Gaois

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  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #582554

    IATE #3544929
    oibreán dúshláin 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 ;Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    challenge agent
    en
    Definition agent usually given to trial subjects in the framework of a clinical trial to produce a physiological response that is necessary before the pharmacological action of the investigational medicinal product (IMP) can be assessed Reference COM-Terminology Coordination, based on:European Commission. Health and Consumers Directorate-General. The Rules Governing Medicinal Products in the European Union. VOLUME 10 – Guidance Documents Applying to Clinical Trials. Guidance on Investigational Medicinal Products (IMPS) and 'Non-Investigational Medicinal Products' (NIMPS) (Rev. 1, March 2011), http://ec.europa.eu/health//sites/health/files/files/eudralex/vol-10/imp_03-2011.pdf [2.3.2017]