Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

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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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Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

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

Session Chair(s)

Jill W. Buckley, PharmD

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