Gaois

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  1. SOCIAL QUESTIONS|health|pharmaceutical industry
    sainchomhad iarratais ar thrialacha cliniciúla Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    sainchomhad iarratais Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Trí na nósanna imeachta nua maidir le húdarú trialacha cliniciúla, ba cheart taobhú leis an méid Ballstát agus is féidir a áireamh. Dá bhrí sin, ar mhaithe leis na nósanna imeachta a shimpliú maidir le tíolacadh sainchomhaid iarratais i dtaca le húdarú do thriail chliniciúil, ba cheart go seachnófaí faisnéis atá mar an gcéanna den chuid is mó a chur isteach arís agus arís eile agus ina ionad sin ba cheart aon sainchomhad iarratais amháin a chur isteach chuig na Ballstáit uile lena mbaineann trí thairseach tíolactha iarratais. I bhfianaise go bhfuil an tábhacht chéanna do thaighde cliniciúil Eorpach ag baint le trialacha cliniciúla a dhéantar i mBallstát aonair, ba cheart go ndéanfaí an sainchomhad iarratais do na trialacha cliniciúla sin a chur isteach freisin tríd an tairseach aonair sin.' Reference Rialachán (AE) Uimh. 536/2014 maidir le trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine, agus lena n-aisghairtear Treoir 2001/20/CE, CELEX:32014R0536/GA
    Antragsdossier für die klinische Prüfung | Antragsdossier
    de
    Definition Unterlagen, die der Sponsor den betroffenen Mitgliedstaaten seiner Wahl über das EU-Portal übermittelt, um eine Genehmigung für die Durchführung einer klinischen Prüfung zu erhalten Reference COM-DE nach: Verordnung (EU) Nr. 536/2014 des Europäischen Parlaments und des Rates vom 16. April 2014 über klinische Prüfungen mit Humanarzneimitteln und zur Aufhebung der Richtlinie 2001/20/EG Text von Bedeutung für den EWR
    clinical trial application dossier | application dossier for the authorisation of a clinical trial | CTA dossier | application dossier
    en
    Definition collection of documents that must be submitted by the sponsor through the EU clinical trial portal to the intended Member States concerned in order to obtain an authorisation to conduct a clinical trial Reference COM-Terminology Coordination, based on: - Articles 5(1) and 80 of Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use- European Medicines Agency. 'The EU clinical trial portal and database' (4.11.2020)