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Pharmacovigilance and Risk Management Strategies Conference


Session 10: North America Region 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
Representatives the Food and Drug Administration (FDA) and Health Canada (HC) will provide updates on post-marketing safety monitoring, an overview of pharmacoepidemiology, pharmaceutical risk management, and medication error prevention. FDA presenters are from the Office of Surveillance and Epidemiology (OSE) and the Office of Generic Drugs within CDER, and the Office of Biostatistics and Epidemiology in CBER. The Health Canada presenter is from Health Canada’s Biotechnology and Natural Health Products Bureau.

Speaker(s)

Gerald J. Dal Pan, MD, MHS

Session 10: North America Region Updates Session 86586

Gerald J. Dal Pan, MD, MHS

  • Director, Office of Surveillance and Epidemiology, CDER
  • FDA, United States
Sophie  Sommerer, MS

Health Canada Updates

Sophie Sommerer, MS

  • Director
  • Health Canada, Canada
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
Howard  Chazin, MD, MBA

Challenges in Postmarketing Safety and Surveillance of Generic Drugs

Howard Chazin, MD, MBA

  • Director, Clinical Safety Surveillance Staff, Office of Generic Drugs, CDER
  • FDA, United States