Gaois

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3 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #569855

    IATE #2222817
    frithghníomh trom díobhálach amhrasta neamhthuartha Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    mutmaßliche unerwartete schwerwiegende Nebenwirkung
    de
    suspected unexpected serious adverse reaction | serious suspected unexpected adverse drug reaction | SUSAR | suspected serious unexpected adverse drug reaction
    en
    Definition suspected adverse reaction related to an investigational medicinal product which occurs in the course of a clinical trial, and which is both unexpected and serious Reference COM-EN, based on:Voisin Consulting Life Sciences (VCLS) > resources > glossary > suspected unexpected serious adverse reaction (SUSAR) (9.3.2022)
    Comment Reports of these reactions are subject to expedited submission to health authorities.
    suspicions d'effets indésirables graves inattendus | SUSAR
    fr
  2. SOCIAL QUESTIONS|health|pharmaceutical industry

    #526874

    IATE #137520
    frithghníomh trom díobhálach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    schwerwiegende Nebenwirkung
    de
    Comment Term defined -- Term defined --
    serious adverse reaction
    en
    Definition adverse reaction [ IATE:1146946 ] that is life-threatening; results in death or a persistent or significant disability or incapacity; manifests itself as a congenital anomaly/birth defect; or, in the case of the treatment of humans, requires inpatient hospitalisation or prolongation of existing hospitalisation or, in the case of the treatment of animals, results in permanent or prolonged signs in the animals treated Reference EP-EN Terminology, based on:- Directive 2001/83/EC on the Community code relating to medicinal products for human use, CELEX:32001L0083/EN - Directive 2001/82/EC on the Community code relating to veterinary medicinal products, CELEX:32001L0082/EN
    effet indésirable grave
    fr
  3. SOCIAL QUESTIONS|health|pharmaceutical industry

    #582130

    IATE #3543181
    frithghníomh trom díobhálach neamhthuartha Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    unerwartete schwerwiegende Nebenwirkung
    de
    Definition schwerwiegende Nebenwirkung, deren Art, Schweregrad oder Ergebnis nicht den Referenzinformationen zur Unbedenklichkeit entspricht Reference COM-Internes Dokument SANCO-2012-80155-00-01 (Verordnung über klinische Prüfungen mit Humanarzneimitteln)
    unexpected serious adverse reaction
    en
    Definition serious adverse reaction [ IATE:137520 ] the nature, severity or outcome of which is not consistent with the reference safety information Reference Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, CELEX:32014R0536/EN
    effet indésirable grave et inattendu
    fr
    Definition effet indésirable grave [ IATE:137520 ] dont la nature, la gravité ou l'issue ne concorde pas avec les informations de référence relatives à la sécurité Reference COM-Document interne: SANCO-2012-80155-00-04BR>Règlement relatif aux essais cliniques de médicaments à usage humain