Regulatory Education for Industry (REdI) Annual Conference 2024: Day 1 - Keynote and Plenary

Описание к видео Regulatory Education for Industry (REdI) Annual Conference 2024: Day 1 - Keynote and Plenary

Content in this video provided updates and cutting-edge insight on novel artificial intelligence (AI), clinical trial designs and innovative strategies, safety data in clinical trials, combination products, electronic submissions and more. Subject matter experts provided insight on FDA’s perspectives, adoption of regulatory guidelines, opportunities for stakeholders to engage with CDER and best practices.

Timestamps

00:49 – Keynote Speaker

27:33 – Plenary

Keynote Speaker:

Robert M. Califf, MD, MACC
Commissioner
U.S. Food and Drug Administration (FDA)

Plenary Speakers:

Patrizia Cavazzoni, MD
Director
Center for Drug Evaluation and Research (CDER)

Jeff Shuren, MD, JD
Director
Center for Devices and Radiological Health (CDRH)

Peter Marks, MD, PhD
Director
Center for Biologics Evaluation and Research (CBER)

Learn more at: https://www.fda.gov/drugs/news-events...

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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

Upcoming Training - https://www.fda.gov/cdersbia
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