EudraVigilance training on electronic reporting of Individual Case Safety Reports in the European Economic Area

• Date:
  Monday, 16 March 2015, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

This training course covers all aspects of the functionalities of the EudraVigilance system, specifically the data-entry tool EVWEB, with regard to electronic reporting of Individual Case Safety Reports (ICSRs), including practical examples and exercises in the EudraVigilance training environment. It includes fundamentals of electronic transmission of ICSRs and International Conference on Harmonisation (ICH) M2 safety and acknowledgment message specifications, as well as ICH E2B(R2) specifications on clinical safety data management in the frame of good pharmacovigilance practices and current EudraVigilance business rules. Places limited.

Documents

Agenda and registration form - EudraVigilance training on electronic reporting of Individual Case Safety Reports in the European Economic Area (Vienna, Austria)

Reference Number: Course #15519