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Hyatt Regency Bethesda

Mar 19, 2018 5:45 AM - Mar 21, 2018 3:00 PM

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

Drug Safety and Pharmacovigilance Across the Product Lifecycle

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Session 21: Aggregate Reporting for Marketed Products

Session Chair(s)

Jill W. Buckley, PharmD

Jill W. Buckley, PharmD

Adjunct Assistant Professor

Rutgers, the State University of New Jersey, United States

This session will address post-marketing 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).

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