Tutorial 12: Development Safety Update Report (DSUR) Kick-off in 2011: Then and Know

The Development Safety Update Report (DSUR), introduced in 2011, is a much more comprehensive report with new sections, also requiring more input from various departments within a company. During the DSUR writing process, good oversight and project coordination is crucial. During the tutorial the various sections of the DSUR will be addressed. Examples of challenges faced will be presented and approaches towards handling of specific challenges as observed in various companies. The modular approach and the interface with the PSUR and Risk Management Plan (RMP) will be addressed. Managing a DSUR project will also be an important section of this tutorial.

• PV staff and medical staff involved in medical writing of DSURs
• PV staff and medical staff involved in medical writing of other periodic reports (PSURs, RMPs)
• Clinical/Regulatory and other staff involved in medical writing of DSURs
• Staff involved in the review of DSURs
  

At the conclusion of this tutorial, attendees will be able to:

• Manage a DSUR project effectively and efficiently
• Explain the general principles of DSUR preparation and submission
• Describe the relationship between the DSUR and the Periodic Safety Update Report (PSUR)
• Outline the content of DSUR sections as described in ICH E2F guideline
• Interpret the guidelines and translate into practice