{"id":13120,"date":"2022-09-26T11:24:19","date_gmt":"2022-09-26T15:24:19","guid":{"rendered":"https:\/\/3.84.221.207\/?p=13120"},"modified":"2024-02-13T09:04:18","modified_gmt":"2024-02-13T14:04:18","slug":"european-medicines-agency-issues-qualification-opinion-that-enroll-hd-can-provide-data-and-infrastructure-support-for-post-authorization-monitoring-of-medical-products-for-huntingtons-disease","status":"publish","type":"post","link":"https:\/\/www.enroll-hd.org\/fr\/european-medicines-agency-issues-qualification-opinion-that-enroll-hd-can-provide-data-and-infrastructure-support-for-post-authorization-monitoring-of-medical-products-for-huntingtons-disease\/","title":{"rendered":"L'Agence europ\u00e9enne des m\u00e9dicaments \u00e9met un avis de qualification selon lequel Enroll-HD peut fournir un support en mati\u00e8re de donn\u00e9es et d'infrastructures pour la surveillance post-autorisation des produits m\u00e9dicaux contre la maladie de Huntington"},"content":{"rendered":"<style>.elementor-13120 .elementor-element.elementor-element-f2780b1 a{color:var( --e-global-color-primary );}:root{--page-title-display:none;}<\/style>\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"13120\" class=\"elementor elementor-13120\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-f2780b1 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"f2780b1\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-723ba76\" data-id=\"723ba76\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-bfff311 elementor-widget elementor-widget-heading\" data-id=\"bfff311\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">L'Agence europ\u00e9enne des m\u00e9dicaments \u00e9met un avis de qualification selon lequel Enroll-HD peut fournir un support en mati\u00e8re de donn\u00e9es et d'infrastructures pour la surveillance post-autorisation des produits m\u00e9dicaux contre la maladie de Huntington<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f97f91c elementor-widget elementor-widget-text-editor\" data-id=\"f97f91c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>New York, NY, 21 septembre 2022\u00a0; L'Agence europ\u00e9enne des m\u00e9dicaments (EMA) a \u00e9mis un avis de qualification qui d\u00e9taille les facettes du registre Enroll-HD, de l'\u00e9tude observationnelle principale et de la plateforme de recherche clinique qui sont particuli\u00e8rement adapt\u00e9es \u00e0 l'approbation r\u00e9glementaire post-autorisation. Un avis scientifique sur Enroll-HD a \u00e9t\u00e9 demand\u00e9 en mars 2021 dans le cadre d'une initiative r\u00e9cemment lanc\u00e9e par l'EMA visant \u00e0 faciliter l'utilisation des donn\u00e9es provenant de registres bien d\u00e9velopp\u00e9s et complets dans le suivi des produits m\u00e9dicaux apr\u00e8s autorisation. Il est important de noter que l'avis de l'EMA indique que l'\u00e9tude \u00ab Enroll-HD est bien adapt\u00e9e \u00bb et \u00ab peut \u00eatre une source de donn\u00e9es secondaires pour les \u00e9tudes sur l'utilisation des m\u00e9dicaments et les \u00e9tudes de s\u00e9curit\u00e9 et d'efficacit\u00e9 post-autorisation (PASS et PAES) \u00bb ; ces derni\u00e8res \u00e9tudes \u00ab peuvent \u00e9galement \u00eatre imbriqu\u00e9es dans Enroll-HD \u00bb pour fournir des donn\u00e9es primaires.<\/p><p>Enroll-HD a \u00e9t\u00e9 lanc\u00e9 en 2012 par CHDI Foundation, Inc. pour acc\u00e9l\u00e9rer la recherche et le d\u00e9veloppement th\u00e9rapeutique sur la maladie de Huntington et a recrut\u00e9 plus de 28\u00a0000 participants (plus de 21\u00a0000 sont actuellement activement engag\u00e9s) dans plus de 150 sites cliniques dans 23 pays \u00e0 travers le monde. Les participants subissent des \u00e9valuations de base standardis\u00e9es et une collecte d&#039;\u00e9chantillons biologiques lors de leurs visites annuelles, avec des \u00e9valuations \u00e9tendues ou facultatives men\u00e9es \u00e0 la discr\u00e9tion du chercheur principal ou du participant, respectivement.