#2 - Development Safety Update Reports (DSURs): Principles and Practicalities

Jan 13 2013 8:30AM - Jan 13 2013 12:00PM | Renaissance Washington DC Downtown Hotel 999 Ninth Street NW Washington, DC 20001

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Overview

The new ICH E2F guideline on the Development Safety Update Report (DSUR) was signed off in August 2010 and came into force in Europe in September 2011. This new report will replace the current European clinical trial Annual Safety Report and, in the other ICH regions is intended to be a common standard for periodic reporting on drugs under development (including marketed drugs that are under further study.

At the conclusion of this activity, participants should be able to:

Discuss the main principles defined in the ICH E2F guideline
Describe the structure and content of the DSUR
Discuss how a DSUR can be prepared
Review the implementation process of the DSUR

Instructor(s)

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Michael Richardson, MD,FFPM

International Head GPV&E and EU QPPV
Bristol-Myers Squibb, United Kingdom

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

Participants with Disabilities:
Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.

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