European Medicines Agency Information Day: The New Individual Case Safety Report (ICSR) International Standard and ICH E2B/M2

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.

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.

Event Code:
10568