{"id":21891,"date":"2026-10-22T14:39:54","date_gmt":"2026-10-22T14:39:54","guid":{"rendered":"https:\/\/veilles-affaires-sociales.fr\/?p=21891"},"modified":"2026-10-22T14:39:54","modified_gmt":"2026-10-22T14:39:54","slug":"webinaire-a-lintention-des-promoteurs-et-des-autorites-competentes-deux-ans-dexperience-avec-levaluation-coordonnee-pilote-des-investigations-cliniques-et-des-perf","status":"publish","type":"post","link":"https:\/\/veilles-affaires-sociales.fr\/?p=21891","title":{"rendered":"Webinaire \u00e0 l\u2019intention des promoteurs et des autorit\u00e9s comp\u00e9tentes \u2013 Deux ans d\u2019exp\u00e9rience avec l\u2019\u00e9valuation coordonn\u00e9e pilote des investigations cliniques et des performances (CI\/PS) dans le cadre du MDR et de l\u2019IVDR (6 novembre 2026, 14h00-15h30)\u00a0(titre traduit en fran\u00e7ais par l&rsquo;IA)"},"content":{"rendered":"<p>Un webinaire en ligne en anglais, organis\u00e9 via Webex, est pr\u00e9vu le 6 novembre 2026 de 14h00 \u00e0 15h30 (CET) pour pr\u00e9senter le dispositif pilote d\u2019\u00e9valuation coordonn\u00e9e des investigations cliniques et des \u00e9tudes de performance portant sur les dispositifs m\u00e9dicaux. Il s\u2019adresse principalement aux promoteurs potentiels et \u00e0 d\u2019autres parties prenantes int\u00e9ress\u00e9es par ce dispositif.<\/p>\n<p>Les intervenants seront des repr\u00e9sentants de fabricants de dispositifs m\u00e9dicaux ayant d\u00e9j\u00e0 men\u00e9 des \u00e9valuations dans le cadre de ce projet pilote, ainsi que des repr\u00e9sentants des autorit\u00e9s comp\u00e9tentes et de la Commission europ\u00e9enne. Les autorit\u00e9s comp\u00e9tentes et la Commission europ\u00e9enne y jouent un r\u00f4le de pilotage et de retour d\u2019exp\u00e9rience sur la mise en \u0153uvre de l\u2019\u00e9valuation coordonn\u00e9e, tandis que les fabricants pr\u00e9sentent leur exp\u00e9rience pratique du dispositif.<\/p>\n<p>L\u2019enjeu principal, pour les politiques de sant\u00e9 et de r\u00e9gulation des dispositifs m\u00e9dicaux, concerne l\u2019organisation et le fonctionnement de cette \u00e9valuation coordonn\u00e9e au niveau europ\u00e9en, susceptible d\u2019avoir un impact sur les proc\u00e9dures nationales d\u2019autorisation et de suivi des investigations cliniques. L\u2019\u00e9v\u00e9nement peut fournir des \u00e9l\u00e9ments utiles de comparaison internationale pour l\u2019administration fran\u00e7aise quant aux pratiques d\u2019\u00e9valuation, aux interactions entre autorit\u00e9s et industriels, ainsi qu\u2019aux modalit\u00e9s de coordination entre \u00c9tats membres, m\u00eame si le contenu d\u00e9taill\u00e9 des retours d\u2019exp\u00e9rience et des d\u00e9cisions attendues n\u2019est pas pr\u00e9cis\u00e9 dans l\u2019annonce.  (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l&rsquo;IA) \u00a0\u200b<a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/webinar-sponsors-and-competent-authorities-two-years-experience-pilot-coordinated-assessment-cips-2026-10-22_en\" target=\"_blank\" class=\"feedzy-rss-link-icon\">Lire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Un webinaire en ligne en anglais, organis\u00e9 via Webex, est pr\u00e9vu le 6 novembre 2026 de 14h00 \u00e0 15h30 (CET) pour pr\u00e9senter le dispositif pilote d\u2019\u00e9valuation coordonn\u00e9e des investigations cliniques [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":17753,"comment_status":"","ping_status":"","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":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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