8th Latin American Congress on Clinical Research Latin

8th Latin American Congress on
Clinical Research
Latin America Role in
Worldwide Clinical Research
Pre-congress
courses:
October
19,18,
2011
April 19-21, 2010
Tutorials:
April
2010
Congress:
October
20-21,
2011
Marriott Bethesda North Hotel & Conference Center, Bethesda, MD, USA
Panamericano Hotel & Resort, Buenos Aires, Argentina
CONGRESS CHAIRPERSON
Juan Carlos Groppa, MD
Past President, SAMEFA (Argentine Society of
Pharmaceutical Medicine)
Medical Affairs Manager. Laboratorios Bágo S.A., Argentina
SCIENTIFIC COMMITTEE CHAIRPERSON
Hugo Cohen Sabban, MD
President, SAMEFA (Argentine Society of
Pharmaceutical Medicine)
CEO, CRO BIOSOLUTION, Argentina
This three-day congress will include two pre-congress courses and a
two-day conference focusing on both the global and regional aspects
of clinical research.
FEATURED TOPICS
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SCIENTIFIC COMMITTEE
Sebastián Batagelj, MD
Medical Advisor, Laboratorios Bagó, Argentina
Daniel Ciriano, MD
Medical Director - Roche Argentina
Andrea Costantini, MD
Medical Advisor, Phoenix Laboratories, Argentina
Luis Collia, MD
Medical Director, Laboratorios Craveri, Argentina
Wanda Dobrzanski, MD
Medical Director, Medical & Scientific Affairs, Respiratory and
Infectious Diseases, i3 Global, Argentina
Rosana Felice, MD
Medical Director, Argentina & Southern Cone, GlaxoSmithKline,
Argentina
Gustavo Fischbein, MD
Medical Director, Osmotica Pharmaceutical, Argentina
Pablo Hammerschmidt, MD
Regional Director, Clinical Operations, ICON Clinical Research,
Argentina
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Cell-Based Therapies: The New Drug Class
Latin America Regulatory Affairs Update
First Time in Man & Early Phase Trials
The Contribution of Latin America to Data Quality on Marketing
Applications
Clinical Safety and Pharmacovigilance
Ethical Issues: A Permanent Dilemma
Endpoints, Surrogates and The Rationale on Study Design
Streamlining Logistics in the Region
Sponsoring of Clinical Research by Nontraditional Players
Biosimilars and the road ahead
PRECONGRESS COURSES
October 19th
# 1 Risk Project Management
# 2 Clinical Quality Assurance: The Basics
Gabriela Kivelevitch, MD
WHO SHOULD ATTEND
Sandra Mercurio, MD
Professionals involved directly and/or indirectly in clinical research, or who
are considering initiating their activities in this professional area, including:
Luis Pliego, MD
• Research professionals (clinical,
• laboratory, site members, and
CRAs)
• CROs and SMOs
• Service providers
Medical Advisor, Laboratorios Phoenix, Argentina
Medical Director & Lead Nominated Signatory, AstraZeneca ,
Argentina
Regional Medical & Regulatory Affairs Manager, Janssen-Cilag,
Argentina
Luis Ramirez, MD
Regional Head Clinical Operations for Latin America,
Boehringer-Ingelheim, Argentina
Rosa Scuteri, MD
Medical Advisor, Laboratorio Raffo , Argentina
Daniel Vazquez, MD
Senior Director and Latin America Head, Global Regulatory
Affairs, Quintiles Argentina S.A., Argentina
Marcelo Vianna de Lima
Medical Director, Latin America , Medical Diagnostics,
GE Healthcare, Brazil
Silvia Zieher, MD
• Clinical investigators
(active and potential)
• Ethics committees
• Regulatory agencies
• Medical education institutions
• Pharmaceutical sponsors
Simultaneous Translation will be available in Portuguese, English,
and Spanish
Executive Director, Latin America Operations, INC Research,
Argentina
All registrations will be processed by Samara & Enrique (Meeting Planners)
Contact Information for Registration and Tabletop Opportunities
Roxana Samara, Exhibits Department
+54 9 11 5664 0160 / +54 11 4774 7531
Email address: [email protected]
Registration Link: www.samara-enrique.com.ar/dialatam2011
DIA Program Contact Information
Constance Burnett, Program Developer
+1 215.293.5800 (tel) | email:[email protected]
Worldwide Headquarters
Drug Information Association, Inc.
