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Postmarket Safety Surveillance: Tools, Methods, and Benefit-Risk Framework - Pharmacovigilance 2020

Eileen Wu and Judith Zander from CDER’s Office of Pharmacovigilance and Epidemiology (OPE) describe risk-based principles, available tools, and methods for postmarket safety surveillance. They provide the fundamentals of benefit-risk assessment in the drug regulatory context, with an introduction to the FDA’s Benefit-Risk Framework and its implementation into postmarketing processes. _______________________________ 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 and free continuing education credits: https://www.fda.gov/cdersbia CDER SBIA 2020 Playlist:    • 2020 CDER Small Business and Industry...   LinkedIn:   / cder-small-business-and-industry-assistance   Training resources: https://www.fda.gov/cderbsbialearn Twitter:   / fda_drug_info   CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionm... Email: [email protected] Phone: (301) 796-6707 I (866) 405-5367