Fall15 - Agenda - Generic Pharmaceutical Association

Transcription

Bethesda North Marriott Hotel and Conference Center
North Bethesda, MD
November 2-4, 2015
Fall Technical
Conference
2015
Monday, November 2, 2015
USP Workshop (separate registration required)
7:00 a.m. - 8:20 a.m.
Pre-Conference USP Workshop Registration
8:30 a.m. – 8:40 a.m.
Welcome and Intro
Emily Kaine, M.D.
Vice President, Strategy and Business Development, U.S. Pharmacopeial Convention
8:40 a.m. - 9:15 a.m.
USP Transition to the 2015-2020 Cycle
Mario P. Sindaco, M.S., M.B.A.
Director, Compendial Affairs and Executive Secretariat, Council of Experts
U.S. Pharmacopeial Convention
o CoE and ECs
o Resolutions overview
o Stakeholder resources
o Recent and upcoming general stakeholder interactions
o Pending Monograph program
9:15 a.m. - 9:30 a.m.
USP Science in 2015-2020: Elemental Impurities Implementation Update
Mario P. Sindaco, M.S., M.B.A.
Director, Compendial Affairs and Executive Secretariat, Council of Experts
U.S. Pharmacopeial Convention
9:30 a.m. - 10:00 a.m.
Reference Standards Evaluation Overview
Steve Rau
Manager, Reference Standards Evaluation, U.S. Pharmacopeial Convention
10:00 a.m. - 10:15 a.m.
Networking Refreshment Break
10:15 a.m. - 10:40 a.m.
USP-NF Up-to-Date Overview and Stakeholder Involvement
Leonel M. Santos, Ph.D.
Director, Chemical Medicines, U.S. Pharmacopeial Convention
10:40 a.m. - 11:05 a.m.
USP Strategy: USP-NF Excipient Specifications Up-to-Date by 2020
Catherine M. Sheehan, M.S.
Senior Director, Excipients & PDG, U.S. Pharmacopeial Convention
11:05 a.m. - 11:30 a.m.
Current Approaches to Standards for Biologics and Biosimilars
Tina S. Morris, Ph.D.
Global Leader, Biological Standards, U.S. Pharmacopeial Convention
11:30 a.m.
USP Workshop Concludes
Monday, November 2, 2015
2015 GPhA Fall Technical Conference - Day 1
7:00 a.m. – 5:00 p.m.
2015 Fall Technical Conference Registration - Grand Ballroom Foyer
11:30 a.m. – 1:00 p.m.
Networking Welcome Lunch - Lower Level
1:00 p.m. – 1:15 p.m.
Welcome and Introduction
David Gaugh, R.Ph.
Senior Vice President, Sciences & Regulatory Affairs, GPhA
1:15 p.m. – 2:00 p.m.
Office of Generic Drugs Update
Kathleen Uhl, M.D.
Director, Office of Generic Drugs, CDER, FDA
2:00 p.m. – 2:45 p.m.
Office of Pharmaceutical Quality Update
Lawrence Yu, Ph.D.
Deputy Director, Office of Pharmaceutical Quality, CDER, FDA
2:45 p.m. – 3:30 p.m.
Networking Refreshment Break - Grand Ballroom Foyer
3:30 p.m. – 4:30 p.m.
DSCSA: Beyond Implementation
Moderator: Eric Marshall
Senior Director, Leavitt Partners Collaborative Advocates
Mary Anne Anderson
Director, Regulatory Affairs, Sagent Pharmaceuticals
Mark Gutmann
Senior Director Global Serialization Program, Mylan Inc.
Brian Rezach
Partner, OmniMedia Associates LLC
Mary Woods
Executive Director, US Order Management, Allergan
4:30 p.m. – 5:30 p.m.
Biosimilars Council - Key Issues
Bruce Leicher, J.D.
Senior Vice President and General Counsel, Momenta Pharmaceuticals, Inc.
Peter Sullivan, Pharm.D.
