ClinicalTrials.gov: Part 3 - CDER’s Compliance and Enforcement Activities

Описание к видео ClinicalTrials.gov: Part 3 - CDER’s Compliance and Enforcement Activities

Part three of a three-part webinar series, FDA provides an understanding of CDER’s role and responsibilities with respect to ClinicalTrials.gov oversight; including examples of compliance and enforcement activities CDER has taken to encourage compliance.

Speakers:

Rachelle Swann, Pharm.D.
Lead Pharmacologist
Division of Enforcement and Postmarketing Safety (DEPS)
Office of Scientific Investigations (OSI)
Office of Compliance (OC)
Center for Drug Evaluation and Research (CDER) | FDA


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.

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