Search results with tag "Individual case safety report"
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 ...
EudraVigilance - EVWEB User Manual
www.ema.europa.euagreed to use the International Organization for Standardization (ISO) Individual Case Safety Report (ICSR) standard ISO EN 27953-2:2011 to meet the reporting requirements for E2B(R3). EVWEB, one of the functional components of EudraVigilance (see section 1.4.4. EVWEB), has been re-written to support ICH E2B(R3) messages.
NIHS 医薬品安全性情報 Vol.19 No.25202112/09/
www.nihs.go.jp個別症例安全性報告（individual case safety report：ICSR）を収載したWHOのグローバルデータベース。 ICSR に関する詳細情報（限界や適切な使用など）は，“
EudraVigilance User Manual - European Medicines …
www.ema.europa.euThe main objective of this user manual is to provide information to users regarding the new Individual Case Safety Report form (ICSR form). Section 1 provides an introduction and the general principles