EudraVigilance training on electronic reporting of ICSRs in the EEA

• Date:
  Monday, 24 April 2017, 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 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 currentEudraVigilance Business Rules.

Documents

Agenda and registration form - EudraVigilance training on electronic reporting of ICSRs in the European Economic Area

Summary:

This training course covers all aspects on the functionalities of the EudraVigilance system specifically

EVWEB with regard to electronic reporting of ICSRs including practical examples and exercises in the

EudraVigilance training environment.