company address: 20F, Taiping Finance Tower, No. 488, Middle
Yincheng Rd., Pudong Shanghai China
Phone: +86 21 5111 8000
E-mail: [email protected]
Booth#A04
PRA Health Sciences delivers innovative drug development
solutions that improve patients’ lives. Our people love what they
do, working tirelessly for clients across all phases and therapeutic
areas. With 12,000+ employees covering 80+ countries, we
provide an impressive global presence and in-depth knowledge
of local regulations, standards of care and cultural customs.
PRA’s Strategic Solutions division maintains a sole focus on
delivering practical, customized solutions that seamlessly
enhance our clients’ infrastructure. Our unique Embedded
Solutions™ model provides people, processes, systems and
expertise to efficiently develop internal product portfolios,
enhance quality and improve efficiency, while sponsors maintain
strategic control.
Company address: Room 2308-2318, 23F, Tower B, Gemdale
Plaza, No.91, Jianguo Road, Chaoyang District, Beijing, 100022,
P.R. China
E-mail: [email protected]
Quality & Transformation - New Era of Drug Development
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参展商介绍
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EXHIBITOR DIRECTORY
Project Management Institute (PMI)
项目管理协会(PMI)
Company Introduction
Booth#B04
PMI是项目、项目集、项目组合管理领域中全球领先的非营利
会员制协会。通过全球宣传、合作、教育与研究,PMI为全球
超过290万名专业人士创造价值。PMI提供9种认证,其中项目
管理专业人士 (PMP®)、敏捷管理专业人士(PMI-ACP®)、
商业分析专业人士(PMI-PBA®)资质认证是项目管理领域全
球通用的权威认证,也是世界许多500强企业的首选。
公司地址:北京市朝阳区太阳宫中路12A号太阳宫大厦11层
1107室,邮编:100028
联系人:叶慧婷
电话:+86 10 8429 9191 | 传真:+86 10 8429 9292
电子邮箱:[email protected]
Q2 Solutions
Company Introduction
Booth#H06
Launched in 2015, Q2 Solutions is a global clinical trials
laboratory services organization that helps biopharmaceutical,
medical device and diagnostics customers improve human
health through innovation that transforms science and data
into actionable medical insights. Q2 Solutions is an innovative,
progressive and responsive partner with the quality focus, global
experience and deep scientific and medical expertise integral to
drug, medical device, and diagnostic development. Q2 Solutions
is a joint venture formed by Quintiles and Quest Diagnostics
combining the clinical trials laboratory services of each parent
organization. To learn more, visit www.q2labsolutions.com
QIAGEN (Suzhou) Translational Medicine Co., Ltd.
凯杰(苏州)转化医学研究有限公司
Booth#K06
Company Introduction
QIAGEN (Suzhou) Translational Medicine Co., Ltd. (“QIAGEN
(Suzhou)”) is an innovative company that provides complete
solutions for precision medicine. With a state-of-the-art facility
equipped with the most advanced technologies and platforms as
well as committed talents, QIAGEN (Suzhou) offers our partners
with fully integrated solutions from biomarker discovery and
lab testing development, patient stratification by molecular
testing during clinical trials, to companion diagnostics (CDx) kit
development and all the way to commercialization. Based on
QIAGEN’s advanced technology, and through our knowledge
and experience in translational medicine, we sincerely hope to
work with you to accelerate the rate of clinical development
of innovative medicine to make personalized healthcare and
improvement in life possible.
凯杰(苏州)转化医学研究有限公司是一个为精准医疗提供完
整解决方案的创新型公司。凭借QIAGEN领先的仪器、试剂以
及强大的技术团队,凯杰(苏州)能够为我们的合作伙伴提供
从生物标志物的发现和检测方法开发、到新药临床试验病人分
子检测和入组筛选,以及伴随诊断试剂盒开发和商业化的一站
式服务。我们希望与您携手,通过凯杰先进的核酸和蛋白诊断
技术,运用我们的转化医学知识和经验,加速新药临床开发的
节奏,为中国待解决的医疗需求提供个体化诊疗解决方案。
公司地址:中国苏州工业园区星湖街218号B5楼9楼
邮编:215123
网址:www.transmedchina.com
Quintiles
Company Introduction
Booth#B06, B07
从对科研、治疗及分析领域专业知识的深入洞察到卓越交付,
昆泰能够帮助生物制药公司和其他医疗保健公司提高从产品研
发到上市中每一步的成功概率。从咨询到实际运行,昆泰是全
球最大的健康产品研发和综合医疗健康服务供应商。 昆泰的服
务还涉及产品的商业化和观察性研究。昆泰在全球约100个国
家有团队为客户提供服务,是财富500强之一,并入选财富杂
志“全球最佳声望企业”名单。如需了解更多详情,敬请访问
我们的网站:www.Quintiles.com 。
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参展商介绍
EXHIBITOR DIRECTORY
Quintiles (NYSE: Q) helps biopharma and other healthcare
companies improve their probability of success by connecting
insights from our deep scientific, therapeutic and analytics
expertise with superior delivery for better outcomes. From
advisory through operations, Quintiles is the world’s largest
provider of product development and integrated healthcare
services, including commercial and observational solutions.
Conducting operations in approximately 100 countries, Quintiles
is a member of the FORTUNE 500 and has been named to
FORTUNE’s list of the “World’s Most Admired Companies.” To
learn more, visit www.quintiles.com.
