ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Amsterdam
EventPharmacovigilance
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Date
- Mercredi, 4 mars 2020, Journée Entière
Emplacement
- European Medicines Agency, Amsterdam, the Netherlands
This hands-on training course covers:
- In depth explanation and practical examples for creating, sending and accessing ICSRs in the ISO/ICH E2B(R3) format based on the EU ICSR Implementation Guide
- The use of the EudraVigilance web application (EVWEB) functionalities to describe the use of the E2B(R3) format and to practice examples for various reporting scenarios
- Reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI “Management and reporting of adverse reactions to medicinal products”
- How to comply with the EudraVigilance business rules and the EudraVigilance 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)
- Instruction on using the ICSR download functionality for MAHs to access ICSRs