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2024 Combo Products Summit Workshop

session

Hot Topics for Combination Products

October 8, 2024 @ 3:15 pm

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5:15 pm

Speakers

Nish Gupta, Senior Regultory Program Director, Genentech
Willy Liou, Director of Regulatory Affairs, Amgen
Amanda Matthews, Senior Director, Regulatory CMC for Combination Products and Medical Devices, Pfizer
John McMichael, Director, Medical Devices & Combination Products, AstraZeneca
Abhishek Telang, Principal Scientist, Merck
Andrea Redd, Associate Vice President, Global Regulatory Affairs, Drug Delivery & Combination Products, Lilly
Suzette Roan, Associate VP, Head of GRA Devices, Sanofi

Facilitators

Jason Lipman, Senior Director, Global Regulatory Affairs, Devices and Combination Products, Sanofi

Hemal Mehta, Associate Director, Global CMC Regulatory Affairs, Medical Devices & Combination, Johnson & Johnson

Come join in the fun and engage with a panel of combination product regulatory experts from across industry as they share approaches, strategies, and case studies on key regulatory topics. This will be a lively, interactive, and collaborative session. The discussion will span a range of topics including CP development and submission strategy from clinical to post-market, including strategies and approaches related to clinical studies, clinical bridging, phase-appropriate testing, human factors, control strategies, and more.

This conference IS co-sponsored by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services. The contents are those of the presenters and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. government.

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.

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© 2024 AFDO/RAPS Healthcare Products Collaborative