The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course

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TitleThe new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course
Date13/09/2017 - 15/09/2017
LocationEuropean Medicines Agency, London, UK
SummaryThe European Medicines Agency (EMA) will launch a new EudraVigilance system with enhanced functionalities for reporting and analysing suspected adverse reactions in November 2017. The system will make use of the individual case safety report (ICSR) standards developed by the International Organization for Standardization (ISO), in collaboration with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). 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 ISO/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.

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Malgorzata Durka-Grabowska
malgorzata.durka-grabowska@ema.europa.eu