R&G PHARMASTUDIES CO LTD
诺思格(北京)医药科技股份有限公司
Company Introduction
Booth#E07
abundant experience in all types of clinical trials through Phase I
to Phase IV including a vast array of therapeutic areas.
Rundo’s headquarters is in Shanghai with a branch located in
Beijing, representative offices in Guangzhou and Yangzhou and
a subsidiary Biometrics centre in Nantong. Beyond this, Rundo
has agencies and home-based staff in more than 20 provinces
around China.
Being at the forefront of the clinical trial industry, Rundo provides
its Sponsors with high quality services compliant with ICH-GCP,
CFDA-GCP and other related regulations. By virtue of its own
strength and recognition from Sponsors, Rundo has become one
of the leading CROs in the Chinese CRO industry. Our business
has already extended outside the China market and in to the rest
of Pac-Asia as well as Europe and America.
公司地址:上海市黄浦区汉口路266号申大厦18楼 ,
邮编:200001
联系人:黄佳文
电话:+86 21 5108 0001-8605 | 传真:+86 21 5108 0010
电子邮箱:[email protected]
诺思格(R&G)成立于2008年,是国内专业领先,规模最大的
临床合同研究组织(CRO)之一。诺思格目前有2个全资子公
司,分别是专注于SMO的圣兰格(SMS)和专注于数据管理统计
分析的艾迪斯(IDS)。诺思格现有630余人的专业团队,覆盖
国内35余个城市,亚洲6个国家和地区,已与超过200余家研究
机构,450余家医院及600多个科室合作,目前已为260多个国
内外制药/生物技术/医疗器械客户提供专业化的服务。诺思格
正在筹备上市工作,将一直坚持诚信高效的服务理念,用心做
事,努力成为客户信赖,社会尊重的国际化一流企业。
公司地址:北京市海淀区车公庄西路19号华通大厦
B座北塔11层,邮编:100048
联系人:张辉
点话:+86 10 8801 8650
传真:+86 10 8801 9978
电子邮箱:[email protected]
SF Cold Chain
顺丰冷运
Company Introduction
Booth#K09
1993年,顺丰诞生于广东顺德。自成立以来,顺丰始终关注于
服务质量的提升、持续加强基础建设、积极研发和引进具有高
科技含量的信息技术与设备以提升作业自动化水平,在国内外
建立了庞大的信息采集、市场开发、物流配送、快件收派等速
运业务机构及服务网络。
近几年,互联网及相关行业快速发展,顺丰速运从单一快递服
务商向顺丰服务转型,致力于成为平台型企业。
2014年9月25日,顺丰速运推出顺丰冷运(SF Cold Chain),
利用顺丰航空、陆运、仓储等资源优势,整合顺丰现有门店、
网点及末端配送资源,为食品和医药行业客户提供专业、安
全、全程可控的冷运服务。
Rundo International Pharmaceutical Research &
Development Co., Ltd.
润东医药研发(上海)有限公司
Company Introduction
Booth#B08, B09
Rundo International Pharmaceutical Research & Development
Co., Ltd. (Rundo) founded in 2004, is a full-service CRO with
强大的空中、地面运输网络,33座B2C仓储服务冷库,专业的
温控技术以及先进的系统管理能力,致力于建设标准化、规范
化的冷运网络,提供高品质、高效率的冷运供应链服务,为客
户、为社会创造价值,传递健康,建立冷链运输与供应链行业
新标准,开创顺丰服务全新时代。
公司网址:www.sf-express.com
公司热线:95338
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
参展商介绍
117
EXHIBITOR DIRECTORY
艾迪康是目前国内唯一一家中心实验室检测和临床检验业务在
体系、仪器、人员、系统上完全独立分开管理的检验机构,充
分保证药物临床试验的检测质量,协助申办者和研究者客观地
完成药物临床试验和新诊疗手段研究。
联系方式:021-64773153
SG Research International
Company Introduction
Booth#G01
SG Research International (SGRI) with offices in Wyckoff, NJ
and Beijing, China was founded in 2006 and is owned and
managed by Stephen Gilbride. He has more than twenty years of
experience in the Pharmaceutical Industry and holds a Master’s
Degree in Drug Regulatory Affairs.
SGRI has a talent network of seasoned and regionally-based
GxP auditors with backgrounds in the Global Pharmaceutical
and Biotech Industries as well as with Regulatory Authorities.
They are positioned to leverage their broad range of experience
to reduce risk in clinical trials. All SGRI Auditors are 100%
independent.
Our goal is your success. We are uniquely positioned to offer
you customized solutions to your clinical research challenges.
We offer professional services with competitive pricing. We
are driven to deliver solutions to our clients with Quality
and Efficiency. We can help protect as well as optimize your
investment.
We are committed to matching talented and experienced clinical
research professionals with the needs of our clients.
Shanghai ADICON Central Laboratory
上海艾迪康中心实验室
Company Introduction
Booth#E06
上海艾迪康中心实验室是艾迪康医学检验集团专为中国药物临
床试验设立的独立的检验机构。致力于为在中国开展的药物临
床试验提供及时有效、客观可靠、完整可溯源的实验室检查数
据。
中心实验室成立于2006年,2008年获得美国病理家学会
(CAP)、计量认证(CMA)和糖化血红蛋白标准化计划一级
证书(NGSP level 1),并通过复评审。中心实验室设有血尿
常规、生化、免疫(仪器免疫、手工免疫、放射免疫)、分子
生物学、微生物、病理、遗传、研发等14个专业组。
Shanghai Jsure Health Co., Ltd.