Director of Professional Affairs and Medical Information, Amneal Biosciences
5:30 p.m. – 7:00 p.m.
Networking Welcome Reception - Grand Ballroom Foyer
Tuesday, November 3, 2015
7:00 a.m. – 8:30 a.m.
Networking Breakfast - Lower Level
8:30 a.m. – 8:45 a.m.
Welcome and Introduction
David Gaugh, R.Ph.
8:45 a.m. – 9:00 a.m.
State of the Association
Chester “Chip” Davis, Jr.
President and CEO, GPhA
9:00 a.m. – 10:30 a.m.
Pharmacovigilance
Moderator: Gordon Johnston, R.Ph., M.S.
Principal, Gordon Johnston Regulatory Consultants LLC
Joan Janulis, RAC
Vice President and Regulatory Affairs Practice Head, Lachman Consultants Services, Inc.
Mark Vieder, R.Ph., MBA
Director, Safety and Medical Writing, Biorasi
10:30 a.m. – 11:00 a.m.
11:00 a.m. – 12:00 p.m.
OPQs Integrated Quality Assessment
Overview
Susan Rosencrance, Ph.D.
Office Director (Acting), Office of Lifecycle Drug Products, OPQ, CDER, FDA
Benefits and Challenges from the Regulatory Business Process Manager
Hany Edward, Pharm.D., M.S.
Branch Chief (Acting), Regulatory Business Process Management II, Branch III
OPRO, OPQ, CDER, FDA
Benefits and Challenges from the Application Technical Lead
Pahala Simamora, Ph.D.
Branch Chief (Acting), Division of Liquid-based Drug Products, Office of Lifecycle Drug Products
OPQ, CDER, FDA
Additional Panelist:
Robert Iser, M.S.
Office Director (Acting), Office of Process and Facilities, OPQ, CDER, FDA
Ann Marie Montemurro
Supervisory Consumer Safety Officer, Office of Global Regulatory Operations and Policy
ORA, CDER, FDA
12:00 p.m. – 1:15 p.m.
Fall Technical Conference Luncheon - Lower Level
1:15 p.m. –2:30 p.m.
How an ANDA Gets Approved - Steps and Processes
LCDR Kevin Denny, Pharm.D.,
Leader, Division of Project Manager, Office of Regulatory Operations, OGD, CDER, FDA
CDR Craig Kiester, R.Ph., M.S., RAC
Branch Chief (Acting), Branch II, Office of Program and Regulatory Operations, OPQ, CDER, FDA
2:30 p.m. – 3:00 p.m.
ICH – Q12- Industry Perspective
3:00 p.m. - 4:00 p.m. - Salon A-E
Moderator: Keith Webber, Ph.D.
Head of Regulatory Review, Regulatory Affairs
Perrigo Company
Nicholas Cappuccino, Jr., Ph.D.
Vice President and Head of Global Quality
Dr. Reddy’s Laboratories Ltd.
Dawn Culp
Vice President, Global Regulatory Affairs Policy, Mylan Inc.
505 (b)(2)
4:00 p.m. - 5:00 p.m. - Salon A-E
Moderator: Gordon Johnston, R.Ph., M.S.
Principal, Gordon Johnston Regulatory Consultants LLC
David Rosen, J.D.
Partner, Foley & Lardner LLP
Kenneth Phelps
President and CEO, Camargo Pharmaceutical Services
Industry Booths:
• Drug Product Selection - Selection of a Drug Product
and following it thru the R&D process.
• ANDA Review and Approval - How Industry
Manages the ANDA Review and Approvals Process.
Project Manager Exposition (Interactive Session)
3:00 p.m. - 6:00 p.m. - White Oak
Office of Generic Drugs
Drug Product
Selection
Product Launch
Preparation
OPQ RBPMs Who We Are
ANDA Review
and Approval
Entrance
OM’s Division of
User Fee Management
and Budget Formulation
Entrance
GPhA
OPQ RBPMs What’s New in OPQ
• Product Launch Preparation - How Industry Prepares
for an On Time Product Launch.
