Automated Segregation of Relevant ICSRs from EudraVigilance
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Automated Segregation of Relevant ICSRs from EudraVigilance
One of the key requirements of the new pharmacovigilance legislation (Regulation 726/2004) in the EU is simplified reporting of individual case safety reports (ICSRs) by a Marketing Authorization Holder (MAH) to the new EudraVigilance (EV) system
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