Hot Topics for Combination Products

2024 Combo Products Summit Workshop

session

October 8, 2024 @ 3:15 pm

5:15 pm

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

Speakers

Nish Gupta, Senior Regultory Program Director, Genentech

Willy Liou, Director of Regulatory Affairs, Amgen
Amanda Matthews, Executive Director, Head of GRS Medical Devices, Pfizer

John McMichael, Director, Medical Devices & Combination Products, AstraZeneca

Abhishek Telang, Director, Device Quality and Regulatory, Merck

Andrea Redd, Associate Vice President, Global Regulatory Affairs, Drug Delivery & Combination Products, Lilly

Suzette Roan, Associate VP, Head of GRA Devices, Sanofi

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.

2024 Combo Products Summit Workshop

session