<br \/>\u00ab Cet avis de l'EMA est une tr\u00e8s bonne nouvelle pour le d\u00e9veloppement de m\u00e9dicaments contre la maladie de Huntington, car il acc\u00e9l\u00e9rera la collecte de donn\u00e9es post-autorisation \u00bb, a d\u00e9clar\u00e9 Cristina Sampaio, MD, PhD, directrice clinique de CHDI. \u00ab Cela ajoute consid\u00e9rablement \u00e0 ce vers quoi la communaut\u00e9 enti\u00e8re travaille : une proc\u00e9dure d'approbation des m\u00e9dicaments rigoureuse et rationalis\u00e9e pour la maladie de Huntington. \u00bb<\/p><p>L'avis de l'EMA a soulign\u00e9 des aspects favorables d'Enroll-HD, notamment sa repr\u00e9sentation compl\u00e8te des participants et la collecte de donn\u00e9es sur tout le spectre de la maladie, la r\u00e9tention \u00e9lev\u00e9e des participants, la flexibilit\u00e9 de la plateforme pour s'adapter aux exigences r\u00e9glementaires, le contr\u00f4le syst\u00e9matique de la qualit\u00e9 des donn\u00e9es qui garantit l'int\u00e9grit\u00e9 et la fiabilit\u00e9, et un vaste m\u00e9canisme de partage de donn\u00e9es. <\/p><p>Lisez <a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/scientific-advice-protocol-assistance\/novel-methodologies-biomarkers\/opinions-letters-support-qualification-novel-methodologies-medicine-development#islet-autoantibodies-(aas)-as-enrichment-biomarkers-for-type-1-diabetes-(t1d)-prevention-clinical-trials-section:~:text=medicine%20development%20.-,Use%20of%20Enroll%2DHD%20(a%20Huntington%E2%80%99s%20disease%20patient%20registry)%20as%20a%20data%20source%20and%20infrastructure%20support%20for%20post%2Dauthorisation%20monitoring%20of%20medical%20products,-List%20item\" target=\"_blank\" rel=\"noopener\">l'Avis de qualification de l'EMA<\/a> en entier.<\/p><p>Pour plus d&#039;informations, veuillez contacter Tim McLean (Tim.McLean@Enroll-HD.org) ou Jenny Townhill (Jenny.Townhill@Enroll-HD.org). <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>European Medicines Agency issues qualification opinion that Enroll-HD can provide data and infrastructure support for post-authorization monitoring of medical products for Huntington\u2019s disease New York, NY, September 21, 2022; The European Medicines Agency (EMA) has issued a qualification opinion that details facets of the Enroll-HD registry, core observational study, and clinical research platform that are [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_links_to":"","_links_to_target":""},"categories":[1],"tags":[],"class_list":["post-13120","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/www.enroll-hd.org\/fr\/wp-json\/wp\/v2\/posts\/13120","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.enroll-hd.org\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.enroll-hd.org\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.enroll-hd.org\/fr\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/www.enroll-hd.org\/fr\/wp-json\/wp\/v2\/comments?post=13120"}],"version-history":[{"count":7,"href":"https:\/\/www.enroll-hd.org\/fr\/wp-json\/wp\/v2\/posts\/13120\/revisions"}],"predecessor-version":[{"id":13127,"href":"https:\/\/www.enroll-hd.org\/fr\/wp-json\/wp\/v2\/posts\/13120\/revisions\/13127"}],"wp:attachment":[{"href":"https:\/\/www.enroll-hd.org\/fr\/wp-json\/wp\/v2\/media?parent=13120"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.enroll-hd.org\/fr\/wp-json\/wp\/v2\/categories?post=13120"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.enroll-hd.org\/fr\/wp-json\/wp\/v2\/tags?post=13120"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}