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2013-06-04 GPhA

Tuesday, June 4, 2013:

Evolution in FDA's Approach to Pharmaceutical Quality
Janet Woodcock, M.D.
Director, CDER, FDA

CMC Initiative Development for New and Generic Drugs
Lawrence Yu, Ph.D.
Deputy Director (acting), Office of Pharmaceutical Science, CDER, FDA

OGD Update - CMC
Susan Rosencrance, Ph.D.
Deputy Director of Chemistry (acting), OGD, FDA

Stability Considerations
Suhas Patankar, Ph.D.
Team Leader, OGD, FDA

Further Stability Considerations
Radhika Rajagopalan, Ph.D.
Team Leader, OGD, FDA

Industry Perspective on Stability Requirements
Nick Cappuccino, Ph.D.
Vice President and Head of Global Quality, Dr. Reddy’s Laboratories, Ltd.

Status Update on the Review of DMFs
Dave Skanchy, Ph.D.
Division Director, DMF, OGD, FDA

Quality by Design for Generic Drugs
Daniel Peng, Ph.D.
CMC Reviewer/QbD Liaison, OGD, FDA

Industry Perspective on Quality by Design
Alison Sherwood
Associate Director, Regulatory Affairs, Sandoz Inc.

Update on Question based Review (QbR)
Jennifer Maguire, Ph.D.
Chemist, OGD, FDA

QbR for Drug Master File Review
Huyi Zhang, Ph.D.
Deputy Division Director (acting), DMF, OGD, FDA

QbR for Micro Review
Marla Stevens-Riley, Ph.D.
Team Leader (acting), Micro, OGD, FDA

Wednesday, June 5, 2013:

Introduction to Day 2
Kathleen Uhl, M.D.
Director (acting), OGD, FDA

Review Considerations for Transdermal Patches
Bhagwant Rege, Ph.D.
Team Leader, OGD, FDA

Review Considerations for Peptide Products
Larisa Wu, Ph.D.
Chemist, OGD, FDA

Review Considerations for Liposomal Products
Ben Zhao, Ph.D.
Product Quality Reviewer, OGD, FDA

Review Considerations for Topical Dosage Forms
Bing Cai, Ph.D.
Deputy Division Director, OGD, FDA

Review Considerations for Nasal/Inhalation Products
Bita Mirzai-Azarm, M.S.
Team Leader, OGD, FDA

Review Considerations for Co-Crystals
Andre Raw, Ph.D.
Division Director, Chemistry Division I, OGD, FDA

GDUFA Regulatory Science
Rob Lionberger, Ph.D.
Deputy Director of Science (acting), OGD, FDA

Major/Minor MAPP 5241.1
Paul Schwartz, Ph.D.
Associate Director for Product Quality Coordination, OGD, FDA

Communication in the Regulatory Process
Robert Iser, M.S.
Division Director, Chemistry Division IV, OGD, FDA

Communication from the FDA: Industry Perspective
Kiran Krishnan
Vice President, Regulatory Affairs, Apotex Corporation

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