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