Gaois

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2 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #622808

    IATE #1226337
    dea-chleachtas cliniciúil Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Tabharfar tuairisc ar aon oiliúint a fuarthas roimhe sin i bprionsabail an dea-chleachtais chliniciúil nó ar aon taithí a fuarthas ó obair i mbun trialacha cliniciúla agus ar chúram othar.' 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"
    gute klinische Praxis
    de
    good clinical practice | GCP
    en
    Definition set of detailed ethical and scientific quality requirements for designing, conducting, performing, monitoring, auditing, recording, analysing and reporting clinical trials ensuring that the rights, safety and well-being of subjects are protected, and that the data generated in the clinical trial are reliable and robust Reference "Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC"
    Comment Compliance with this standard provides public assurance that the rights, safety and wellbeing of trial subjects are protected and that clinical-trial data are credible.
    bonne pratique clinique | BPC | bonnes pratiques cliniques
    fr
    Definition ensemble de dispositions qui garantissent la qualité dans la conduite d'un essai, le recueil des résultats, les droits et la sécurité des personnes participantes, ainsi que la confidentialité des informations Reference Act Up-Paris,Gloss.sida,janvier 1998
  2. SOCIAL QUESTIONS|health|health policy|organisation of health care|pharmaceutical legislation · EUROPEAN UNION|EU institutions and European civil service|EU office or agency|European Medicines Agency

    #668029

    IATE #3629741
    cigireacht maidir le dea‑chleachtas cliniciúil Reference Téarmeolaithe COM-GA
    ga
    Context 'Le haghaidh aon chigireacht shainiúil maidir le Dea‑chleachtas Cliniciúil lasmuigh den Aontas, beidh feidhm ag táille EUR 44 200. Beidh an luach saothair cothrom le EUR 19 600 le haghaidh an phríomhúdaráis maoirseachta agus le EUR 10 400 le haghaidh an údaráis maoirseachta tacaíochta.' Reference "Togra le aghaidh Rialachán maidir le táillí agus muirir is iníoctha leis an nGníomhaireacht Leigheasra Eorpach, lena leasaítear Rialachán (AE) 2017/745 ó Pharlaimint na hEorpa agus ón gComhairle agus lena n‑aisghairtear Rialachán (CE) Uimh. 297/95 ón gComhairle agus Rialachán (AE) 658/2014 ó Pharlaimint na hEorpa agus ón gComhairle,CELEX:52022PC0721/GA"
    Good Clinical Practice inspection
    en
    Definition "inspection intended to achieve the verification of compliance with the principles of 'good clinical practice'" Reference "COM-Terminology Coordination, based on: Regulation (EC) No 726/2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency"