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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 postmarketing 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)
New Developments in Pharmacovigilance
Gerald Dal Pan, MD, MHS
FDA, United States
Director, Office of Surveillance and Epidemiology, CDER
An FDA Update on Pharmacovigilance and Risk Management Approaches for CBER-Regulated Biologic Products
Steven A. Anderson, PhD
FDA, United States
Director, Office of Biostatistics and Epidemiology, CBER
Experiences in Safety and Surveillance of Generic Drugs
John Peters, MD
FDA, United States
Deputy Director, Office of Generic Drugs, CDER
Speaker
Howard Chazin, MD, MBA
FDA, United States
Director, Division of Clinical Safety and Surveillance, OSCE, OGD, CDER