800 Enterprise Road, Suite 200
Horsham, PA 19044, USA
Regional Offices
Basel, Switzerland
Tokyo, Japan
Mumbai, India Beijing, China
Co-sponsored by
2
DAY 1 | WEDNESDAY, OCTOBER 19TH
08:00-08.45 REGISTRATIONS
09:00–06.30
PRE-CONGRESS TUTORIALS
Tutorial 1: Risk Project Management
08:30-10:00 Conference: Adult Mesenchymal Stem Cells are the New
Medicine for Diseases
Session Chairperson
María Jimena Fernández Bartolomé
Monitora Estudios Clinicos, Roche, Argentina
Course Director
Speaker
Mr. Marty Hynes III
Arnold Caplan
Six Sigma Champion, Senior Director Product R&D, Lilly Research
Laboratories, Ely Lilly and Company
Tutorial 2: Clinical Quality Assurance, the Basics
Course Directors
Ezequiel Klimovsky
Associate Director, QUID -Quality in Drugs and Devices- LATAM
Consulting SRL, Argentina
Margarita Eiletz
Managing Director, Ethics & Excellence SRL, Argentina
DAY 2 | THURSDAY, OCTOBER 20TH
07:00-08.00 REGISTRATIONS
08:00-08:30
OPENING
Welcome and Introduction to DIA 2011
Session Chairpersons
Juan Carlos Groppa (SAMEFA)
Argentine Society of Pharmaceutical Medicine
Medical Affairs. Laboratorios Bágo S.A., Argentina
Yves Julliet (DIA)
DIA President, USA
PLENARY SESSION
Director, Skeletal Research Center, Professor of Biology and
General Medicine Sciences, Case Western Reserve University,
Cleveland Ohio, USA
10:00–10:30 REFRESHMENT BREAK
10:30-12:30 PLENARY SESSION
Round Table: Medical Devices – Clinical Trials
Session Chairperson
Marcelo Vianna de Lima
Medical Director, Latin America - Medical Diagnostics, GE
Healthcare, Brazil
Session Co-Chairperson
Hugo Cohen Sabban
President, SAMEFA (Argentine Society of Pharmaceutical Medicine)
CEO, CRO BIOSOLUTION, Argentina
Local Requirements to Running Studies with Devices
Marta Kaufman
ANMAT (Administración Nacional de Medicamentos, Alimentos
y Tecnología Médica), Argentina
Experiences from FDA Inspections on Clinical Trials with Devices in the
Latin American Region
Matthew J. Tarosky
Acting Director, Division of Biosresearch Monitoring Office
of Compliance, Center for Devices and Radiological Health
(CDRH), FDA
Captain, U.S. Public Health Service
I Have a Device, and Now?
Hugo Kuprinsky
Specialist in Obstetrics, CEMIC, Argentina
12:30–02:00
LUNCHEON
02:00-04:00 CONCURRENT SESSIONS
Round Table: Biosimilars in Latin America
Session Chairperson
Joao Masssud
Trials Consulting, BRASIL
Session Co-Chairperson
Daniel Mazzolenis
General Manager, Kendle , Argentina
Studies with Biologicals in Latam
Julio Camps
Regional Director, Latin America, Amgen Development
Operations, USA
Studies with Biosimilars in LatAm
Speaker to be confirmed
B&B Development Dilemmas for Latin American Companies
Roberto Diez
Clinical Research Manager, Bio Sidus S.A., ARGENTINA
04:00–04:30 REFRESHMENT BREAK
Round Table: The contribution of Latin America Data
to Marketing Applications: a Focus on Quality
Session Chairperson
Silvia Zieher
Executive Director, Latin America Operations, INC Research,
Argentina
Ethical and GCP Standards in Latin America: a General Overview
of the Research Ethics Committees and Regulatory Framework
Anna Paula Más
Associate Director, Global Regulatory Development, Latin
America, Global Regulatory Affairs, Brasil
An Overview of FDA Inspections Experience in Latin America.
