Gaois

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3 results

  1. 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
  2. PRODUCTION, TECHNOLOGY AND RESEARCH|research and intellectual property|research|scientific research · SOCIAL QUESTIONS|health|pharmaceutical industry

    #599894

    IATE #3623652
    scagthástáil a dhéanamh ar fhrithghníomhartha díobhálacha tromchúiseacha neamhthuartha amhrasta Reference Rialachán Cur Chun Feidhme (AE) 2022/20 lena leagtar síos rialacha maidir le cur i bhfeidhm Rialachán (AE) Uimh. 536/2014 ó Pharlaimint na hEorpa agus ón gComhairle a mhéid a bhaineann le bunú na rialacha agus na nósanna imeachta um chomhar idir na Ballstáit sa mheasúnú sábháilteachta ar thrialacha cliniciúla, CELEX:32022R0020/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Definition frithghníomhartha díobhálacha tromchúiseacha neamhthuartha amhrasta a shainaithint go córasach, ar frithghníomhartha iad lena gceanglaítear measúnú as a dtiocfaidh cinneadh maidir leis an ngá atá le fógra a thabhairt do na Ballstáit tuairiscithe agus do na Ballstáit lena mbaineann Reference Rialachán Cur Chun Feidhme (AE) 2022/20 lena leagtar síos rialacha maidir le cur i bhfeidhm Rialachán (AE) Uimh. 536/2014 ó Pharlaimint na hEorpa agus ón gComhairle a mhéid a bhaineann le bunú na rialacha agus na nósanna imeachta um chomhar idir na Ballstáit sa mheasúnú sábháilteachta ar thrialacha cliniciúla, CELEX:32022R0020/GA
    Überprüfung von mutmaßlichen unerwarteten schwerwiegenden Nebenwirkungen
    de
    Definition systematische Feststellung von mutmaßlichen unerwarteten schwerwiegenden Nebenwirkungen, die eine Bewertung und anschließende Entscheidung darüber erfordern, ob eine Unterrichtung der berichterstattenden Mitgliedstaaten sowie der betroffenen Mitgliedstaaten erforderlich ist Reference COM-internes Dokument: SANTE-2021-81060 (klinische Prüfungen)
    screening of suspected unexpected serious adverse reactions
    en
    Definition systematic identification of suspected unexpected serious adverse reactions that require an assessment leading to a decision on the need to notify the reporting Member States and Member States concerned Reference Commission Implementing Regulation (EU) 2022/20 laying down rules for the application of Regulation (EU) No 536/2014 as regards setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials
  3. 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