Gaois

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2 results

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

    #666530

    IATE #3623643
    triail chliniciúil ilnáisiúnta 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 triail chliniciúil ar chuir an t-urraitheoir sainchomhad iarratais faoi bhráid níos mó ná Ballstát amháin ina leith trí thairseach an Aontas 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"
    multinationale klinische Prüfung
    de
    Definition "klinische Prüfung, für die der Sponsor ein Antragsdossier an mehr als einen Mitgliedstaat über das EU-Portal übermittelt hat" Reference COM-internes Dokument: SANTE-2021-81060 (klinische Prüfungen)
    multi-national clinical trial
    en
    Definition "clinical trial for which the sponsor submitted an application dossier to more than one Member State through the EU portal" 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"
  2. SOCIAL QUESTIONS|health|pharmaceutical industry|pharmaceutical product|medicament · PRODUCTION, TECHNOLOGY AND RESEARCH|research and intellectual property|research|scientific research

    #666536

    IATE #3623651
    substaint ghníomhach ilnáisiúnta 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 substaint ghníomhach a úsáidtear i dtáirge íocshláinte imscrúdaitheach i dtriail chliniciúil nó i dtrialacha cliniciúla a údaraítear i níos mó ná aon Bhallstát amháin 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"
    multinationaler Wirkstoff
    de
    Definition "Wirkstoff, der in einem Prüfpräparat in (einer) klinischen Prüfung(en) verwendet wird, die in mehr als einem Mitgliedstaat genehmigt wurde(n)" Reference COM-internes Dokument: SANTE-2021-81060 (klinische Prüfungen)
    multi-national active substance
    en
    Definition "active substance which is used in an investigational medicinal product in a clinical trial or trials authorised in more than one Member State" 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"