Transcription of EU Individual Case Safety Report (ICSR)1 …
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EU Individual Case Safety Report (ICSR)1 …
6 July 2017. EMA/51938/2013 Rev 1*. EU Individual case Safety Report ( icsr ) 1 Implementation Guide Start of Public Consultation of first version 30 April 2014. End of Public Consultation of first version 30 June 2014. Final draft of first version agreed by Project Team 1 10 October 2014. Final draft of first version agreed by Project Coordination Group 19 November 2014. Final draft of first version endorsed by European Risk Management 27 November 2014. Strategy Facilitation Group First version adopted by Pharmacovigilance Risk Assessment Committee 4 December 2014.
1 EN ISO 27953-2:2011 Health Informatics, Individual case safety reports (ICSRs) in pharmacovigilance — Part 2: Human pharmaceutical reporting requirements for ICSR (ISO 27953-2:2011) and the ICH E2B(R3) Implementation Guide
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