ISO/ICH E2B(R3) Individual case safety report (ICSR) in the EU: Virtual live hands-on training course using the EudraVigilance system

Date: 07/09/2020 to 11/09/2020
Location: Virtual meeting

This hands-on training course covers:

  • in-depth explanation and practical examples of creating, sending and accessing ICSRs in the ISO/ICH E2B(R3) format based on the EU ICSR Implementation Guide;
  • EudraVigilance web application (EVWEB) functionalities to describe the use of the E2B(R3) format and to provide examples of various reporting scenarios;
  • reporting principles in accordance with the Guideline on 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. 

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