ISO/ICH E2B(R3) Individual case safety reporting in the EU: Hands-on training course using the EudraVigilance system
EventHumanQuality of medicines
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Datum
- Pondělí, 2 Prosinec 2019, All day
Místo
- European Medicines Agency, Amsterdam, the Netherlands
This hands-on training course covers:
- an in-depth explanation and practical examples of how to create, send and access individual case safety reports (ICSRs) in the ISO/ICH E2B(R3) format following the EU ICSR Implementation Guide;
- the use of the EudraVigilance web application (EVWEB) functionalities to describe the use of the E2B(R3)ICSR format and to practice examples for various reporting scenarios;
- reporting principles in accordance with the 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.