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 .. 5 EudraVigilance (EV) .. 5 Main Functional Components of EudraVigilance .. 6 EudraVigilance Database Management System (EVDBMS).
EudraVigilance also provides advice on the measures to ensure the safe and ... (i.e. the pre- and post-authorisation phase). These processes include clinical studies, reports of spontaneous adverse reactions, events, regulatory submissions and regulated product information.
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