上海捷信医药科技股份有限公司
Company Introduction
Booth #C04
Jsure is the leading patient recruitment organization (PRO) in
China. We provide reliable service raging from feasibility study,
patient recruitment, patient retention, CRCs deployment .With
multiple channels, Jsure has helped over 30 studies every year to
recruit thousands patients and assist sponsors to speed up their
trial progress. Jsure has formed the unique PRO+CRC one stop
service model to improve both speed and quality of a clinical
trial. Jsure co-founded Asian patient recruitment organization
(APRO) in 2014 to meet the increasing demand of Clinical Trials
in Asia. Drug finder—— a new drug information platform created
by Jsure. The consolidated new drug information can be exposed
as a service to the public, promote patients’ education, increase
treatment efficacy, reduce health risks, relieve patient ‘ s burden,
We are committed to protecting human health.
捷信是目前中国最具特色的临床研究服务公司之一。依托强大
的服务网络,捷信为申办方/CRO公司提供临床研究前期调研、
临床研究患者招募、临床研究协调员(CRC)派遣及临床研究患
者维系服务,捷信是中国领先的患者招募服务提供商,并率先
在中国建立一支规模最大、最专业的临床研究患者招募团队,
创新使用媒体,并结合自有患者数据库和专业呼叫中心, 每年
为数十项研究招募几千名患者。 2014年,捷信健康牵头组建
APRO(亚太患者招募联盟),以满足日益增长的亚太区临床
项目需求。目前捷信健康凭借完善的质量管理体系,高效的服
务与30余家领先的跨国制药企业保持密切合作关系,其专业程
度已得到行业广泛认可。2015年,捷信自主创建和运营新药咨
询平台——找药神器,联接严重疾病患者和医疗解决方案之间
的桥梁,为社会提供新药资讯与患者教育服务,提高疾病诊疗
效率,降低健康风险,减轻患者负担,维护人类健康。
Company address: 9F, Block G, 315 West Guangyuan Road,
Shanghai 200030 China
Phone: +86 15000267826 | Contact person: Ady He
E-mail: [email protected]
迎接法规变革,聚力专业质量
2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
118
参展商介绍
EXHIBITOR DIRECTORY
Shanghai MUDI Biotech Co., Ltd.
上海妙一生物科技有限公司
Booth#J05
Company Introduction
“药研社”专注于医药研发行业,是汇集研发资讯、临床数
据库、研发工具和行业沟通的专属互联网平台。希望能众筹
行业之力来分享与共享资源,为医药研发、临床研究相关人
员节约时间、提高效率。“药研社”旗下产品包括“药研
社”APP、“药研发”微信公众号、患者随访工具等,成为行
业小秘书是药研社的最高愿景和奋斗目标。
公司地址:上海市闵行区七莘路1839号财富108广场北楼26层
邮编:201101
联系人:谢洋
电话:+86 21 6083 3527 | 传真:+86 21 6083 3527
电子邮箱:[email protected]
Shanghai Shengsheng Logistics Co., Ltd
上海生生物流有限公司
Company Introduction
Booth#J01
生生物流专注于为生命科学、生物技术、药物研发等领域的客
户提供安全、专业、高效的冷链物流解决方案。
生生总部位于上海,在北京、广州、天津、南京、武汉、西
安、成都、重庆、长春均设有区域服务中心,在全国70多个城
市有经过我们专业培训的冷链物流专员,能为您提供全国范围
内24H-48H送达的门对门高端冷链物流服务。
生生在上海总部建有可容纳100万支1.5mlEP管的生物样本库以
及可容纳80m³的药品冷藏库,可为您提供生物样本储存管理和
临床试验药品储存配送服务。
Shanghai Pharmaceutical ZhongXie Co., Ltd.
上海医药众协药业有限公司
Company Introduction
Booth#C08
上海医药集团股份有限公司在2014年中国企业500强中综合排
名位居全国医药行业第二。
上海医药众协药业有限公司隶属于上海医药集团股份有限公司
下属全资子公司上海医药分销控股有限公司,公司在临床试验
服务上具有丰富的经验,可根据客户需求提供专业的供应链配
套服务,从药品采购,冷链储存配送,二次分装,到其他增值
服务,包括进出口服务,医疗废弃物回收。公司在全国范围内
拥有通过GSP验证的仓储及配送网络,满足了临床试验用药的
高时效性和及规性。
Shanghai Pharm ranked 2nd in pharmaceutical industry among
China’s Top 500 companies 2014. Shanghai Pharmaceutical
Zhongxie Co., Ltd. is a subsidiary to Shanghai Pharmaceutical
Co., Ltd, which is wholly owned by Shanghai Pharm. Zhongxie
has reach experience in providing clinical trial related services,
incl. drug purchase, cold-chain logistics, re-packaging, and other
value-added services, such as import & export, and medical
waste disposal. Zhongxie has passed GSP authentication for
warehousing and logistics nationwide, to fully ensure efficiency
and compliance in providing clinical trial services
公司地址:上海市徐汇区龙华中路600号绿地中心B座19楼
联系人:夏贤雯
电话:+86 21 3209 6606*8607 | 传真:+86 21 3230 3792
电子邮箱:[email protected]
Shengsheng logistics is focused on provide a safe, professional
and efficient logistics solutions for life science, biotechnology
and biopharmaceutical companies.