FDA Interactions with Local Regulatory Agencies
Paul Seligman
Director, FDA Latin America Office
Latin America Regional Office, Costa Rica
EMA Inspections Experience in Latin America and Impact of the
Reflection Paper 2010
Fergus Sweeney, EMA (via teleconference)
Head of Sector Compliance and Inspections
EMA (European Medicines Agency), United Kingdom
3
04:30-06:30 CONCURRENT SESSIONS
Round Table: Issues in Logistics within the Region
Session Chairperson
Cecilia Dantuono
Site Manager, Bristol Myers Squibb, Argentina
Session Co-Chairperson
Daniel Vazquez
Senior Director and Latin America Head, Global Regulatory
Affairs, Quintiles Argentina S.A, Argentina
Local Requirements
Marina Ordoñez
Clinical Site Manager, Bristol Myers Squibb, Perú
Topic to be Confirmed
Antonela Mangiaterra
Associate Manager, Clinical Logistics, PAREXEL International
Clinical Logistics Services | Latin America, Argentina
Topic to be Confirmed
Flavio Echemendigaray
Warehouse Manager, Genzyme, Argentina
Round Table: Understanding the Rationale behind
the Design of Clinical Research: What Endpoints and
Surrogates Intend to Demonstrate
Session Chairperson
Gustavo Fischbein
Medical Director, Osmotica Pharmaceutical Argentina
Session Co-Chairperson
Marlene Llópiz Avilés
CEO - CRO Mexicana, S.C. CEO - CRO Mexicana, S.C. Mexico
Objectives in Cardiovascular Research
Daniel R. Nul
Medical Director, Clínica Constituyentes, Argentina
Objectives in Oncology Research
Speaker to be confirmed
Objectives in CNS Research
Gonzalo Gómez Arévalo
Director, Phvlatam, Argentina
DAY 3 | FRIDAY, OCTOBER 21ST
10:00–10:30 REFRESHMENT BREAK
07:00-08.00 REGISTRATIONS
10:30-12:30 PLENARY SESSION
08:00–08:30 IFAPP CONFERENCE
Round Table: Latin American Regulatory Affairs Update
Session Chairperson
Session Chairperson
Medical Director, Laboratorios Craveri, Argentina
Session Co-Chairperson
Luis Collia
Speaker to be confirmed
Speaker
Daniel Vazquez
Norbert Clemens
Head Clinical Development, CRS Clinical Research Services
Mannheim GmbH, Germany
08:30-10:00
PLENARY SESSION
Conference: Early Phase Trials
Session Chairperson
Leylen Colmegna
CEO, LAT Research, Argentina
Introduction to Early Phase Trials
Leylen Colmegna
CEO, LAT Research, Argentina
What is Needed to Conduct Early Phase Trials in Humans
Speaker to be confirmed
Today´s Latin American Experience in Early Phase Trials
Speaker to be confirmed
01:00–02:00 LUNCHEON
02:00-04:00 CONCURRENT SESSIONS
Round Table: Sponsoring Clinical Research by Non
Traditional Players
Session Chairperson
Mario Boskis
Chairman and CEO, ActivaCro, Argentina
Co-Session Chairperson
Fernando Martinez
Executive Director Global Operations, inVentiv Clinical Solutions
LLC, Madrid, Spain
Public and Private Consortiums in Latin America for the
Development of Innovative Products
Hugo Sigman
CEO, Chemo Group, Argentina
Innovations in Latin America. Fiction or Reality?:
An Inventor´s Perspective
Juan Carlos Parodi
Consultant, Vascular Surgery Department , FLENI, Argentina
Neglected Diseases: From Discovery to Availability to Patients.
