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Search results with tag "Individual case safety"
Guideline on good pharmacovigilance practices (GVP)
www.ema.europa.eu- Addition of an explanatory note for Good pharmacovigilance practices for the European Union with regard to ... - Addition of the legal reference to the definition of Individual case safety report and deletion of the footnote ... Solicited sources of individual case safety reports ..... 28 Spontaneous report, synonym: Spontaneous notification ...
EU Individual Case Safety Report (ICSR)1 …
www.ema.europa.eu1 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