Shengsheng is headquartered in shanghai with offices in Beijing,
Guangzhou, Tianjin, Nanjing, Wuhan, Xi’an, Chengdu, Chongqing
and Changchun. Our professional operators cover more than 70
cities and provide China nationwide high quality and door to
door cold chain logistics service within 24 to 48 hours.
Our warehouse in shanghai for bio-sample and clinical trial drugs
can accommodate one million 1.5ml samples and 80 cubic meter
drugs, and providing the storage and distribution service for biosample and clinical trial drugs.
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
参展商介绍
119
EXHIBITOR DIRECTORY
Springer Nature
施普林格 • 自然集团
Company Introduction
Shanghai Yaoshangfei Biologicals Cold Chain
Logistics Co., Ltd
上海耀尚飞生物制品冷链物流有限公司
Company Introduction
Booth#G04
【我们的愿景】
持续提供专业化、个性化、品质化的生物制品一站式冷链物流
服务;致力成为行业领先的专业冷链物流公司为国内外客户提
供安全迅速定制化服务;致力承担更多企业社会责任。
【核心价值观】
客户至上,致力满足超越客户期望;
匠心精神,用心做事,脚踏实地,精益求精;
追求卓越用心付出严格执行努力达到最优品质。
公司地址:上海市浦东新区张江路1238弄恒越国际大厦1号楼
一层B、C、D座,邮编:201203
联系人:赵一恺 / 周志麟
电话:+86 13816964470 / 15900904590
传真:+86 21 5269 5671
电子邮箱:[email protected]; [email protected];
[email protected]
施普林格 • 自然集团(Springer Nature)是一家全球领先的从
事科研、教育和专业出版的机构。集团旗下汇聚了一系列备受
尊敬和信赖的品牌,以各种创新的产品和服务,为客户提供优
质的内容。施普林格 • 自然集团是世界上最大的学术书籍出版公
司,还出版全球最具影响力的期刊,也是开放研究领域的先行
者。集团在全球约有1.3万名员工,遍及50多个国家,年营业额
约15亿欧元。施普林格自然在2015年由自然出版集团、帕尔
格雷夫麦克米伦、麦克米伦教育、施普林格科学与商业媒体
合并而成。更多信息,请访问www.springernature.com
TransPerfect Translations International Inc.
Company Introduction
SMO Clinplus Co., Ltd.
普蕊斯(上海)医药科技开发有限公司
Company Introduction
Booth#A01
普蕊斯(上海)医药科技开发有限公司是中国SMO行业的领军
企业,致力于提供最高端的SMO服务,我们通过覆盖全国58
个城市的将近400名常驻site员工,大量的医院资源及长期积累
的合作关系,以及创新驱动的战略,将行业标准不断创新并提
高。
公司地址:上海市黄浦区九江路333号金融广场2204-2206室
邮编:200001
联系人:侯颖萍
电话:+86 18911101063
电子邮箱:[email protected]
Booth#A05
Booth#A10
TransPerfect is the largest pharmaceutical translation firm
worldwide and has over a 20 years of experience in the
pharmaceutical arena. TransPerfect provides a full array of
services to support all the language needs of life sciences
organizations. Our next-generation approach centers around
innovation, combining cutting-edge workflow technologies with
the industry’s only quality management system fully certified to
EN 15038:2006 and ISO 9001:2008. Whether it’s the translation
of Informed Consent Forms, over-the-phone interpretation
for patient consultations, e-learning courses or IVR prompt
recordings, we will customize our production processes to best
serve you.
Learn more about TransPerfect here: https://www.transperfect.
com/index_lifescience.html
Company address: Suites 1704-5 Universal Trade Centre, 3-5A
Arbuthnot Road Central, Hong Kong S.A.R.
Contact: Wei Du
Phone: +86 21 6266 6880 * 105 | Fax: +86 21 6266 6880 * 118
E-mail: [email protected]
迎接法规变革,聚力专业质量
2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
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参展商介绍
EXHIBITOR DIRECTORY
Trifecta
Company Introduction
Booth#G03
Trifecta is a leading global clinical technology solutions provider,
producing more than 350 live, on-demand and web-based
Investigator meetings each year in 91 countries. Trifecta’s
pioneering innovative training and portal solutions improve trial
quality, speed study start-up and Site readiness, and improve
workflow and communication between Sites, Sponsors and
CROs.
Easily integrating into your existing processes, Trifecta solutions
allow clients to immediately realize significant benefits while
minimizing disruption to the organization. Trifecta provides
innovation, globalization and execution for projects of any size
around the world.
Office locations: Los Angeles - Indianapolis - Philadelphia Cambridge, UK - Prague, Czech Republic - Yokohama, Japan
Trifecta是全球领先的临床技术解决方案提供商,每年出品逾
350场现场直播、自选点播和网络研究员会议,覆盖91个国
家。Trifecta的前瞻性创新培训和门户网站解决方案可提高临床
试验质量,加快研究启动和试验地点的准备工作,优化工作流
程,促进试验地点、赞助方和合同研究机构之间的沟通。
Trifecta的解决方案可轻松融入现有流程,减少对机构的干扰,
成效立竿见影。Trifecta服务世界各地不同规模的项目,实现创
新,落实执行,走向全球。
办事处:洛杉矶 - 印第安纳波利斯 - 费城 - 英国剑桥 - 捷克共和
国布拉格 - 日本横滨
Address: 1120 South Robertson Boulevard, Second Floor, Los
Angeles, CA 90035 USA
Phone: +1-310-385-8642
Email: [email protected]
Website: http://www.TrifectaClinical.com/
Uppsala Monitoring Centre
Company Introduction
Booth#A09
Inspire. Engage. Transform.
