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Session 2: Postmarket Considerations
Session Chair(s)
Steven B. Binion
Director, Policy, Technology, and Communication - Corporate Regulatory Affairs
Becton Dickinson, United States
The intent of FDA’s Final rule on Current Good Manufacturing Practices (CGMP) requirements for combination products was to help ensure that CGMP requirements that apply to single-entity and co-packaged combination products are clear and consistent, regardless of which Agency component has lead jurisdiction for the combination product, or which type of application is submitted for marketing authorization. The final rule also provides an approach that combination product manufacturers can take to streamline demonstrating compliance with CGMP requirements for these types of combination products. In this session, FDA representatives from OCP, CDER, CBER, CDRH, and ORA will share an update based on their experiences in working with combination product manufacturers on CGMP issues and answer questions from the audience in an interactive panel format.
Speaker(s)
Current Good Manufacturing Practices for Combination Products: Final Rule in Brief
John Weiner, JD
FDA, United States
Associate Director for Policy, Office of Combination Products, OCPP, OC
Steven Hertz, MBA, MS
FDA, United States
Consumer Safety Officer, Office of Pharmaceutical Quality, CDER
Melissa Torres, MS
FDA, United States
Associate Director for International Affairs, CDRH
Melissa Burns, MS
FDA, United States
Senior Program Manager, Office of Combination Products, OCPP, OC
M. Isabel Tejero del Rio, MD, PhD
FDA, United States
Quality Systems Working Group Lead, DMQ, OC, CDRH
Additional FDA Speakers Invited
United States
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