SOCIAL QUESTIONS|health|health policy
- measúnú cliniciúil comhpháirteach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- Context 'Tá an togra comhréireach agus riachtanach sa mhéid a dtugtar aghaidh ann ar na fadhbanna a luaitear i roinn 1. Chun an dúbailt oibre a laghdú agus neamhréireachtaí a sheachaint, tá gá, go háirithe, leis an gceanglas atá beartaithe gan measúnuithe cliniciúla comhpháirteacha a rinneadh ar leibhéal an Aontais a dhéanamh arís ar an leibhéal náisiúnta agus maidir leis an measúnú cliniciúil comhpháirteach féin gan ach an fhianaise atá ann a mheas. Ag an am céanna, áiritheofar leis an togra nach dtiocfar trasna ar inniúlachtaí na mBallstát maidir le cinntí faoin rochtain ar na teicneolaíochtaí sláinte sin a rinneadh a mheas ar leibhéal an Aontais. Tríd an obair chomhpháirteach a dhíriú ar na gnéithe cliniciúla den mheasúnú ar theicneolaíochtaí sláinte, nuair is féidir cur le cáilíocht agus le héifeachtúlacht tríd an gcomhar ar leibhéal an Aontais, ní théann an togra seo thar an méid atá riachtanach. Is ar leibhéal an Bhallstáit go fóill a dhéantar an measúnú ar réimsí áirithe a bhaineann níos mó le comhthéacs sonrach (e.g. réimsí eacnamaíocha, eagrúcháin, eitice) agus na cinntí i dtaobh praghsála agus aisíocaíochta.' Reference "Togra le haghaidh Rialachán maidir le measúnú ar theicneolaíochtaí sláinte agus lena leasaítear Treoir 2011/24/AE, CELEX:52018PC0051/GA"
- measúnú ar éifeachtacht choibhneasta chomhpháirteach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- joint clinical assessment | joint REA | joint relative clinical assessment | joint relative effectiveness assessment
- en
- Definition clinical assessment carried out by the Coordination Group on certain medicinal products, medical devices and in vitro diagnostic medical devices according to Section 1 of Chapter II of EU Regulation on health technology assessment Reference "COM-Terminology Coordination and COM-CS, based on:Regulation (EU) 2021/2282 of the European Parliament and of the Council on health technology assessment"
- Comment "See also: - clinical assessment [ IATE:1638698 ]- Coordination Group [ IATE:3575681 ]- medicinal products [ IATE:1443220 ]- medical devices [ IATE:1442463 ]- in vitro diagnostic medical devices [ IATE:886911 ]- HTA [ IATE:2247146 ]- Joint REA/Joint clinical assessment [ IATE:3575682 ]- REA/clinical assessment [ IATE:1638698 ] In order to carry out such an assessment, the Coordination Group designates a subgroup which then appoints an assessor and a co-assessor.COM-Terminology Coordination and COM-CS, based on:Regulation (EU) 2021/2282 of the European Parliament and of the Council on health technology assessment The joint clinical assessments for HTA purposes will only be completed after the products have obtained a marketing authorisation (for medicines) or a CE mark (for medical devices). HTA does not interfere with marketing authorisation assessments (of medicines) or conformity assessments (of medical devices).Reference: European Commission. Fact Sheet. Q&A: Commission proposal on Health Technology Assessment, http://europa.eu/rapid/press-release_MEMO-18-487_en.htm [26.02.2018]Do not confuse Joint REA/Joint clinical assessment (assessment carried out at EU level by the coordination group via its sub-group dedicated to JCAs) with REA/clinical assessment (assessment carried out by an individual HTA body) Reference: European Commission. DG Health and Food Safety (SANTE). Correspondence dated 7.2.2018"
- évaluation clinique commune
- fr
- Definition "Site de la Commission Européenne > Communiqués de presse > Details Communiqué de presse: Commission européenne - Fiche d'information (MEMO/18/487) — Q&R: Proposition de la Commission concernant l'évaluation des technologies de la santé (31.1.2018), http://europa.eu/rapid/press-release_MEMO-18-487_fr.htm [9.2.2018]"
- Comment évaluation clinique réalisée par le groupe de coordination des États membres sur l’évaluation des technologies de la santé sur certains médicaments, dispositifs médicaux et dispositifs médicaux de diagnostic in vitro décrits à l’article 5 du règlement concernant l’évaluation des technologies de la santé