EudraVigilance training on electronic reporting of individual case safety reports
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Ημερομηνία
- Δευτέρα, 5 Δεκέμβριος 2016, Ολοήμερο
Τοποθεσία
- European Medicines Agency, Amsterdam, the Netherlands
This training course covers all aspects on the functionalities of the EudraVigilance system specifically EVWEB with regard to electronic reporting of of individual case safety reports (ICSR) 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. The Agency updates the course content regularly to comply with new regulations and requirements.