ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - San Marino

• Date:
  Wednesday, 6 November 2019, All day
• Location:
  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

Documents

Agenda and registration - ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - San Marino