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Session 1: FDA Updates
Session Chair(s)
Gerald Dal Pan, MD, MHS
Director, Office of Surveillance and Epidemiology, CDER
FDA, United States
FDA representatives will provide updates from the Office of Surveillance and Epidemiology (OSE) within CDER and the Office of Biostatistics and Epidemiology in CBER. Topics will include post-marketing safety monitoring, an overview of pharmacoepidemiology, pharmaceutical risk management, medication error prevention, and updates on safety surveillance from the Office of Generic Drugs.
Speaker(s)
Gerald Dal Pan, MD, MHS
FDA, United States
Director, Office of Surveillance and Epidemiology, CDER
An FDA-CBER Update on Surveillance, Epidemiology, and Risk Management Approaches for Biologics
Steven A. Anderson, PhD
FDA, United States
Director, Office of Biostatistics and Epidemiology, CBER
Updates in Generic Drug Pharmacovigilance
Karen Feibus, DrMed, MD
FDA, United States
Lead Medical Officer, Drug-Device Combination Team, Division of Therapeutic Perf
Updates in Generic Drug Pharmacovigilance
James Osterhout
FDA, United States
Scientist