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Marriott Wardman Park Hotel

27 ene 2020 7:00 a.m. - 29 ene 2020 4:15 p.m.

2660 Woodley Road, NW, , Washington, DC 20008 , USA

Pharmacovigilance and Risk Management Strategies Conference

Session 10: North America Region Updates

Session Chair(s)

Gerald  Dal Pan, MD, MHS

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

Session 10: North America Region Updates Session 86586

Gerald Dal Pan, MD, MHS

FDA, United States

Director, Office of Surveillance and Epidemiology, CDER

Sophie  Sommerer

Health Canada Updates

Sophie Sommerer

Health Canada, Canada

Director General

Steven A. Anderson, PhD

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

Howard  Chazin, MD, MBA

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

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