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Sheraton Philadelphia University City

Oct 23, 2017 3:45 AM - Oct 25, 2017 3:45 PM

3549 Chestnut Street, Philadelphia, PA 19104

Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

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Session 21: Aggregate Reporting for Marketed Products

Session Chair(s)

Jill W. Buckley, PharmD

Adjunct Assistant Professor

Rutgers, the State University of New Jersey, United States

This session will address postmarketing periodic reports, including the US Periodic Adverse Drug Experience Report (PADER) and the EU Periodic Safety Update Report (PSUR in ICH Periodic Benefit Risk Evaluation Report format).