{"id":91313,"date":"2023-10-20T14:15:32","date_gmt":"2023-10-20T18:15:32","guid":{"rendered":"https:\/\/wfh.org\/article\/le-rtg-de-la-fmh-recoit-un-soutien-majeur-de-la-part-du-chmp-de-lema\/"},"modified":"2024-04-04T15:49:31","modified_gmt":"2024-04-04T19:49:31","slug":"le-rtg-de-la-fmh-recoit-un-soutien-majeur-de-la-part-du-chmp-de-lema","status":"publish","type":"post","link":"https:\/\/wfh.org\/fr\/article\/le-rtg-de-la-fmh-recoit-un-soutien-majeur-de-la-part-du-chmp-de-lema\/","title":{"rendered":"Le RTG de la FMH re\u00e7oit un soutien majeur de la part du CHMP de l\u2019EMA"},"content":{"rendered":"\t\t
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\u00ab Le CHMP soutient le Registre de th\u00e9rapie g\u00e9nique (RTG) de la FMH en tant que registre mondial pour la consolidation des donn\u00e9es internationales sur les personnes atteintes d\u2019h\u00e9mophilie qui re\u00e7oivent une th\u00e9rapie g\u00e9nique. Le Comit\u00e9 encourage la collaboration des centres de traitement de l\u2019h\u00e9mophilie et des registres nationaux du monde entier avec le RTG. \u00bb <\/h2>\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
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Le CHMP souligne l\u2019int\u00e9r\u00eat particulier de l\u2019utilisation du RTG de la FMH dans les \u00e9tudes post-approbation sur la s\u00e9curit\u00e9 ou l\u2019efficacit\u00e9 des th\u00e9rapies g\u00e9niques. Le comit\u00e9 recommande par cons\u00e9quent son utilisation comme source de donn\u00e9es planifi\u00e9e dans les \u00e9tudes mandat\u00e9es de phase IV pour les nouveaux traitements de l\u2019h\u00e9mophilie. Cette approbation majeure montre bien la valeur du RTG dans l\u2019harmonisation de donn\u00e9es mondiales et standardis\u00e9es sur les personnes atteintes d\u2019h\u00e9mophilie qui re\u00e7oivent une th\u00e9rapie g\u00e9nique.<\/p>\n

Le processus de qualification de l\u2019EMA se fait sur la base du volontariat et selon des crit\u00e8res scientifiques\u00a0; il est con\u00e7u pour \u00e9valuer et approuver de nouvelles m\u00e9thodes et de nouveaux outils pour le d\u00e9veloppement et l\u2019\u00e9valuation des m\u00e9dicaments au sein de l\u2019Union europ\u00e9enne (UE). Cette proc\u00e9dure vise \u00e0 valider des techniques et technologies innovantes, afin d\u2019am\u00e9liorer l\u2019\u00e9valuation et le d\u00e9veloppement des traitements m\u00e9dicaux.<\/p>\n

La FMH avait commenc\u00e9 le processus de qualification du RTG en ao\u00fbt 2022. Apr\u00e8s des discussions approfondies entre la FMH et l\u2019EMA sur tous les aspects, y compris le jeu principal de donn\u00e9es, la gestion des donn\u00e9es et la surveillance des donn\u00e9es de s\u00e9curit\u00e9, la proc\u00e9dure d\u2019inscription, la gouvernance et les strat\u00e9gies d\u2019engagement des diverses parties prenantes, le CHMP a publi\u00e9 une lettre de soutien, appelant tous les pays \u00e0 participer au RTG, que ce soit par le biais de la participation de centres de traitements de l\u2019h\u00e9mophilie (CTH) individuels ou bien du transfert de donn\u00e9es depuis des registres nationaux d\u00e9j\u00e0 existants.<\/p>\n

Une fois que sa capacit\u00e9 \u00e0 collecter des donn\u00e9es et \u00e0 g\u00e9n\u00e9rer des rapports dans le cadre d\u2019\u00e9tudes aura \u00e9t\u00e9 \u00e9tablie, la FMH soumettra le RTG pour \u00e9valuation en vue d\u2019obtenir sa qualification compl\u00e8te, ce qui constituera un tournant majeur dans l\u2019am\u00e9lioration du traitement de l\u2019h\u00e9mophilie et des soins aux patient\u00b7es.<\/p>\n

Pour lire l\u2019int\u00e9gralit\u00e9 de la lettre publi\u00e9e par le CHMP de l\u2019EMA, cliquez ici<\/a>. Pour en savoir plus sur le Registre de la th\u00e9rapie g\u00e9nique (RTG), cliquez ici<\/a>.<\/p>\n\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>\n\t\t","protected":false},"excerpt":{"rendered":"

