The new EudraVigilance system and the electronic reporting of individual case safety reports (ICSRs) in the ISO/ICH E2B(R3) format: hands-on training course
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Dată
- Luni, 9 octombrie 2017, Toată ziua
Locația
- European Medicines Agency, Amsterdam, the Netherlands
This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new International Organization for Standardization (ISO)/ the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI “Management and reporting of adverse reactions to medicinal products” and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy. The new EudraVigilance system and enhanced functionalities will go live in November 2017.