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EUROPEAN UNION|EU institutions and European civil service|EU office or agency|European Medicines Agency
an Tascfhórsa Éigeandála Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
ga
Comhthéacs 'Le linn éigeandáil sláinte poiblí, déanfaidh an Tascfhórsa Éigeandála athbhreithniú ar phrótacail trialacha cliniciúla a chuireann forbróirí táirgí íocshláinte isteach, nó a bheartaíonn siad a chur isteach, in iarratas ar thriail chliniciúil mar chuid de phróiseas comhairle eolaíche luathaithe.' Tagairt Togra le haghaidh Rialachán maidir le ról treisithe don Ghníomhaireacht Leigheasra Eorpach in ullmhacht agus bainistiú géarchéimeanna do tháirgí íocshláinte agus d’fheistí leighis, CELEX:52020PC0725/GA
Emergency Task Force | ETF
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Sainmhíniú task force established within the European Medicines Agency which will be be convened in preparation for and during public health emergencies and undertake the following tasks:(a) in liaison with the scientific committees, working parties, and scientific advisory groups of the Agency, providing scientific advice and reviewing the available scientific data on medicinal products that have the potential to address the public health emergency, including requesting data from developers and engaging with them in preliminary discussions;(b) providing advice on the main aspects of clinical trial protocols, and providing advice to developers on clinical trials for medicinal products intended to treat, prevent or diagnose the disease causing the public health emergency, in accordance with Article 16 of this Regulation without prejudice to the tasks of the Member States as regards the assessment of submitted clinical trial applications to be conducted within their territories in accordance with Regulation (EU) No 536/2014;(c) providing scientific support to facilitate clinical trials for medicinal products intended to treat, prevent or diagnose the disease causing the public health emergency;(d) contributing to the work of the scientific committees, working parties and scientific advisory groups of the Agency;(e) in liaison with the scientific committees, working parties, and scientific advisory groups of the Agency, providing scientific recommendations with regard to the use of any medicinal product which have the potential to address public health emergencies, in accordance with Article 18;(f) cooperating with national competent authorities, Union bodies and agencies, the World Health Organization, third countries, and international scientific organisations, on scientific and technical issues that relate to the public health emergency and to medicinal products which have the potential to address public health emergencies, as necessary Tagairt COM-Terminology Coordination and COM-CS, based on:Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices