Become a member

Cart (0)

Already a DIA Member? Sign in. Not a member? Join.

Not a Member?

Create Account and Join

Bethesda North Marriott Hotel and Conference Center

Apr 08, 2019 1:45 PM - Apr 10, 2019 9:45 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Drug Safety and Pharmacovigilance Across the Product Lifecycle

Back to Agenda

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

Session Chair(s)

Mark Vieder, MBA, RPh

Vice President, Drug Safety and Pharmacovigilance

Biorasi, LLC, 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.