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The Westin Boston Waterfront

Aug 15, 2016 8:00 AM - Aug 17, 2016 4:00 PM

425 Summer Street, Boston, MA 02210

Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

Session 8: Assessing Individual Cases and Expedited Case Reporting, Part 2

Session Chair(s)

William  Gregory, PhD

William Gregory, PhD

Senior Director, Safety and Risk Management

Pfizer Inc, United States

This session will provide a comparative overview of US and EU requirements, including sponsor review of investigator safety data. Several gnarly examples will be presented for group discussion.

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