ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Virtual live hands-on training course using the EudraVigilance System
EventHumanRegulatory and procedural guidancePharmacovigilance
Date
- Monday, 6 July 2020, All day
Location
- OnlineEuropean Medicines Agency, Amsterdam, the Netherlands
The training course includes a knowledge evaluation for which participants, who pass the evaluation, will receive a notification from the EMA. Organisations, which aim to use EudraVigilance web application (EVWEB) to start the electronic reporting of ICSRs to EudraVigilance for the first time, need to provide such notification for at least one user to be able to successfully register with the EudraVigilance production environment.