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Session 4: FDA Updates in Pharmacovigilance
Session Chair(s)
Cheryl Campbell, MS
Associate Director of Executive Operations/Outreach and Communications, OSE,CDER
FDA, United States
Jamie Ridley Klucken, PharmD, MBA, RPh
Safety Evaluator, Division of Pharmacovigilance, OSE, 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)
The 2022 Update on CDER Pharmacoviligance and Risk Management Activities
Gerald Dal Pan, MD, MHS
FDA, United States
Director, Office of Surveillance and Epidemiology, CDER
Updates and Opportunities for Generic Drug Postmarketing Surveillance
Howard Chazin, MD, MBA
FDA, United States
Director, Division of Clinical Safety and Surveillance, OSCE, OGD, CDER
An FDA-CBER Update on Surveillance, Epidemiology and Risk Management Approaches for COVID-19 Vaccines
Steven A. Anderson, PhD
FDA, United States
Director, Office of Biostatistics and Epidemiology, CBER