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

Date: 06/11/2019 to 08/11/2019
Location: San Marino

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

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