European Medicines Agency Information Day: The New Individual Case Safety Report (ICSR) Internationa

Venue: European Medicines Agency

Location: London, United Kingdom

Event Date/Time: Jun 25, 2010
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The European Medicines Agency is organising this public awareness event to update medicines regulatory authorities, pharmaceutical companies and IT vendors about the new international Individual Case Safety Report (ICSR) standard and the intended implementation at ICH level.

The ISO Draft International Standard (DIS) will be subject to balloting in May 2010 with a final International Standard (IS) expected by the end of 2010. In parallel, a release of the ICH ICSR Implementation Guide for Step 2 consultation is planned in the 2nd half of 2010. For the first time, the wider pharmacovigilance stakeholder community including IT vendors will have the opportunity to review and comment on the implementation of the new standard at ICH level.

EU and US experts, who have been strongly involved in the standards development and in the drafting of the ICH ICSR Implementation Guide will outline the technical and process related aspects that need to be taken into account in preparing for a coordinated, well-organised approach in putting the new standard in operation.