Скачать с ютуб Regulatory Education for Industry (REdI) Annual Conference 2024: Day 1 – Session 2 в хорошем качестве

Regulatory Education for Industry (REdI) Annual Conference 2024: Day 1 – Session 2

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 01:01 – AI in Drug Development 30:36 – Q&A Session 40:09 – ClinicalTrials.gov: Meeting Transparency and Reporting Requirements 01:15:11 – Q&A Session Speakers: Tala Fakhouri, PhD, MPH Associate Director for Policy Analysis Office of Medical Policy (OMP) Center for Drug Evaluation and Research (CDER) | FDA Laurie Muldowney, MD Deputy Director Office of Scientific Investigations (OSI) Office of Compliance (OC) CDER | FDA Learn more at: https://www.fda.gov/drugs/news-events... ----------------------- 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 SBIA Listserv - https://public.govdelivery.com/accoun... SBIA 2024 Playlist -    • 2024 CDER Small Business and Industry...   SBIA LinkedIn -   / cder-small-business-and-industry-assistance   SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter -   / fda_drug_info   Email - [email protected] Phone - (301) 796-6707 I (866) 405-5367