EATRIS, la Infraestructura Europea per a la Medicina Traslacional, acaba d’anunciar la seva participaci\u00f3 al grup assessor en el projecte ‘COMBINE’, una iniciativa destinada a proporcionar claredat i alineaci\u00f3 en la interf\u00edcie entre els assaigs cl\u00ednics de medicaments en investigaci\u00f3, els estudis de rendiment de diagn\u00f2stic vitro i investigacions cl\u00edniques de dispositius m\u00e8dics.<\/p>\n
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COMBINE \u00e9s una iniciativa liderada per l’Ag\u00e8ncia Europea de Medicaments (EMA) i l’IDIBELL i l’Istituto Mario Negri, amb seu a Mil\u00e0, actuaran com a Centre Expert d’EATRIS, exercint un paper crucial com a part del grup de refer\u00e8ncia del projecte.<\/p>\n
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Hi ha un nombre cada cop m\u00e9s gran de consultes adre\u00e7ades a les autoritats competents en relaci\u00f3 amb el disseny i la presentaci\u00f3 d’assajos cl\u00ednics que involucren medicaments i dispositius m\u00e8dics o diagn\u00f2stics in vitro. Les autoritats competents en mat\u00e8ria de productes sanitaris tamb\u00e9 s’han enfrontat a q\u00fcestions an\u00e0logues. En recon\u00e8ixer la urg\u00e8ncia d’abordar aquests desafiaments, diverses organitzacions interessades s’han acostat a la Comissi\u00f3 Europea i han expressat la preocupaci\u00f3 pels retards en la realitzaci\u00f3 d’estudis combinats a la Uni\u00f3 Europea. Aquests retards es deuen principalment a la complexa interacci\u00f3 regulat\u00f2ria entre el Reglament d’Assaigs Cl\u00ednics (CTR), el Reglament de Diagn\u00f2stic In Vitro (IVDR) i el Reglament de Dispositius M\u00e8dics (MDR).<\/p>\n
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El projecte ‘COMBINE’ pret\u00e9n afrontar aquests reptes de front. Els reglaments MDR, IVDR i CTR contenen requisits espec\u00edfics per a cada tipus de projecte. Tot i que els estudis combinats s\u00f3n essencials per garantir que els tractaments innovadors siguin accessibles per als pacients, la interacci\u00f3 d’aquests procediments ha presentat un repte important. Una interacci\u00f3 m\u00e9s fluida entre aquestes regulacions no nom\u00e9s beneficiaria les autoritats reguladores sin\u00f3 que tamb\u00e9 reduiria la c\u00e0rrega per als patrocinadors i, en \u00faltima inst\u00e0ncia, beneficiaria els pacients.<\/p>\n
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Aix\u00ed doncs, ‘COMBINE’ busca aclarir i alinear la interf\u00edcie entre els assaigs cl\u00ednics de medicaments en investigaci\u00f3, els estudis de rendiment de diagn\u00f2stics in vitro i les investigacions cl\u00edniques de dispositius m\u00e8dics. Durant la fase d’an\u00e0lisi inicial, el projecte se centrar\u00e0 a comprendre els desafiaments i els obstacles que obstaculitzen l’alineament dels tres marcs reguladors que es creuen en estudis combinats. ‘COMBINE’ proposar\u00e0 solucions efectives per abordar aquests problemes de manera integral.<\/p>\n
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El Dr. Miguel \u00c1ngel Souto Mora, Director de l’\u00c0rea de Desenvolupament de Negoci i Innovaci\u00f3 de l’IDIBELL, va expressar el seu entusiasme per participar en aquesta iniciativa i va afirmar: “El projecte ‘COMBINE’ representa un pas endavant vital en la millora del panorama regulatori. Fomentant la col\u00b7laboraci\u00f3 i l’alineament entre aquests marcs regulatoris cr\u00edtics, podem facilitar el desenvolupament i el lliurament de tractaments innovadors als pacients de manera m\u00e9s eficient\u201d.<\/p>\n","protected":false},"excerpt":{"rendered":"
L\u2019IDIBELL, juntament amb sis institucions m\u00e9s, \u00e9s un Centre Expert per EATRIS, la infraestructura europea per a la medicina translacional. Aquest segell ens permet oferir serveis d\u2019alt valor afegit que abans realitzava Coordinaci\u00f3 i Suport d\u2019EATRIS.<\/p>\n","protected":false},"author":8,"featured_media":24384,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"default","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[493],"tags":[],"class_list":["post-24383","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-innovacio"],"publishpress_future_action":{"enabled":false,"date":"2025-01-29 10:34:48","action":"change-status","newStatus":"draft","terms":[],"taxonomy":"category"},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"_links":{"self":[{"href":"https:\/\/idibell.cat\/wp-json\/wp\/v2\/posts\/24383","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/idibell.cat\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/idibell.cat\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/idibell.cat\/wp-json\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/idibell.cat\/wp-json\/wp\/v2\/comments?post=24383"}],"version-history":[{"count":1,"href":"https:\/\/idibell.cat\/wp-json\/wp\/v2\/posts\/24383\/revisions"}],"predecessor-version":[{"id":24385,"href":"https:\/\/idibell.cat\/wp-json\/wp\/v2\/posts\/24383\/revisions\/24385"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/idibell.cat\/wp-json\/wp\/v2\/media\/24384"}],"wp:attachment":[{"href":"https:\/\/idibell.cat\/wp-json\/wp\/v2\/media?parent=24383"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/idibell.cat\/wp-json\/wp\/v2\/categories?post=24383"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/idibell.cat\/wp-json\/wp\/v2\/tags?post=24383"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}