Training on electronic reporting of individual case safety reports (ICSRs) to EudraVigilance in the European Economic Area

• Date:
  Wednesday, 21 September 2016, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

This training course covers all aspects on the functionalities of the EudraVigilance system, specifically EVWEB, the web interface tool for the electronic reporting of ICSRs, with practical examples and exercises in the EudraVigilance training environment. The training will include the fundamentals of electronic transmission of ICSRs and the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) M2 safety and acknowledgment message specifications as well as the ICH E2B(R2) specifications on clinical safety data management in the frame of good pharmacovigilance practices and the current EudraVigilance business rules.

Documents

Agenda - EudraVigilance training on electronic reporting of Individual Case Safety Reports (ICSRs) in the European Economic Area (EEA)