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Virtual

Jan 26, 2021 9:45 AM - Jan 28, 2021 5:00 PM

(US Eastern Standard Time)

Pharmacovigilance and Risk Management Strategies Conference

Session 5: FDA Updates in Pharmacovigilance

Session Chair(s)

Gerald  Dal Pan, MD, MHS

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)

Gerald  Dal Pan, MD, MHS

An Update on CDER Pharmacoviligance and Risk Management Activities

Gerald Dal Pan, MD, MHS

FDA, United States

Director, Office of Surveillance and Epidemiology, CDER

Representative Invited

An Update on CBER Biologics Pharmacovigilance and Risk Management Activities

Representative Invited

FDA, United States

Howard  Chazin, MD, MBA

Update on Safety Surveillance for Generic Drugs

Howard Chazin, MD, MBA

FDA, United States

Director, Division of Clinical Safety and Surveillance, OSCE, OGD, CDER

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