Regulatory Education for Industry (REdI) Annual Conference 2024: Day 1 – Session 3 [Video]

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

00:37 – Diversity in Clinical Trials: Drug Trials Snapshot Perspective

21:11 – Q&A Session

32:42 – Combination Products – Updates and Best Practices

01:03:23 – Q&A Session

Speakers:

Aden S. Asefa, MPH
Drug Trials Snapshot Lead
Office of Drug Evaluation Sciences (ODES)
Office of New Drugs (OND)
Center for Drug Evaluation and Research (CDER) | FDA

Kristina Lauritsen, PhD
Combination Product Regulatory Advisor
Product Jurisdiction and Combo Product Team
Office of Executive Programs (OEP)
CDER | FDA

Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/regulatory-education-industry-redi-annual-conference-2024-innovation-medical-product-development

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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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