Regulatory Education for Industry (REdI) Annual Conference 2024: Day 1 – Session 1

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

01:55 – Selective Safety Data Collection in Clinical Trials

29:59 – Q&A Session

44:45 – Enhancing Clinical Trial Innovation

01:10:29 – Q&A Session

Speakers:

Mary T. Thanh Hai, MD
Deputy Director for Clinical
Office of New Drugs (OND)
Center for Drug Evaluation and Research (CDER) | FDA

Kevin Bugin, PhD, MS, RAC
Deputy Director
OND | CDER | FDA

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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.

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