The Development Safety Update Report (DSUR): Practical Experience for Medical Writers

Track:
Medical Writing Regulatory Topics

Day & Time:
March 20, 3:30PM - 5:00PM

Room Number:
Kave Ballroom One

Type:
Session

Title:
The Development Safety Update Report (DSUR): Practical Experience for Medical Writers

Chair(s):
Julia Cooper, PhD
Senior Director, Worldwide Head of Medical Writing Services
PAREXEL International Ltd., United Kingdom

Description:
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(s):
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

Presentation(s) & Speaker(s):
Faculty
Julia Cooper, PhD
Senior Director, Worldwide Head of Medical Writing Services
PAREXEL International Ltd., United Kingdom

Faculty
Kathy B Thomas-Urban, PhD
Medical and Scientific Writer
Medical & Technical Writing & Publication Services, Germany