EudraVigilance training on electronic reporting of individual case safety reports in the European Economic Area
Event
Date
- Monday, 12 October 2015, All day
Location
- European Medicines Agency, Amsterdam, the Netherlands
his training course covers all aspects on the functionalities of the EudraVigilance system specifically 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 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.