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Session 5: FDA Updates in Pharmacovigilance
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, updates on safety surveillance from the Office of Generic Drugs, and updates on Surveillance, Epidemiology, and Risk Management approaches for biologics from CBER.
Learning Objective : At the conclusion of this session, participants should be able to:
- Identify advances in pharmacolviligance and risk management strategies
- Examine the FDA assessment of emerging safety signals and review of safety data
- Discuss the regulatory landscape of safety surveillance for drug products including generics and biologics
Speaker(s)
An Update on CDER Pharmacoviligance and Risk Management Activities
Gerald Dal Pan, MD, MHS
FDA, United States
Director, Office of Surveillance and Epidemiology, CDER
An Update on CBER Biologics Pharmacovigilance and Risk Management Activities
Representative Invited
FDA, United States
Update on Safety Surveillance for Generic Drugs
Howard Chazin, MD, MBA
FDA, United States
Director, Division of Clinical Safety and Surveillance, OSCE, OGD, CDER