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Session 10: North America Region Updates
Session Chair(s)
Gerald 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 Dal Pan, MD, MHS
Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Session 10: North America Region Updates Session 86586
Sophie Sommerer
Director General, Marketed Health Products Directorate, Health Canada, Canada
Health Canada Updates
Steven A. Anderson, PHD
Director, Office of Biostatistics and Epidemiology, CBER, FDA, United States
An FDA-CBER Update on Surveillance, Epidemiology and Risk Management Approaches for Biologics
Howard Chazin, MD, MBA
Director, Division of Clinical Safety and Surveillance, OSCE, OGD, CDER, FDA, United States
Challenges in Postmarketing Safety and Surveillance of Generic Drugs