Uppsala Monitoring Centre (UMC) advances the science of
pharmacovigilance and inspires patient safety initiatives all over
the world. As an independent, non-profit foundation, we engage
stakeholders who share our vision and collaborate to build a
global patient safety culture. As a leader in the research and
development of new scientific methods, we explore the benefits
and risks of medicines to help minimise harm to patients, and
offer products and services used by health authorities and lifescience companies worldwide. Our unique expertise makes us
an organisation with the capacity to transform patient safety
from an ambition into a reality. For almost 40 years, we have
provided scientific leadership and operational support to the
WHO Programme for International Drug Monitoring, expanding
the global pharmacovigilance network to reach more than 95%
of the world’s population.
Veeva Systems, Software (Shanghai) Co., Ltd
维我软件(上海)有限公司
Company Introduction
Booth#E02, E03
Veeva Systems is a leader in cloud-based software for the
global life sciences industry. Committed to innovation, product
excellence, and customer success, Veeva has more than 375
customers, ranging from the world’s largest pharmaceutical
companies to emerging biotechs. Veeva is headquartered in the
San Francisco Bay Area, with offices in Europe, Asia, and Latin
America. For more information, visit www.veeva.com
Veeva
Systems是全球领先的生命科学行业基于云计算模式
的商业解决方案提供商。致力于提供创新的技术架构,卓越的
产品服务,以及遵循让客户成功的服务理念。目前,Veeva在
全球范围内拥有超过375家企业客户,这些客户中有全球最大
的制药公司,也有新兴的生物技术公司。Veeva总部设在美国
旧金山湾区,并在欧洲、亚洲和拉丁美洲设有办事处。更多信
息,请访问:www.veeva.com/cn。
Company address: Suite 1707-1708, 17F United Plaza, 1468
Nanjing Rd West, Jingan District, Shanghai 200040 China
Contact person: Benson Hao
Phone: +86 21 5108 7366 ext. 831
Fax: +86 21 51087366 ext. 821
E-mail: [email protected]
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
参展商介绍
121
EXHIBITOR DIRECTORY
World Courier (Shanghai) Co., LTD.
世递国际货物运输代理(上海)有限公司
Company Introduction
Booth#E04
Company Introduction
世界速递创办于1969年,总部位于美国康涅狄格州斯坦福,是
全球规模最大和最具经验的专业快递服务商,目前拥有一个由
150多个通过ISO9001认证的全资分支机构组成,活跃于全球
50多个国家的庞大的国际性网络。公司还拥有并经营着全球最
大的符合GMP规范的一体化试验药物存储设施网络,该网络分
布于13个发展中和具有战略意义的地区。通过其全网络范围内
所拥有完全的GxP合规的运输和供应链系统,世界速递满足了
特管行业和其他行业在高时效性和温度敏感性货物运输方面最
严苛的行业和监管要求。
公司地址:上海市浦东区浦东南路1271-1289华融大厦1604,
邮编:200122
联系人:陆女士,张先生
电话:+86 21 5054 0599
电子邮箱:[email protected]
WuXi AppTec Medkey
药明康德 津石医药
Company Introduction
WuXi Clinical Development Services (Shanghai)
Co., Ltd.
上海康德弘翼医学临床研究有限公司
Booth #B01, B02
康德弘翼
康德弘翼(WuXiCDS) ,前身为康德保瑞(WuXiPRA),一家
药明康德(WuXi AppTec)与美国PRA于2012年在中国的合资临
床CRO公司,于2016年重组后更名为康德弘翼,成为药明康德
(WuXi AppTec)集团的全资子公司。我们为药品、生物制品和
医疗器械/诊断试剂等医药产品的开发提供全方位的I至IV期及上
市后一站式临床研究服务。
WuXi CDS
WuXi CDS, previous named as WuXiPRA, a joint venture China
CRO established in 2012 by WuXi AppTec and PRA Health
Sciences, now restructuring completed and renamed as WuXi
CDS in 2016 become a wholly-owned subsidiaries of WuXi
AppTec. We offer one-stop full service for comprehensive Phase
I – IV clinical trial services for pharmaceuticals, biologics, and
medical devices.
We’re from WuXi Apptec
Established in December 2000, WuXi AppTec is a leading global
pharmaceutical, biopharmaceutical, and medical device openaccess capability and technology platform with operations
in China and the United States. As an innovation-driven and
customer-focused company, WuXi AppTec provides a broad
and integrated portfolio of services throughout the drug R&D
process. Now we have over 10,000 employees and 6.5 million
square feet of laboratory and manufacturing space.
Booth#G02
津石SMO成立于2009年,是全球领先的CRO药明康德新药研
究有限公司的全资子公司,专业从事SMO服务业务,是中国最
大、项目执行经验最丰富的SMO之一。
• 津石在全国50个城市有400多位经验丰富训练有素的CRC
• 操作过20多个领域的200多项临床研究,涉及肿瘤、内分
泌、呼吸、心血管、妇科、风湿和神经精神系统等领域,和
全国300多家医院有深度合作
• 全球排名前20位的跨国药企有15家将津石选择为其优选合作
SMO
• 公司关爱员工,福利待遇良好,培训体系完善,团队非常稳
定,年离职率在10%左右,远低于行业30%的水平
津石SMO还与很多医院建立了深度合作成为优选供应商,并积
极参与行业活动推动行业发展,是“药物临床试验机构联盟”
成员,“DIA中国SMO协作组”成员。在2015年我们的满意度
高达96%。
Besides pre-clinical service, WuXi AppTec has also successfully
established a fully integrated clinical trials services, including
clinical trials management CRO (WuXi CDS), study site
management (SMO/MedKey) , central lab, bio-analytical
services(PK/PD analysis), pathology lab (cell based and tissue
based biomarker, IHC, FISH, DISH, FACS/Flow cytometry) and
genomic services (PCR, Sanger Sequencing, NGS).