• GPhA – Learn more about our trade association:
Membership, Regulatory Affairs, State and Federal
Affairs, Biosimilars Council, Meetings, and more.
FDA Booths:
• Office of Generic Drugs
- Organizational Chart
- Roles and Responsibilities (including when to contact)
• Office of Pharmaceutical Quality RBPMs - Who We Are
- Organizational Chart
- Who’s the Point of Contact
- Roles and Responsibilities
• Office of Pharmaceutical Quality RBPMs - What’s New in OPQ
- Highlight New Processes
- Then and Now
- When to Contact OPQ RBPMs
- Highlight the new Learning & Professional Development (LPD) and Organizational Excellence (OE ) branches
• Office of Management’s Division of User Fee Management and Budget Formulation
- When to Contact OM
- How to Contact OM
- Helpful Tips for Industry
- Address Areas of Concerns Related to GDUFA User Fees
Project Manager Exposition
3:00 p.m. - 6:00 p.m. - White Oak
Participants:
CAPT Trellis Adams, MSHS, BSN, WCC, CPHM, Regulatory Business Process Manager, OPRO, OPQ, CDER, FDA
Thushi Amini, Ph.D., Associate Director for Regulatory Affairs (Acting), Office of Research and Standards, OGD, CDER, FDA
Kris Andre, M.S., Senior Regulatory Project Manager, Office of Research and Standards, OGD, CDER, FDA
Thanh Andrews, M.A., BS, Special Assistant, Office of Regulatory Operations, OGD, CDER, FDA
Lloyd Ballou, Division Director, Organizational Excellence and Learning and Professional Development, OPRO, OPQ, CDER, FDA
Surjit Basi, Pharm.D., Regulatory Project Manager, Division of Project Manager, Office of Regulatory Operations, OGD, CDER, FDA
Michael Bohling, Director Marketing, Apotex Corp.
CDR Tessa Brown, DHSc, MPH, BSN, RN, Regulatory Project Manager, Division of Project Manager, Office of Regulatory
Operations, OGD, CDER, FDA
Michael Brzica, Senior Director of Federal Affairs, GPhA
LT Yen Anh Bui, Pharm.D., Team Leader, Division of Project Manager, Office of Regulatory Operations, OGD, CDER, FDA
Tanya Clayton, Division Director (Acting), Acting Branch Chief, Regulatory Business and Process Management Branch I, OPRO, OPQ, CDER, FDA
Tramara Dam, Pharm.D., Regulatory Project Manager, Division of Project Manager, Office of Regulatory Operations, OGD, CDER, FDA
Mary Dempsey, Associate Director for Regulatory Affairs, Immediate Office, OGD, CDER, FDA
LCDR Benjamin Y. Danso, Pharm.D., Branch Chief (Acting), Regulatory Business and Process Management Branch II/Branch IV, OPRO, CDER, FDA
LCDR Kevin Denny, Pharm.D., Team Leader, Division of Project Manager, Office of Regulatory Operations, OGD, CDER, FDA
CDR Dat Doan, Pharm.D., Supervisory Project Manager, Division of Project Manager, Office of Regulatory Operations, OGD, CDER, FDA
Simon Eng, Pharm.D., Regulatory Business Process Manager, OPRO, OPQ, CDER, FDA
CDR Bob Gaines, Pharm.D., Division Director, Division of Regulatory and Business Process Management II, OPRO, OPQ, CDER, FDA
Valerie Gallagher, Senior Director, Consumer Healthcare Regulatory Affairs, Perrigo Company
TJ Garrigan, Associate Director, Policy and Strategic Alliances, GPhA
CAPT. Lillie D. Golson, MSA, Pharm.D., Deputy Director (Acting), Division of Labeling Review, Office of Regulatory Operations
OGD, CDER, FDA
Madhuri Gupta , Manager, Regulatory Affairs, Aveva Drug Delivery Systems
Mark Hendrickson, Director, Sciences & Regulatory Affairs, GPhA
Lyndsay Hennessey, PMP, Team Leader, Division of Project Manager, Office of Regulatory Operations, OGD, CDER, FDA
Missy Henry, Director, Regulatory Affairs, Sandoz Inc.
