{"id":4324,"date":"2023-07-20T09:25:17","date_gmt":"2023-07-20T01:25:17","guid":{"rendered":"https:\/\/regask.com\/?p=4324"},"modified":"2024-11-22T04:48:00","modified_gmt":"2024-11-21T20:48:00","slug":"updates-zur-ethik-von-medizinprodukten-in-italien","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/italy-medical-device-ethics-updates\/","title":{"rendered":"Klinische Pr\u00fcfungen von Medizinprodukten \u2013 Aktualisierungen Rega\u2026"},"content":{"rendered":"<div>\n<div>\n<div>In Italien hat es zahlreiche \u00c4nderungen im Rahmen klinischer Studien gegeben, darunter vier neue Verordnungen zu klinischen Studien mit Medizinprodukten und Arzneimitteln f\u00fcr den menschlichen Gebrauch.<\/div>\n<div><\/div>\n<div>Das Ministerium ver\u00f6ffentlichte am 28. Februar 2023 ein Rundschreiben, in dem die Anwendung der Verordnungen und die Auswirkungen der neuen Regelung dargelegt wurden. Insbesondere wurden die Auswirkungen der durch das Dekret des Gesundheitsministers vom 30. Januar 2023 festgelegten Regeln zur Festlegung der Kriterien f\u00fcr die Zusammensetzung und Arbeitsweise der territorialen Ethikkommissionen sowie des Dekrets des Gesundheitsministers vom 26. Januar 2023 zur Einrichtung von 40 territorialen Ethikkommissionen erl\u00e4utert.<\/div>\n<div><\/div>\n<\/div>\n<\/div>\n<ul>\n<li><strong>Lesen Sie mehr dar\u00fcber, wie das RegASK DCT-Handbuch helfen kann:\u00a0<\/strong><strong><a href=\"https:\/\/regask.com\/de\/regulatory-guidebooks-paved-the-way-for-decentralized-clinical-trials\/\" target=\"_blank\" rel=\"noopener\">Regulatorische Leitf\u00e4den ebneten den Weg f\u00fcr dezentrale klinische Studien<\/a><\/strong><\/li>\n<li>M\u00f6chten Sie mehr \u00fcber \u00c4nderungen der DCT-Regelung erfahren? <a href=\"https:\/\/regask.com\/de\/kontakt\/\" target=\"_blank\" rel=\"noopener\">Nehmen Sie Kontakt mit den Experten von RegASK auf.<\/a><\/li>\n<\/ul>\n<div><\/div>\n<a href=\"https:\/\/regask.com\/de\/kontakt\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Kontaktieren Sie RegASK f\u00fcr weitere Details<\/span>\n\t<\/a>\n\n<a href=\"https:\/\/regask.com\/de\/kategorie\/neuesten-erkenntnisse\/medical-devices-latest-insights\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Mehr lesen<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-1337075557\">\n\n\t<div id=\"col-1592115063\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/regask.com\/de\/fallstudien\/ressourcen-fallstudien-medizinprodukte\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lesen Sie Fallstudien aus der Medizinger\u00e4tebranche<\/span>\n\t<\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>There have been so many changes in the clinical trial framework in Italy including four new decrees concerning clinical trials on medical devices and medicines for human use. The Ministry released a Circular on February 28, 2023, outlining the ways in which the decrees should be applied and the effects of the new rule. Particularly,&#8230;<\/p>","protected":false},"author":39,"featured_media":2976,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[518,39],"tags":[40],"class_list":["post-4324","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-italy-regulations","category-medical-devices-insights","tag-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Italy Updates Ethics Committees for Medical Device Trials | RegASK<\/title>\n<meta name=\"description\" content=\"The Italian Ministry of Health has released new guidelines for ethics committees in medical device clinical trials. Stay informed with RegASK.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/de\/updates-zur-ethik-von-medizinprodukten-in-italien\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Clinical trials of Medical Devices - Updates Regarding Ethics Committees and its composition by Italian Ministry of Health\" \/>\n<meta property=\"og:description\" content=\"The Italian Ministry of Health has released new guidelines for ethics committees in medical device clinical trials. Stay informed with RegASK.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/de\/updates-zur-ethik-von-medizinprodukten-in-italien\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2023-07-20T01:25:17+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-21T20:48:00+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2021\/09\/Therapeutic-goods-medical-devices.png\" \/>\n\t<meta property=\"og:image:width\" content=\"689\" \/>\n\t<meta property=\"og:image:height\" content=\"626\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Benoit Trouwaert\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Benoit Trouwaert\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1\u00a0Minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/italy-medical-device-ethics-updates\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/italy-medical-device-ethics-updates\\\/\"},\"author\":{\"name\":\"Benoit Trouwaert\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\"},\"headline\":\"Clinical trials of Medical Devices &#8211; Updates Rega&hellip;\",\"datePublished\":\"2023-07-20T01:25:17+00:00\",\"dateModified\":\"2024-11-21T20:48:00+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/italy-medical-device-ethics-updates\\\/\"},\"wordCount\":218,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/italy-medical-device-ethics-updates\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/09\\\/Therapeutic-goods-medical-devices.png\",\"keywords\":[\"Latest Insights\"],\"articleSection\":[\"Italy\",\"Medical Devices\"],\"inLanguage\":\"de\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/italy-medical-device-ethics-updates\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/italy-medical-device-ethics-updates\\\/\",\"name\":\"Italy Updates Ethics Committees for Medical Device Trials | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/italy-medical-device-ethics-updates\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/italy-medical-device-ethics-updates\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/09\\\/Therapeutic-goods-medical-devices.png\",\"datePublished\":\"2023-07-20T01:25:17+00:00\",\"dateModified\":\"2024-11-21T20:48:00+00:00\",\"description\":\"The Italian Ministry of Health has released new guidelines for ethics committees in medical device clinical trials. 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