Associate Director, Global CMC-Regulatory Affairs, Medical Devices and Combination Products Johnson & Johnson
Back by popular demand! 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 target 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, post-approval changes, control strategies, and more.