迎接法规变革,聚力专业质量
2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
122
参展商介绍
EXHIBITOR DIRECTORY
Zigzag Associates Ltd
Company Introduction
Zuellig Pharma Specialty Solutions Group
裕利医药特别解决方案部
Booth #J03
About Zigzag
Our experienced global team provides a full range of Quality
Assurance (QA) services. With a completely flexible approach,
we provide you with the right resource, wherever and whenever
you need it.
Our Services
We offer a full range of QA services within GCP, GVP, GMP, GLP,
CSV, GDP and PV. A snapshot of these services includes:
• Auditing, including management of audit programmes
• Gap analysis
• Consulting on risk management audit platforms
• Corrective action and preventative action management
• Inspection readiness and post-inspection support
• Quality management system development
• Standard operating procedure writing and review
• Training
• Establishing PV systems for drug development and marketed
product
• In house support
• General consultancy
Global Reach – Local Response
We have worked in over 70 countries with offices in the UK,
Singapore and USA. Our experience and understanding of
local practices is second to none and our Queen’s award for
international trade is testament to our continued ability to deliver
a consistent service to our clients across the globe.
Whether you require a single audit or a team to manage a global
programme, we have the resources and the expertise to deliver.
In addition to our global team we have offices in the following
locations:
UK
-Singapore-USA
Company Introduction
Booth #J07
Zuellig Pharma Specialty Solutions Group (SSG) is a regional
consulting and bio-logistics service company and a member
of the Zuellig Pharma Group. SSG leverages Zuellig Pharma’s
cutting edge pan Asian distribution infrastructure to provide
value added bio-logistics solutions for pharmaceutical and
clinical trial companies.
SSG specializes in clinical trial logistics services, offering
consultancy, storage and distribution services for IP, Comparators
and Ancillaries through its unrivalled and proprietary network of
15 central and local depots.
We garnered experience from over 1,000 Clinical Trials conducted
in controlled ambient, cold chain and ultra-low temperature.
The hallmark, a wide range of value added services that include
exportation-& importation, labeling, returns & destruction and
comparator drug sourcing, differentiates us from the ordinary.
Our China team is looking forward to meet you during the DIA
exhibition and introduce our services.
裕利医药特别解决方案部(裕利SSG)是裕利医药集团旗下的
生物药品及临床试验药品运输配送服务性子公司。 目前在14个
国家及地区拥有15个中央和各国家地区的临床药品仓储配送中
心。
裕利SSG主要与药厂和临床试验研究公司合作,提供临床试验
药品仓储运输配送, 并协助临床项目采购原研药/对照药及其它
临床项目的辅助医疗器材和配件。服务配送范围覆盖试验室到
各临床研究中心或医院,
提供点到点全面供应链运输配送服
务。
目前为止,裕利SSG服务超过1000多个临床一期, 二期,三
期到四期的试验项目。包括药品温控物流;冷冻链仓储物流;
干冰及超低温(如负196度)临床药品仓储和配送;以及其它
相关的增值服务:原研药/对照药采购;二次包装;药品进出口
及临床废料品回收和销毁。
裕利期待与您在DIA会展上面对面的交流!
Company address: 15 Changi North Way #01-01 Singapore
498770
Contact person: Ms. Rong Chen
Phone: +86 10 6535 0305 (Beijing Office)
E-mail: [email protected]
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
会议支持方
PARTNER ACKNOWLEDGEMENTS
DIAMOND LEVEL SUPPORTER
REFRESHMENT BREAK SUPPORT
Quintiles
E&Y CRO
PLATINUM LEVEL SUPPORTER
WuXi CDS
WHITE PAPER SHOWCASE
MobileMD System
太美医疗系统
MobileMD System
Medidata
GOLD LEVEL SUPPORTER I - WELCOME RECEPTION
Hangzhou Tigermed Consulting Co., Ltd.
Certara L.P.