A New Paradigm in R&D
Isabela Ribeiro
Head of Chagas Clinical Program, Drugs for Neglected
Diseases Initiative (NDDI), Sao Paulo, Brazil
Senior Director and Latin America Head, Global Regulatory Affairs,
Quintiles Argentina S.A., Argentina
Update on Current Clinical Research Regulations Status in Different
Latin American Countries
Flavia Regina Souza Sobral
Specialist in Regulation and Sanitary Surveillance, Anvisa
National Agency of Sanitary Surveillance, Brasil
Representatives from Argentina, Chile, Mexico and Perú
12:30-01:00 PLENARY SESSION
Conference: Pediatric Drug Development.
An FDA Perspective
Speaker
Benjamín Ortiz
Medical Officer, International Team
Office of Pediatric Therapeutics, Office of the Commissioner,
US Food and Drug Administration
Round Table: Clinical Safety and Pharmacovigilance
Session Chairperson
Gerardo Méndez Ciancaglini
Product Information & Consumer Service Department Head,
Laboratorios Bagó S.A., Argentina
PV outlook: National and International Companies Perspective
Are Both Looking for the Same?
Speaker to be confirmed
Current Standards
Mariano Madurga
Head of Pharmacoepidemiology and Pharmacovigilance
Area, Pharmacoepidemiology and Pharmacovigilance
Division, Medicines of Human Use Department , Spain
CDER Current Experience
George Rochester
Associate Office Director for Safety Assessment,
Office of Biostatistics CDER, FDA
4
04:00–04:30 REFRESHMENT BREAK
04:30-06:30 CONCURRENT SESSIONS
Round Table: Ethical issues: A Permanent Dilemma
Session Chairperson
Round Table: Latin America - Educational Options in
Clinical Research
Session Chairperson
Sandra Mercurio
Medical Director & Lead Nominated Signatory, AstraZeneca,
Argentina
Session Co-Chairperson
Wanda Dobrzanski Nisiewicz
Medical Director, Medical & Scientific Affairs, Respiratory and
Infectious Diseases, i3 Global, Argentina
Juan Carlos Groppa
Past President, SAMEFA (Argentina Society of
Pharmaceutical Medicine)
Medical Affairs Manager. Laboratorios Bágo S.A., Argentina
Speakers
Speakers and topics to be confirmed
Post Trial Treatment
Patricia Saidón
Specialist in Neurology and Independent Consultant,
Argentina
The New Vulnerable Populations
María López Bresnaham
VP and Global Head, Medical and Scientific Affairs, i3, USA
Transforming Interactions with HCP´s
Regina Kuchle
Legal Director and IP Consultant for LATAM,
ASTRA ZENECA, MEXICO
06:30 CONGRESS ADJOURNED
Unless otherwise disclosed, DIA acknowledges that the statements made by speakers are their own opinion and not necessarily
that of the organization they represent, or that of the Drug Information Association.
Speakers and agenda are subject to change without notice.
Recording of any DIA tutorial/workshop information in any type of media, is prohibited without prior written consent from DIA.
Travel and accommodation in Buenos Aires
The City of Buenos Aires has two airports:
• Ministro Pistarini International Airport in Ezeiza, 45 kms from downtown Buenos Aires, connecting the city with the rest of the world
• Jorge Newbery International Airport, only 15 minutes from downtown Buenos Aires, connecting the city with the rest of the country
and some Latin American destinations.
The city has efficient radio-taxi and car rental services, available the 24 hours. Buses and a broad underground network facilitate the
access to every corner of the city.
Where to stay
Buenos Aires is a city of intense cultural life, with plenty of diverse touristic attractions. All choices of hotels and accommodations are
possible. Take a moment to visit www.buenosaires.com.ar to find out rates of different hotel categories.
Hotel information and reservations for congress attendees
In order to receive discounted room rates at Panamericano Hotel & Resort, reservations MUST be made through the Congress
organizers.
You must be registered for the Congress to reserve your room
Please, contact [email protected] directly to make your hotel reservation or for information on other
conveniently located hotels nearby the congress venue.