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Session 2 Track A: Challenges with Lifecycle Management
Session Chair(s)
Cheryl Watson
Bristol-Myers Squibb, United States
The registration and approval of new medicines requires extensive information regarding the manufacture and control of the medicinal product to be provided to global health authorities. Throughout the life of a product, this information must be maintained and post-approval changes (PACs) are subject to oversight by the global health authorities. Requirements from global health authorities differ widely with regards to data requirements and timelines, which has resulted in increased complexity for ensuring uninterrupted supply of medicines. Manufacturers need to make timely changes to improve the quality and supply of medicines, to implement new technologies, and to maintain facilities; however, implementing these changes is complicated by the divergence of global regulatory requirements and approval timelines.
Learning Objective : At the conclusion of this session, participants should be able to:- Understand how global regulatory requirements may impact supply
- Understand the complexity of managing a globally registered medicinal product or vaccines
Speaker(s)
CMC Supplements/Variations and Shortages Partnering with Regulatory Agencies
Diane Hustead, MS
Merck & Co., Inc., United States
Executive Director, Regulatory Affairs
Speaker
Hasmukh Patel, PhD
FDA, United States
Director, OLDP, OPQ, CDER
Speaker
Paul Schwartz, PhD
FDA, United States
Director, Division of Post- Marketing Activities II, OLDP, OPQ, CDER
Unique Aspects of Lifecycle Management
Cheryl Watson
Bristol-Myers Squibb, United States
Case Study on a Global Post-Approval Change
Bill Garden
Amgen, United States