INTERNET BOOTH & RECHARGING STATION
Merge, an IBM Company
Novotech
FLYER INSERT IN ATTENDEE BAG
Zuellig Pharma Specialty Solutions Group
ATTENDEE BAGS
CLINIPACE
Merge, an IBM Company
Covance
ArisGlobal
STAMP RALLY CARD
Catalent
LANYARDS
Kun Tuo
Cenduit LLC
123
迎接法规变革,聚力专业质量
2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
124
会议支持方
PARTNER ACKNOWLEDGEMENTS
BOTTLED MINERAL WATER
LUNCH TISSUE
Cenduit LLC
Jiaxing Clinflash Computer Technology Co. Ltd
Teddy Clinical Research Laboratory (Shanghai) Limited
EMAIL PROMOTION
Springer Nature
The 2nd Advanced Workshop on
Medical Affairs,
Medical Communications, and
Medical Science Liaison
December | Shanghai
第二期医学事务/医学沟通/医学联络
高级研讨班
12月 | 上海
Contact: Kathy Yuan
Tel.: +86 21 60577239 Email: [email protected]
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
125
源自北欧的数据艺术
The art of data management originated in Northern Europe
致力于生命科学的IT服务
IT Services Dedicated to
Life Sciences
NNIT是全球生命科学行业IT开发、实施、验证和
运营方面的一流咨询公司。我们起源于生命科学行
业,有超过20年的从业经验,提供涵盖整个医药价
值链的综合IT咨询服务与解决方案。凭借深厚的底
蕴与经验,我们能深入理解医药流程、IT解决方案
以及法规要求。由此,我们能够提供符合GxP等法
规要求的解决方案,无论是咨询、应用或者外包服
务。
NNIT is an international consultancy in the development, implementation, validation and operation of IT for the life sciences industry. We
are born out of the life sciences industry and have more than 20 years
of experience delivering integrated IT solutions covering the pharmaceutical value chain. Our strong heritage and experience give us a
unique understanding of pharma processes, IT solutions and regulatory demands. Which is why we can deliver the right GxP compliant
solution, no matter if it is within consulting, applications or hosting.
NNIT分公司遍布欧洲、美国及亚洲。NNIT中国有
700多名员工,服务不但涵盖中国市场,也是NNIT
全球重要的交付中心。
We operate in Europe, US and Asia. Our office in China has more than
700 employees. NNIT China delivers services within a large range of
technologies to the local market and forms an important part of
NNIT’s deliveries to our European clients.
欢迎您莅临F09和F10展位与我们的专家共同讨论
EDC、CTMS、PV系统以及SAP等解决方案。
You are welcome to meet with us at our booth at F09 and F10 for
an informal discussion with our experts, e.g. about EDC, CTMS, PV
system and SAP services.
NNIT 中国 天津南京路358号今晚大厦A座20层 邮编:300100 电话:+86(22)5885 6666
NNIT A/S Østmarken 3A DK-2860 Søborg Tel: +45 7024 4242
NNIT Switzerland Bändliweg 20 CH-8048 Zurich Tel: +41 44 405 9090
NNIT Germany c/o Regus Herriotstrasse 1 DE-60528 Frankfurt am Main
NNIT Czech Republic Explora Jupiter Bucharova 2641/14 2.NP CZ-158 00 Prague 5 Tel:+420277020401
NNIT USA 650 College Road East Princeton, New Jersey 08540 Tel: +1 (609) 955 4949
NNIT Philippines 24/F 88 Corporate Center 141 Valero St. PH-Makati City 1227 Tel: +63 2 889 0999
NNIT United Kingdom c/o MoFo Notices Limited CityPoint One Ropemaker Street London
126
迎接法规变革,聚力专业质量
2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
公司
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
127
上海日新医药发展有限公司
EPS International (China) Co., Ltd. 上海日新医药发展有限公司
上海日新医药发展有限公司是提供全领域的临床试验专业服务的合同研究组织(CRO)。我们有超过 100 个专业雇员,主要专业
背景有临床医学、药学、临床药理和生物统计学,并且均接受过 GCP 和临床研究的良好培训,与欧美、日本制药公司有良好
的沟通能力。凭借总部 EPS 集团在日本从事 CRO 业务二十多年的经验和集团在日本、美国、中国大陆、中国台湾、新加坡等
国家和地区的分公司和代表处的雄厚实力,迄今为止,上海日新已经为客户成功交付超过 130 个临床方案和研究,试验期从 I
期到 IV 期,涉及肿瘤、心血管、脑和神经、免疫和过敏、眼科和抗感染等方面的领域。更多信息欢迎访问网站 www.epsgr.com
及咨询 [email protected]
EPSICN carried out full clinical research service for global clients as a CRO, our offices in China have more than 100 professional
employees with academic background mainly in clinical medicine, pharmacy, clinical pharmacology and biostatistics, who had
received GCP and clinical studies of good training. With EPS Group’s strong presence in Asia and worldwide like Japan, USA,
mainland China, Taiwan, Singapore, etc for more than 20 years of experience in CRO industry, so far, we have successfully
delivered over 130 clinical programs and research in China, ranged from Phase I-III clinical trial, regulatory to phase IV
post-marketing services. EPSICN has the capacity to conduct any clinical trial in all major therapeutic areas, from a single local
study to programs spanning multiple continents. For more information, please visit www.epsgr.com and enquire
[email protected]
Improve your
probability
of success
Superior
delivery
™
Better
outcomes
Creating a healthier world demands a new way of
working together. A broader understanding of medicines
and markets. Data visibility to refine strategy and
prove value. With an integrated view of the healthcare
continuum, Quintiles is building biopharma and life
sciences solutions — from pipeline to portfolio to
population health™.
How can we help you?
Contact us:
China: 4008810237
www.quintiles.com/china
[email protected]
Copyright © 2016 Quintiles 08.0024-2-04.16
Connecting
insights
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
eStart Medical Technology Co.,Ltd.
