Transcription of EudraVigilance - EVWEB User Manual
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EudraVigilance - EVWEB User Manual
30 Churchill Place Canary Wharf London E14 5EU United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website European Medicines Agency, 2022. Reproduction is authorised provided the source is acknowledged. 14 March 2021 EMA/501718/2018 Data Analytics and Methods Task Force EudraVigilance - EVWEB user Manual Version corr. EudraVigilance - EVWEB user Manual EMA/501718/2018 Page 2/104 Summary of changes: Section Figure 132 and Table updated EudraVigilance - EVWEB user Manual EMA/501718/2018 Page 3/104 Table of Contents Table of Contents .. 3 1. Introduction .. 5 About this user Manual .. 5 Typographical Conventions.
agreed to use the International Organization for Standardization (ISO) Individual Case Safety Report (ICSR) standard ISO EN 27953-2:2011 to meet the reporting requirements for E2B(R3). EVWEB, one of the functional components of EudraVigilance (see section 1.4.4. EVWEB), has been re-written to support ICH E2B(R3) messages.
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