Course Overview

The Periodic Safety Reports: PSURs/PBRERs and Introduction to DSURs course covers the rationale and theory behind the evolution of these reports. It offers an understanding of the respective International Conference on Harmonisation (ICH) guidelines (E2C and E2F), and practical advice designed to give you a working knowledge of planning and writing them. Group sessions and workshops will discuss the practical application of the guidelines to emerging data on drug products. Issues such as the planning and writing of reports, and the evaluation of the emerging data will be addressed, particularly the challenges of writing the benefit-risk assessment section of the report.

This course has been developed for those who have no previous training in writing PSURs/PBRERs and/or DSURs, as well as those who have a basic knowledge which they wish to improve.