ISO/ICH E2B(R3) Individual case safety report (ICSR) in the EU: Virtual live hands-on training course using the EudraVigilance system (7-11 Dec 2020)
EventHumanPharmacovigilanceQuality of medicines
Date
- Monday, 7 December 2020, All day
Location
- OnlineEuropean Medicines Agency, Amsterdam, the Netherlands
This hands-on training course covers:
- in-depth explanation and practical examples of creating, sending and accessing ICSRs in the ISO/ICH E2B(R3) format based on the EU ICSR Implementation Guide;
- EudraVigilance web application (EVWEB) functionalities to describe the use of the E2B(R3) format and to provide examples of various reporting scenarios;
- reporting principles in accordance with the Guideline on Good Pharmacovigilance Practice (GVP) Module VI 'Management and reporting of adverse reactions to medicinal products';
- how to comply with the EudraVigilance business rules and access policy;
- training on the transmission of ICSRs in the E2B(R3) format via the EudraVigilance Gateway, including WebTrader (EVWEB, EV Post and Gateway Traders)
- instructions on using the ICSR download functionality for marketing authorisation holders to access ICSRs.