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Seaport Hotel

Aug 12, 2019 7:45 AM - Aug 14, 2019 4:00 PM

One Seaport Lane, Boston, MA 02210

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.

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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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