Preparing The Development Safety Update Report

Course review:

In September 2011, the Development Safety Update Report (DSUR), based on the ICH E2F guideline, became a regulatory requirementin Europe, replacing the Annual Safety Report (ASR). The latter is no longer referenced in the update to ‘CT3’* published in June 2011, being replaced with a simple reference to ICH E2F.

Regulatory expectations from this more detailed report are much greater than the simple ASR. You will require support from data management, pre-clinical, clinical development and safety/pharmacovigilance to
provide the required information, prepare and approve this far more detailed report within the regulatory time frame.

This course will cover expectations of the DSUR, practical aspects of preparation and the links with the risk management plans.

* “Communication from the Commission — Detailed guidance on the collection, verification and presentation of adverse event/ reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’)”