Drug Safety and Pharmacovigilance Across the Product Lifecycle

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Session 16: 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 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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Drug Safety and Pharmacovigilance Across the Product Lifecycle

Session 16: Aggregate Reporting for Marketed Products

Session Chair(s)

Jill W. Buckley, PharmD

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