LCDR Kevin Herkenham, Pharm.D., BCPP, Regulatory Project Manager, Division of Project Manager, Office of Regulatory
Operations, OGD, CDER, FDA
CDR Thomas Hinchliffe, Pharm.D., Regulatory Affairs Coordinator, Immediate Office, OGD CDER, FDA
Evelyn Hong, Pharm.D., Program Manager, Applications Team Lead in the Generics Branch, Division of User Fee
Management and Budget Formulation, OM, CDER, FDA
Jasmeet (Mona) Kalsi, Pharm.D., Special Assistant, Office of Regulatory Operations, OGD, CDER, FDA
Savan Khanna, Pharm.D., Regulatory Business Project Manager, OPRO, OPQ, CDER, FDA
LCDR Andrew Kim, Pharm.D., Team Leader, Division of Project Manager, Office of Regulatory Operations, OGD, CDER, FDA
Edward Kim M.P.A., M.P.H., Regulatory Affairs Coordinator, Immediate Office, OGD CDER, FDA
Sonni Kim, Pharm.D., Branch Chief (Acting), Branch I, OPRO, OPQ, CDER, FDA
Dawn Kimble-Vance, R.Ph., Regulatory Project Manager, Division of Project Manager, Office of Regulatory Operations, OGD, CDER, FDA
LCDR Jessica Kreger, Pharm.D., Regulatory Project Manager, Division of Project Manager, Office of Regulatory Operations
OGD, CDER, FDA
Kiran Krishnan, Vice President, Regulatory Affairs, Apotex Corporation
LT Mandy Kwong, Pharm.D., Team Leader, Division of Project Manager, Office of Regulatory Operations, OGD, CDER, FDA
Hongly La, Pharm.D., Regulatory Business Project Manager, OPRO, OPQ, CDER, FDA
Erin Lee, Pharm.D., Regulatory Project Manager, Division of Project Manager, Office of Regulatory Operations, OGD, CDER, FDA
Heidi Lee, Pharm.D., Team Leader, Division of Project Manager, Office of Regulatory Operations, OGD, CDER, FDA
Carrie Lemley, Project Manager, Division of Labeling Review, Office of Regulatory Operations, OGD, CDER, FDA
Dianoda Lewis, MBA, Management Analyst, Facility Team in the Generics Branch, Division of User Fee Management
and Budget Formulation, OM, CDER, FDA
LCDR Chitra Mahadevan, Pharm.D., Senior Supervisory Regulatory Officer, Office of Bioequivalence, OGD, CDER, FDA
LCDR Nimmy Mathews, Pharm.D., Regulatory Project Manager, Division of Project Manager, Office of Regulatory Operations
OGD, CDER, FDA
Tania Mazza, Pharm.D., Regulatory Business Project Manager, OPRO, OPQ, CDER, FDA
Denise Toyer McKan, Division Director, Division of Project Manager, Office of Regulatory Operations, OGD, CDER, FDA
Laurie Mohler, R.Ph., CGP, FASCP, Project Manager, Division of Filing Review, Office of Regulatory Operations, OGD, CDER, FDA
Eileen Monaghan, Pharm.D., Regulatory Business Process Manager, OPRO, OPQ, CDER, FDA
Project Manager Exposition
3:00 p.m. - 6:00 p.m. - White Oak
Participants:
LCDR Filita Moore, RN, Regulatory Business Process Manager, OPRO, OPQ, CDER, FDA
Gwendolyn Murphy, Pharm.D., Regulatory Project Manager, Division of Project Manager, Office of Regulatory Operations, OGD, CDER, FDA
Victor Ng, Management Analyst, Applications Team Lead in the Generics Branch, Division of User Fee Management and Budget
Formulation, OM, CDER, FDA
LCDR Bic Nguyen, Pharm.D., BCPS, Team Leader, Division of Project Manager, Office of Regulatory Operations, OGD, CDER, FDA
Jennifer Nguyen, Pharm.D., Regulatory Business Process Manager, OPRO, OPQ, CDER, FDA
CDR Tina Nhu, Pharm.D., Team Leader, Division of Project Manager, Office of Regulatory Operations, OGD, CDER, FDA
Uzoma Nnebe, Pharm.D., Regulatory Project Manager, Division of Project Manager, Office of Regulatory Operations, OGD, CDER, FDA
Linda O'Dea, Executive Director, Regulatory Affairs, Sandoz Inc.
