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Pharmacovigilance and Risk Management Strategies Conference

NEW! The 2019 meeting will be a full three days, allowing maximum learning opportunities!

Session 1: FDA Updates

Session Chair(s)

Gerald J. Dal Pan, MD, MHS

Gerald J. 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 post-marketing 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 J. Dal Pan, MD, MHS

Gerald J. Dal Pan, MD, MHS

  • Director, Office of Surveillance and Epidemiology, CDER
  • FDA, United States
Steven A. Anderson, PhD

An FDA-CBER Update on Surveillance, Epidemiology, and Risk Management Approaches for Biologics

Steven A. Anderson, PhD

  • Director, Office of Biostatistics and Epidemiology, CBER
  • FDA, United States
Karen Feibus, DrMed, MD

Updates in Generic Drug Pharmacovigilance

Karen Feibus, DrMed, MD

  • Lead Medical Officer, Drug-Device Combination Team, Division of Therapeutic Perf
  • FDA, United States
James Osterhout

Updates in Generic Drug Pharmacovigilance

James Osterhout

  • Scientist
  • FDA, United States

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Preconference Short Courses

Short Course 1: Introduction to Pharmacoepidemiology

Short Course 2: Pharmacovigilance and Risk Management Planning

Short Course 3: Reference Safety Information

Short Course 4: Combination Therapies

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