EudraVigilance training on electronic reporting of individual case safety reports in the European Economic Area

• Date:
  Monday, 21 September 2015, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

This training course covers all aspects on the functionalities of the EudraVigilance system specificallyEVWEB, with regard to electronic reporting of individual case safety reports (ICSRs) including practical examples and exercises in theEudraVigilance training environment. It includes fundamentals of electronic transmission of ICSRs andICH M2 safety and acknowledgment message specifications, as well as ICH E2B(R2) specificationson 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