Gbenga Okubadejo, Pharm.D., Regulatory Business Process Manager, OPRO, OPQ, CDER, FDA
Marie Angeline O’Shea, RN, MBA, Associate Director for Science and Communications (Acting), OPRO, OPQ, CDER, FDA
CAPT Nitin Patel, Pharm.D., Senior BPM, Division of Clinical Review, Office of Bioequivalence, OGD, CDER, FDA
Gisa Perez, MBA, Generics Branch Chief, Division of User Fee Management and Budget Formulation, OM, CDER, FDA
Hanah Pham, Pharm.D., Program Manager, Facilities Team Lead in the Generics Branch, Division of User Fee Management and Budget
Formulation, OM, CDER, FDA
Tiffany Pokora, Pharm.D., Project Manager Team Lead (Acting), Division of Bioequivalence II, Office of Bioequivalence, OGD, CDER, FDA
LCDR Susan E. Polifko, Pharm.D., Project Manager Team Lead (Acting), Division of Filing Review, Office of Regulatory Operations
OGD, CDER, FDA
Catherine Poole, MS, Regulatory Project Manager, Division of Project Manager, Office of Regulatory Operations, OGD, CDER, FDA
LCDR Andrew Potter, Pharm.D., BCPP, Regulatory Project Manager, Division of Project Manager, Office of Regulatory Operations
OGD, CDER, FDA
LT Ryan Presto, Pharm.D., Team Leader, Division of Project Manager, Office of Regulatory Operations, OGD, CDER, FDA
Giuseppe Randazzo, M.S., Office Director (Acting), OPRO, OPQ, CDER, FDA
Carlene Randolph, BSN, MBA, Associate Director of Regulatory Affairs (Acting), Office of Regulatory Operations, OGD CDER, FDA
Peter Rickman, MA, Associate Director of Regulatory Affairs (Acting), Office of Regulatory Operations, OGD, CDER, FDA
Jorge Rondon, Organizational Excellence Branch Chief, Division III (Acting), OPRO,OPQ, CDER, FDA
Rhonda Rowell R.Ph., Project Manager, Division of Filing Review, Office of Regulatory Operations, OGD, CDER, FDA
LCDR Danielle E. Russell, Pharm.D., Project Manager, Division of Labeling Review, Office of Regulatory Operations, OGD, CDER, FDA
CDR Vince Sansone, Pharm.D., Supervisory Project Manager, Division of Project Manager, Office of Regulatory Operations, OGD, CDER, FDA
CDR Leigh Ann Sears. MAHS, BSN, Regulatory Business Process Manager, OPRO, OPQ, CDER, FDA
Priya Shah, Pharm.D., Team Leader, Division of Project Manager, Office of Regulatory Operations, OGD, CDER, FDA
Edward Sherwood, BS, Director (Acting), Office of Regulatory Operations, OGD, CDER, FDA
CAPT. Aaron Sigler, Pharm.D., BCPS, Deputy Division Director, Division of Project Manager, Office of Regulatory Operations, OGD, CDER, FDA
Manina Singh, Pharm.D., Project Manager, Division of Bioequivalence III, Office of Bioequivalence, OGD, CDER, FDA
LCDR Chad Snuggerud, Pharm.D., Regulatory Project Manager, Division of Project Manager, Office of Regulatory Operations, OGD, CDER, FDA
LCDR Diana Solana-Sodeinde Pharm.D., Senior Supervisory Project Manager (Acting), Office of Bioequivalence, OGD, CDER, FDA
Lisa Tan, R.Ph, Associate Vice President, Sciences & Regulatory Affairs, GPhA
Nicholas Tantillo, Head, Policy and Regulatory Strategy, Sandoz Inc.
