{"id":7950,"date":"2025-01-08T20:33:04","date_gmt":"2025-01-08T12:33:04","guid":{"rendered":"https:\/\/regask.com\/?p=7950"},"modified":"2025-01-08T20:33:04","modified_gmt":"2025-01-08T12:33:04","slug":"reunion-de-la-fda-sur-les-medicaments-pediatriques-aux-etats-unis","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/us-fda-pediatric-drug-meeting\/","title":{"rendered":"La FDA am\u00e9ricaine annonce une r\u00e9union publique sur la l\u00e9gislation p\u00e9diatrique\u2026"},"content":{"rendered":"<p>Le <strong><a href=\"https:\/\/regask.com\/fr\/developpement-de-medicaments-centre-sur-le-patient-par-la-fda\/\">Administration des aliments et des m\u00e9dicaments<\/a> (FDA)<\/strong> a programm\u00e9 une r\u00e9union publique intitul\u00e9e <strong>\u00ab R\u00e9union des parties int\u00e9ress\u00e9es : mise en \u0153uvre de la loi sur les meilleurs produits pharmaceutiques pour les enfants (BPCA) et de la loi sur l\u2019\u00e9quit\u00e9 en recherche p\u00e9diatrique (PREA) \u00bb<\/strong> sur <strong>15 mai 2025<\/strong>Cet \u00e9v\u00e9nement offrira une plateforme aux parties prenantes pour discuter de l\u2019impact de la l\u00e9gislation p\u00e9diatrique sur le d\u00e9veloppement de m\u00e9dicaments et de produits biologiques, fa\u00e7onnant ainsi les avanc\u00e9es futures dans les soins de sant\u00e9 p\u00e9diatriques.<\/p>\n<h4><strong>Objectifs de la r\u00e9union :<\/strong><\/h4>\n<p>La FDA sollicite l\u2019avis de diverses parties prenantes, notamment des groupes de patients, des soignants, des repr\u00e9sentants de l\u2019industrie et du monde universitaire, pour :<\/p>\n<ol>\n<li><strong>\u00c9valuer l\u2019impact sur la sant\u00e9 publique :<\/strong> Examiner comment le BPCA et le PREA ont influenc\u00e9 les options de traitement p\u00e9diatrique et r\u00e9pondu aux besoins m\u00e9dicaux non satisfaits.<\/li>\n<li><strong>Incitations et exigences en mati\u00e8re d\u2019\u00e9quilibre :<\/strong> D\u00e9couvrez comment les incitations pr\u00e9vues par le BPCA et les mandats d\u2019\u00e9tude pr\u00e9vus par le PREA affectent les plans de d\u00e9veloppement de m\u00e9dicaments.<\/li>\n<li><strong>Identifier les obstacles :<\/strong> Discutez des d\u00e9fis tels que l\u2019infrastructure des essais cliniques, la diversit\u00e9 des inscriptions et les obstacles emp\u00eachant l\u2019ach\u00e8vement de l\u2019\u00e9tude.<\/li>\n<li><strong>Tirer parti des avanc\u00e9es scientifiques :<\/strong> Mettre en \u00e9vidence des approches innovantes telles que l\u2019extrapolation p\u00e9diatrique, les conceptions d\u2019essais adaptatives, les biomarqueurs comme substituts et les donn\u00e9es du monde r\u00e9el pour am\u00e9liorer la production de preuves pour les populations p\u00e9diatriques.<\/li>\n<li><strong>Am\u00e9liorer l\u2019alignement global :<\/strong> Aborder l\u2019importance de la collaboration internationale dans le d\u00e9veloppement de m\u00e9dicaments p\u00e9diatriques.<\/li>\n<\/ol>\n<h4><strong>D\u00e9tails de l&#039;\u00e9v\u00e9nement :<\/strong><\/h4>\n<ul>\n<li><strong>Date:<\/strong> 15 mai 2025<\/li>\n<li><strong>Temps:<\/strong> 9h00 \u2013 16h30, heure de l\u2019Est<\/li>\n<li><strong>Emplacement:<\/strong>\n<ul>\n<li><strong>Pratiquement<\/strong><\/li>\n<li><strong>Sur place :<\/strong> Campus de la FDA \u00e0 White Oak, 10903 New Hampshire Ave., b\u00e2timent 31, centre de conf\u00e9rence, la grande salle White Oak, Silver Spring, MD 20993-0002<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h4><strong>Comment participer :<\/strong><\/h4>\n<ul>\n<li>Les parties prenantes sont encourag\u00e9es \u00e0 assister \u00e0 la r\u00e9union et \u00e0 partager leurs exp\u00e9riences li\u00e9es au BPCA et au PREA.<\/li>\n<li>Les commentaires \u00e9lectroniques ou \u00e9crits sur la r\u00e9union doivent \u00eatre soumis par <strong>13 juin 2025<\/strong>.<\/li>\n<\/ul>\n<h4><strong>Impact sur le d\u00e9veloppement de m\u00e9dicaments p\u00e9diatriques :<\/strong><\/h4>\n<p>Cette r\u00e9union publique aura pour objectif d&#039;influencer les strat\u00e9gies de d\u00e9veloppement de m\u00e9dicaments et de produits biologiques p\u00e9diatriques, en mettant l&#039;accent sur les domaines o\u00f9 les besoins m\u00e9dicaux non satisfaits sont importants. L&#039;accent mis par la FDA sur l&#039;exploitation de m\u00e9thodologies scientifiques avanc\u00e9es telles que les donn\u00e9es du monde r\u00e9el, les essais adaptatifs et l&#039;extrapolation p\u00e9diatrique offre aux parties prenantes l&#039;occasion d&#039;aligner leurs plans de d\u00e9veloppement sur l&#039;\u00e9volution des attentes r\u00e9glementaires.<\/p>\n<p>Cette r\u00e9union refl\u00e8te la <a href=\"https:\/\/regask.com\/fr\/approbation-des-dispositifs-medicaux-par-la-fda-interface-de-type-iron-man\/\">L&#039;engagement de la FDA<\/a> pour faire progresser les soins de sant\u00e9 p\u00e9diatriques gr\u00e2ce \u00e0 la collaboration, \u00e0 l\u2019innovation et \u00e0 des cadres r\u00e9glementaires solides.<\/p>","protected":false},"excerpt":{"rendered":"<p>The Food and Drug Administration (FDA) has scheduled a public meeting titled \u201cInterested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act (BPCA) and Paediatric Research Equity Act (PREA)\u201d on May 15, 2025. This event will provide a platform for stakeholders to discuss the impact of paediatric legislation on drug and biologic development, shaping&#8230;<\/p>","protected":false},"author":43,"featured_media":7955,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,35],"tags":[165,617],"class_list":["post-7950","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-united-states-regulations","category-pharma-biotech-latest-insights","tag-public-health","tag-biologics-regulation"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>US FDA to Host Meeting on Pediatric Drug Development | RegASK<\/title>\n<meta name=\"description\" content=\"US FDA announces a public meeting on pediatric drug development, focusing on BPCA, &amp; PREA. 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