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The Development Safety Update Report (DSUR): Practical Experience for Medical Writers
Session Chair(s)
Julia Cooper, PhD
Corporate Vice President, Head of Global Medical Writing Services
Parexel International, Ireland
The Development Safety Update Report (DSUR) is the required format for pre-approval annual safety reports in Europe, and is accepted by FDA in place of the IND annual report. This session will review practical experience with the DSUR as it relates to medical writers. Presentations will include case studies illustrating lessons learned for DSUR preparation, from the pharma company and CRO perspectives.
Learning Objective : At the conclusion of this session, participants should be able to: - Apply the required content and timing of the DSUR - Discuss the pitfalls of preparing a DSUR and describe the key role of the medical writer in overcoming them - Summarize the status of DSUR implementation and discuss the benefits and challenges of this harmonization
Speaker(s)
Faculty
Julia Cooper, PhD
Parexel International, Ireland
Corporate Vice President, Head of Global Medical Writing Services
Faculty
Kathy Thomas-Urban, PhD
Medical & Technical Writing & Publication Services, Germany
Medical and Scientific Writer
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