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