易启医药科技有限公司
易启医药科技有限公司(简称:易启医药) 是国内唯一一家以早期临床试验为主要服务
的合同研究组织(CRO)。特别是仿制药一致性评价、生物等效试验、创新药物首次人体试和
早期临床试验、心脏毒性临床评价 (IQT 和 TQT 试验)等全产业链服务, 包括项目注册和战略
咨询、项目管理和监查、项目稽查、方案设计、数据管理、生物统计、临床电子数据采集(EDC)、
新药 I-IV 期临床试验;近几年,公司核心团队近几年完成了近百项各期临床试验, 其中 50
多项创新药物 I 期临床试验和生物等效性试验,并且通过了几十家国内外制药企业各种项目
稽查和监查、药监部门的核查和视察。
2010 年曾参与《药物Ⅰ期临床试验管理指
导原则》和《药物临床试验生物样本分析
实验室管理规定》撰写(2011 年已经颁布);
2013 年:完成的《依马替尼生物等效性试
验》通过 CFDA 认证核查中心全国首个生
物等效性试验新标准的专项检查;
2013 年:完成全国首个符合国际标准(E14)
的心脏毒性 TQT 试验。
易启医药与北京、天津、长春等多家临床试
验机构和 I 期临床试验病房建立了紧密合作的伙
伴关系,通过强强联合使 I 期临床试验项目进行
的严谨顺畅,深得国内外药企信任和好评。特别
是在早期临床试验项目管理和质量方面赢得国内
外诸多制药企业和国家药物监管部门的认可。
地址:北京市海淀区首体南路 20 号
电话:010-88354800
CMO:侯杰
18611422958
[email protected]
VP:李劲彤
15300059186
[email protected]
129
130
迎接法规变革,聚力专业质量
2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
CPhI China 2016
第十六届世界制药原料中国展
2016.6.21-23
上海新国际博览中心(SNIEC)
同期举办:
第十一届世界制药机械、包装设备与材料中国展
160,000m2 展示规模
2,800+ 参展企业
80+ 现场会议解析行业趋势
65,000+ 专业观众
特别主题活动:
中国 - 中东欧年系列活动
- 第二届中国—中东欧国家卫生部长论坛健康产业合作分论坛
暨第七届中国与世界医药企业家高峰会
- 医药国际化百强企业评选
- 中国 - 中东欧企业洽谈专区或对接会
“研发日”特别活动:
CPhI China 主办方将为生物医药研发领域的观众量身定制
2 大“研发专项参观路线”
,推荐重点关联展区、主题会议、
技术转移专场及特别活动等,通过针对性的参观路线设计及时
间规划,优化生物制药研发、生产及技术领域人员的参观体验。
更多高端会议及活动
- CPhI 国际药政答疑会
- GEP 认证培训及 FDA 对膳食补充剂原料要求
- CPhI, ICSE & PMEC 中国展创新与发展论坛
- 米内论道
- CPhI 制剂企业交流沙龙
记
预登
扫
门票
扫一
士尼
迪
赢取
机会
有
就
- 药用辅料分销及供应链安全研讨会
- 第三届中国生物制药峰会
更多详情,敬请关注 www.cphi-china.cn
010-58036315 / 021-33392252
131
YZ,RUUX
Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
141
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迎接法规变革,聚力专业质量
2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
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Quality & Transformation - New Era of Drug Development
The 8th DIA China Annual Meeting | May 15-18, 2016 | China National Convention Center, Beijing
会场平面图
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͑
迎接法规变革,聚力专业质量
2016中国国际药物信息大会暨第八届DIA中国年会 • 5月15-18日 • 北京国家会议中心
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Call for Papers
THERAPEUTIC
INNOVATION
& REGULATORY
SCIENCE
O FFI C IA L J O U R N A L O F D IA
VO LU M E 4 9 • N U M B ER 1 • JA N UA RY 2 01 5
2015 and Beyond
Stephen P. Spielberg, Editor-in-Chief
Patient Engagement by Pharma—Why and How?
A Framework for Compliant Patient Engagement
A Universal Framework for the Benefit-Risk Assessment
of Medicines: Is This the Way Forward?
Clinical Development Approaches and Statistical Methodologies
to Prospectively Assess the Cardiovascular Risk
of New Antidiabetic Therapies for Type 2 Diabetes
Methods and Issues to Consider for Detection of Safety Signals
From Spontaneous Reporting Databases: A Report of the
DIA Bayesian Safety Signal Detection Working Group
Incorporating Historical Data in Bayesian Phase I Trial Design:
The Caucasian-to-Asian Toxicity Tolerability Problem
How Should a Globalized CTD Be Created?
An Introduction to the Japanese 3-Layer Approach
tirs.sagepub.com
ISSN: 2168-4790
Therapeutic Innovation &
Regulatory Science
Editor-in-Chief
Stephen P. Spielberg, M.D., Ph.D.
Therapeutic Innovation & Regulatory
Science (TIRS) is the official scientific
journal of DIA that strives to advance
medical product discovery, development,
regulation, and use through the publication
of peer-reviewed original and review
articles, commentaries, and letters to the
editor across the spectrum of converting
biomedical science into practical solutions
to advance human health.
Visit us at: tirs.sagepub.com
The focus areas of the journal are as follows:
• Biostatistics
• Clinical Trials
• Product Development
and Innovation
• Global Perspectives
• Policy
• Regulatory Science
• Product Safety
• Special Populations
When you publish in Therapeutic Innovation & Regulatory Science, you will benefit from:
• Rigorous peer review of your research
• Increased visibility, readership and impact of author’s works
• New avenues for discovery in digital environment
• High visibility for maximum global exposure
Submit your manuscripts online at
http://mc.manuscriptcentral.com/tirs
Average time from submission to first decision is under 30 days!
DIA
2017
中国国际药物信息大会
暨第九届DIA中国年会
5月21-24日 | 上海国际会议中心
The 9th DIA China Annual Meeting
May 21-24 | Shanghai International Convention Center, China
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