Veronique Basch to tackle safety reports at DIA

Veronique Basch, Head of drug safety at HPM, will present a tutorial on Annual Safety Reports (ASRs) at the Drug Information Association (DIA) clinical forum. The tutorial to be held on 20 October in Ljubljana, Slovenia, will help participants navigate guidelines on requirements for writing the reports.

The requirements for Annual Safety Reports (ASRs) are outlined in the European Commission’s guidance, CT 3, but according to Dr Basch “these requirements do not provide a template or detailed instructions and thereby leave plenty of room for interpretation”.

She will present a flexible ASR template structured to include and evaluate all relevant safety findings. The discussion on the template will take into account CIOMS VII and highlight the links between ASRs, PSURs, RMPs and benefit-risk analyses.

Dr Basch will also talk on the same topic at a session on risk management plans.

15 October 2008