Edward (Andrew) Taylor, Pharm.D., Regulatory Project Manager, Division of Project Manager, Office of Regulatory Operations
OGD, CDER, FDA
Margarita Tossa M.S., Senior BPM Lead (Acting), Division of Clinical Review, Office of Bioequivalence, OGD, CDER, FDA
Meghal Vakil, Project Leader, Regulatory Affairs, Apotex Corp.
Heidi Wilson, Director of Federal Government Affairs, GPhA
Lucie Yang, M.D., Ph.D., MBA, Division Director (Acting), Division of Quality Management Systems, Office of Regulatory Operations
OGD, CDER, FDA
Steven Yang, Pharm.D., Regulatory Business Process Manager, OPRO, OPQ, CDER, FDA
LCDR Martin Yoon, Pharm.D., Senior BPM Lead (Acting), Division of Bioequivalence I, Office of Bioequivalence, OGD, CDER, FDA
Ankara Nicole (Nikki) Yokum, Pharm.D., Regulatory Business Process Manager, OPRO, OPQ, CDER, FDA
6:00 p.m. – 7:30 p.m.
Networking Reception – Grand Ballroom Foyer
7:30 p.m. – 10:00 p.m.
70’s Disco Dinner Party and Entertainment – Salon A-E
Wednesday, November 4, 2015
7:00 a.m. – 8:30 a.m.
Networking Breakfast - Lower Level
Restricted Access Programs and Its Impact on
ANDAs and Patient Access
8:30 a.m. - 9:30 a.m. - Salon A-D
Drug Substance Review in OPQ/ONDP and
API Forum Introduction
8:30 a.m. - 8:50 a.m. - API Forum - Salon E-F
Moderator: Marcy Macdonald, RAC
Vice President, Regulatory Affairs, Impax Laboratories
Nicholas Tantillo
Head, Policy and Regulatory Strategy, Sandoz Inc.
Scott Furness, Ph.D.
Deputy Director, ONDP, OPQ, CDER, FDA
GDUFA Update/Completeness Assessments
Jayani Perera, Ph.D.
Review Chemist, Division of Lifecycle API
ONDP, OPQ, CDER, FDA
GDUFA Regulatory Science Update & Bioequivalence
Guidances
9:30 a.m. - 10:30 a.m. - Salon A-D
Moderator: Scott Tomsky
Vice President, Generic Regulatory Affairs, North America
Teva Pharmaceuticals
Robert Lionberger, Ph.D.
Director, Office of Research and Standards
OGD, CDER, FDA
Larissa Lapteva, M.D., M.H.S.
Director (Acting), Division of Therapeutic Performance
Office of Research and Standards, OGD, CDER, FDA
Project Management for DMF Review in OPQ
Truong Quach, Pharm.D.
Business Process Manager - Lifecycle API, OPRO
OPQ, CDER, FDA
Selected DMF Topics from the CDER DMF Expert
9:50 a.m. - 10:30a.m. - API Forum - Salon E-F
Arthur Shaw, Ph.D.
Review Chemist/DMF Expert, Division of New Drug
Products II, ONDP, OPQ, CDER, FDA
Networking Refreshment Break
10:30 a.m. - 11:00 a.m. – Grand Ballroom Foyer
IID Update - Next Steps
11:00 a.m. - 12:00 p.m. - Salon A-D
Electronic DMF Submissions/New Guidance
Moderator: Kiran Krishnan
Vice President, Regulatory Affairs, Apotex Corporation
David Schoneker
Director, Global Regulatory Affairs, Colorcon, Inc.
Priscilla Zawislak
Global Regulatory Affairs Manager, Ashland Inc.
