Quick Overview: Learn directly from the FDA's regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed ... Kevin Bugin, Deputy Director for Operations for the Office of New Drugs (OND) provides a background and overview of the ... Robert M. Califf, MD, Commissioner of Food and Drugs at FDA, delivers the keynote address to the 2022 Regulatory Education for ...
Cber Redi Annual Conference 2026 - Detailed Overview & Context
Learn directly from the FDA's regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed ... Kevin Bugin, Deputy Director for Operations for the Office of New Drugs (OND) provides a background and overview of the ... Robert M. Califf, MD, Commissioner of Food and Drugs at FDA, delivers the keynote address to the 2022 Regulatory Education for ... Keynote Address Dr JoAnn Rolle Former Dean, School of Business, Medgar Evers College, CUNY, USA; J. D. Rolle & Associates, ... FDA experts: *Review the new BsUFA III commitments, focusing on supplement categories and associated timelines, guidance ... Kerry Jo Lee, MD, Associate Director for Rare Diseases in the Office of Rare Diseases, Pediatrics, Urologic and Reproductive ...
The keynote provided an overview to updates and cutting-edge insight on novel artificial intelligence (AI), clinical trial designs and ... FDA discusses considerations and best practices throughout a human drug recall life cycle including when to conduct a recall, ... Suranjan De, Deputy Director of Regulatory Science Staff (RSS) in the Office of Surveillance & Epidemiology (OSE) presents on ...
