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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
Syneos Health, United States
Senior Vice President, Clinical Operations
A Practical Approach to Compiling the DSUR
Mari Ylipelkonen Welke, MA
Yellow Pelican Writing & Consulting, L.L.C., United States
Owner