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