Ginny Hussong
Director, Division of Data Management Service
and Solutions, OBI, CDER, FDA
Starting Material Selection for Type II
Drug Master Files
11:30 a.m. - 12:00 p.m. - API Forum - Salon E-F
Ronald Michalak, Ph.D.
Quality Assessment Lead (Acting), Division of Lifecycle
API, ONDP, OPQ, CDER, FDA
Dissolution - Biopharmaceutics Vision in
Office of New Drug Products
12:00 p.m. - 12:30 p.m. - Salon A-D
Open Panel Discussion
12:00 p.m. - 12:30 p.m. - API Forum - Salon E-H
Paul Seo, Ph.D.
Division Director (Acting), Division of Biopharmaceutics
Office of New Drug Products, OPQ, CDER, FDA
Moderator: Neeru Takiar
Quality Assessment Lead, Division of Lifecycle API
All Morning FDA Speakers:
Scott Furness, Ph.D.
Ginny Hussong
Ronald Michalak, Ph.D.
Jayani Perera, Ph.D.
Truong Quach, Pharm.D.
Arthur Shaw, Ph.D.
Fall Technical Conference Luncheon
12:30 p.m. - 1:45 p.m. – Lower Level
GDUFA’s Impact on eCTDs / Case Study:
Implementing PDF Standards
1:45 p.m. - 2:45 p.m. - Salon A-D
Risk Based Review for Drug Substance
Moderator: Kiran Krishnan
Vice President, Regulatory Affairs, Apotex Corporation
Meghan Hughes
Associate Director, Submission Ready Standards Program
Lead, Teva Pharmaceuticals
Kevin Tompkins
Director, Head of North America
Global Regulatory Operations, Teva Pharmaceuticals
Deborah Johnson, Ph.D.
Branch Chief, Life Cycle Branch I, ONDP, OPQ, CDER, FDA
ICH M7 Guidance
Stephen Miller, Ph.D.
CMC Lead, ONDP, OPQ, CDER, FDA
Bioequivalence Inspections: An Update from the
Office of Study Integrity and Surveillance
2:45 p.m. - 3:45 p.m. - Salon A-D
ICH M7 Impact on DMF Review
Moderator: Scott Tomsky
Vice President, Generic Regulatory Affairs, North America
Teva Pharmaceuticals
John Kadavil, Ph.D.
Pharmacologist, Office of Study Integrity and Surveillance
Office of Translational Sciences, CDER, FDA
Carmen Shepard, J.D.
Senior Vice President, Global Policy & Regulatory
Counsel, Mylan Inc.
David Green
Review Chemist and Quality Assessment Lead (Acting)
Division of Lifecycle API, ONDP, OPQ, CDER, FDA
Use of QSAR to Evaluate PGIs
Naomi Kruhlak, Ph.D.
Lead, Chemical Informatics Program, Division of Applied
Regulatory Sciences, OCP, OTS, CDER, FDA
Current Trends in Labeling and Best Practices
3:45 p.m. - 4:30 p.m. - Salon A-D
AMES Data Submissions and Other Qualification
Data for Impurities in DS
CAPT. Lillie D. Golson, MSA, Pharm.D.
Deputy Director (Acting), Division of Labeling Review
Office of Regulatory Operations, OGD, CDER, FDA
Mark Powley
Pharmacologist, ONDP, CDER, FDA
Open Panel Discussion
Moderator: Barbara Scott
Drug Substance Reviewer, Division of Lifecycle API
All Afternoon FDA Speakers:
David Green
Deborah Johnson, Ph.D.
Naomi Kruhlak, Ph.D.
Stephen Miller, Ph.D.
Mark Powley
Closing Remarks
4:30 p.m. - 4:35 p.m. - Salon A-D
Closing Remarks
David Gaugh, R.Ph.
Richard Stec, Ph.D.
Vice President, Global Regulatory Affairs
Perrigo Company
Conference Concludes
4:35 p.m.

Fall15 - Agenda - Generic Pharmaceutical Association

Transcription

Similar documents