Gaois

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  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #670040

    IATE #43785
    tuarascáil sábháilteachta maidir le cás aonair Reference Téarmeolaithe COM-GA
    ga
    tuairisc shábháilteachta do chás ar leith Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Sicherheitsberichte für Einzelfälle
    de
    ICSR | ICSRs | individual case safety report
    en
    Definition report of information describing adverse events or reactions experienced by an individual patient, in which the events or reactions can be related to the administration of one or more medicinal products at a particular point in time Reference "COM-EN, based on: European Medicines Agency. ICH guideline E2B (R3) Electronic transmission of individual case safety reports (ICSRs) - implementation guide - data elements and message specification. 2011. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002767.pdf [28.3.2012]"
    Comment "The ICSR can also be used for exchange of other information, such as medication errors that do not involve adverse events or reactions. See also:adverse event [ IATE:1863780 ] adverse reaction [ IATE:1146946 ]"
    rapport individuel d'effets indésirables | observation individuelle d'effets indésirables | ICSR
    fr
    Definition rapport d'information décrivant les effets indésirables subis par un patient Reference COM-FR