Transcription of EudraVigilance User Manual - European Medicines Agency
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Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands An Agency of the European Union Address for visits and deliveries Refer to Send us a question Go to Telephone +31 (0)88 781 6000 European Medicines Agency , 2021. Reproduction is authorised provided the source is acknowledged. 17 Feb 2021 EMA/167839/2016 EudraVigilance user Manual Marketing Authorisation Holders - EudraVigilance access via the EudraVigilance data analysis System electronic Reaction Monitoring Reports, Line Listings and Active Substance Grouping reports Version Contents Contents .. 2 Version .. 4 Overview .. 6 1. Introduction to the EudraVigilance data analysis System .. 7 EudraVigilance data analysis System .. 7 Source systems .. 7 ETL process .. 8 EudraVigilance data Warehouse .. 8 EVDAS interface .. 8 Introduction to EVDAS Terminology .. 9 2. EVDAS access to MAHs General principles.
EudraVigilance Data Analysis System . electronic Reaction Monitoring Reports, Line Listings and Active Substance ... Section 4.2.1.1. data reliability warning message deleted ... This manual provides guidance for Marketing Authorisation Holders (MAHs) on the use of the ...
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