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Drug Safety and Pharmacovigilance Across the Product Lifecycle

Build a solid foundation in the key concepts of drug safety and pharmacovigilance throughout the medical product development lifecycle. Learn how to comply with regulatory requirements.


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

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 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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