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Medical Affairs and Scientific Communications Forum
Session 3 Track 2: DSUR Best Practices: Empowering Medical Writers to Create ICH-compliant Development Safety Update Reports
Session Chair(s)
Andrea Tuttle Meyers
- Senior Vice President, Clinical Operations
- Syneos Health, United States
The Development Safety Update Report (DSUR) is a document written by medical writers; however, there are two distinct pathways required to develop an ICH-compliant DSUR – the process of gathering the information required and the task of compiling the information into the DSUR template. This session will address DSUR best practices for the medical writer to ensure a process is in place to drive the production of the deliverable. Common pitfalls, misconceptions and “tips and tricks” for writing the DSUR will be shared, with audience participation encouraged.
Learning Objective : At the conclusion of this session, participants should be able to:
- Identify key stakeholders required for a successful DSUR
- Develop timelines to manage the acquisition of data for the DSUR
- Create an ICH-compliant DSUR within the 60-day regulatory requirement
Speaker(s)
Why the DSUR is Not a Medical Writing Deliverable
Andrea Tuttle Meyers
- Senior Vice President, Clinical Operations
- Syneos Health, United States
A Practical Approach to Compiling the DSUR
Mari A Welke Ylipelkonen Welke, MA
- Owner
- Yellow Pelican Writing & Consulting, L.L.C., United States
Contact us
Registration Questions?
Preconference Short Courses
Medical Communications Primer: The Fundamentals of Medical Communications
Short Course #1: Medical Communications: Compliance in 2022
Short Course #2: Advertising and Promotional Content Review: The Role of Medical Information
Short Course #3: Statistics for Non-Statisticians
Additional Information
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