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The NEW EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: H

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good

pharmacovigilance practices (GVP) Module VI “Management and reporting of adverse reactions to

medicinal products” and explanations on how to comply with the EudraVigilance business rules and

the EudraVigilance Access Policy.


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