Le Registre de la th\u00e9rapie g\u00e9nique (GTR) de la F\u00e9d\u00e9ration mondiale de l\u2019h\u00e9mophilie (FMH) est un registre prospectif, observationnel et longitudinal con\u00e7u pour recueillir des donn\u00e9es \u00e0 long terme sur les personnes atteintes d\u2019h\u00e9mophilie qui b\u00e9n\u00e9ficient de la th\u00e9rapie g\u00e9nique. Son objectif principal est de d\u00e9terminer la s\u00e9curit\u00e9 \u00e0 long terme des th\u00e9rapies g\u00e9niques du facteur\u202fVIII et du facteur\u202fIX pour les personnes atteintes d\u2019h\u00e9mophilie. Le 16 octobre 2023, le comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) a publi\u00e9 une lettre de soutien essentielle en faveur de l\u2019adoption du RTG de la FMH dans le monde entier :<\/p>\n","protected":false},"author":13,"featured_media":73022,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[177],"tags":[],"search-category":[85],"class_list":["post-91313","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actualite-medicale","search-category-article"],"yoast_head":"\nLe RTG de la FMH re\u00e7oit un soutien majeur de la part du CHMP de l\u2019EMA | FMH - F\u00e9d\u00e9ration mondiale de l\u2019h\u00e9mophilie<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/wfh.org\/fr\/article\/le-rtg-de-la-fmh-recoit-un-soutien-majeur-de-la-part-du-chmp-de-lema\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Le RTG de la FMH re\u00e7oit un soutien majeur de la part du CHMP de l\u2019EMA\" \/>\n<meta property=\"og:description\" content=\"Le Registre de la th\u00e9rapie g\u00e9nique (GTR) de la F\u00e9d\u00e9ration mondiale de l\u2019h\u00e9mophilie (FMH) est un registre prospectif, observationnel et longitudinal con\u00e7u pour recueillir des donn\u00e9es \u00e0 long terme sur les personnes atteintes d\u2019h\u00e9mophilie qui b\u00e9n\u00e9ficient de la th\u00e9rapie g\u00e9nique. Son objectif principal est de d\u00e9terminer la s\u00e9curit\u00e9 \u00e0 long terme des th\u00e9rapies g\u00e9niques du facteur\u202fVIII et du facteur\u202fIX pour les personnes atteintes d\u2019h\u00e9mophilie. Le 16 octobre 2023, le comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) a publi\u00e9 une lettre de soutien essentielle en faveur de l\u2019adoption du RTG de la FMH dans le monde entier :\" \/>\n<meta property=\"og:url\" content=\"https:\/\/wfh.org\/fr\/article\/le-rtg-de-la-fmh-recoit-un-soutien-majeur-de-la-part-du-chmp-de-lema\/\" \/>\n<meta property=\"og:site_name\" content=\"FMH - F\u00e9d\u00e9ration mondiale de l\u2019h\u00e9mophilie\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/wfhemophilia\/\" \/>\n<meta property=\"article:published_time\" content=\"2023-10-20T18:15:32+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-04-04T19:49:31+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/wfh.org\/wp-content\/uploads\/2023\/06\/Stock-digital-map-world.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\n\t<meta property=\"og:image:height\" content=\"627\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Mitch Semienchuk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\u00c9crit par\" \/>\n\t<meta name=\"twitter:data1\" content=\"Mitch Semienchuk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/wfh.org\/fr\/article\/le-rtg-de-la-fmh-recoit-un-soutien-majeur-de-la-part-du-chmp-de-lema\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/wfh.org\/fr\/article\/le-rtg-de-la-fmh-recoit-un-soutien-majeur-de-la-part-du-chmp-de-lema\/\"},\"author\":{\"name\":\"Mitch Semienchuk\",\"@id\":\"https:\/\/wfh.org\/fr\/#\/schema\/person\/4aea5b13c1966452a640eef39423925b\"},\"headline\":\"Le RTG de la FMH re\u00e7oit un soutien majeur de la part du CHMP de l\u2019EMA\",\"datePublished\":\"2023-10-20T18:15:32+00:00\",\"dateModified\":\"2024-04-04T19:49:31+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/wfh.org\/fr\/article\/le-rtg-de-la-fmh-recoit-un-soutien-majeur-de-la-part-du-chmp-de-lema\/\"},\"wordCount\":466,\"publisher\":{\"@id\":\"https:\/\/wfh.org\/fr\/#organization\"},\"image\":{\"@id\":\"https:\/\/wfh.org\/fr\/article\/le-rtg-de-la-fmh-recoit-un-soutien-majeur-de-la-part-du-chmp-de-lema\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/wfh.org\/wp-content\/uploads\/2023\/06\/Stock-digital-map-world.jpg\",\"articleSection\":[\"Actualit\u00e9 m\u00e9dicale\"],\"inLanguage\":\"fr-FR\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/wfh.org\/fr\/article\/le-rtg-de-la-fmh-recoit-un-soutien-majeur-de-la-part-du-chmp-de-lema\/\",\"url\":\"https:\/\/wfh.org\/fr\/article\/le-rtg-de-la-fmh-recoit-un-soutien-majeur-de-la-part-du-chmp-de-lema\/\",\"name\":\"Le RTG de la FMH re\u00e7oit un soutien majeur de la part du CHMP de l\u2019EMA | FMH - 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