Drug Safety and Pharmacovigilance Across the Product Lifecycle

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Session 10: Aggregate Reporting for Clinical Trials: Development Safety Update Report

Session Chair(s)

Jill W. Buckley, PharmD

Adjunct Assistant Professor

Rutgers, the State University of New Jersey, United States

This session will cover the Development Safety Update Report (DSUR) required in the EU and include a description of the modifications required for the DSUR submission to FDA in lieu of the IND Annual Report.

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Drug Safety and Pharmacovigilance Across the Product Lifecycle

Session 10: Aggregate Reporting for Clinical Trials: Development Safety Update Report

Session Chair(s)

Jill W. Buckley, PharmD

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