{"id":4281,"date":"2023-05-25T08:29:06","date_gmt":"2023-05-25T00:29:06","guid":{"rendered":"https:\/\/regask.com\/?p=4281"},"modified":"2024-10-26T02:58:11","modified_gmt":"2024-10-25T18:58:11","slug":"document-dassurance-qualite-des-essais-cliniques-en-italie","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/italy-clinical-trials-qa-document\/","title":{"rendered":"L&#039;Italie publie des nouvelles concernant un document de questions-r\u00e9ponses sur Clin\u2026"},"content":{"rendered":"<div>\n<div>Le <a href=\"https:\/\/www.aifa.gov.it\/en\/\" target=\"_blank\" rel=\"noopener\">Agence italienne des m\u00e9dicaments (AIFA)<\/a> Des informations ont r\u00e9cemment \u00e9t\u00e9 publi\u00e9es concernant un nouveau document \u00ab\u00a0Questions et r\u00e9ponses version 1.0\u00a0\u00bb. Ce document vise \u00e0 faciliter la mise en \u0153uvre de la nouvelle r\u00e9glementation sur les essais cliniques.<\/div>\n<div><\/div>\n<div>Ce document rassemble les questions et r\u00e9ponses d\u00e9j\u00e0 publi\u00e9es sur le site institutionnel de l&#039;AIFA, les regroupant par type, avec des mises \u00e0 jour et l&#039;ajout de nouvelles questions. Il sera progressivement mis \u00e0 jour par l&#039;AIFA. Les questions et r\u00e9ponses sont sp\u00e9cifiques \u00e0 l&#039;Italie et concernent des questions qui ne figurent pas d\u00e9j\u00e0 dans les documents publi\u00e9s par la Commission europ\u00e9enne.<\/div>\n<div><\/div>\n<\/div>\n<ul>\n<li><strong>En savoir plus sur la mani\u00e8re dont le guide DCT RegASK peut vous aider\u00a0:\u00a0<\/strong><strong><a href=\"https:\/\/regask.com\/fr\/regulatory-guidebooks-paved-the-way-for-decentralized-clinical-trials\/\" target=\"_blank\" rel=\"noopener\">Les guides r\u00e9glementaires ont ouvert la voie aux essais cliniques d\u00e9centralis\u00e9s<\/a><\/strong><\/li>\n<li>Besoin d&#039;en savoir plus sur les changements r\u00e9glementaires DCT ? <a href=\"https:\/\/regask.com\/fr\/contact-2\/\" target=\"_blank\" rel=\"noopener\">Contactez les experts de RegASK.<\/a><\/li>\n<\/ul>\n<div><\/div>\n<a href=\"https:\/\/regask.com\/fr\/contact-2\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Contactez RegASK pour plus de d\u00e9tails<\/span>\n\t<\/a>\n\n<a href=\"https:\/\/regask.com\/fr\/categorie\/dernieres-informations\/medical-devices-latest-insights\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>En savoir plus<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-914346209\">\n\n\t<div id=\"col-62022444\" 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\/fr\/etudes-de-cas\/ressources-etudes-de-cas-dispositifs-medicaux\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lire les \u00e9tudes de cas sur le secteur des dispositifs m\u00e9dicaux<\/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>The Italian Medicines Agency (AIFA) recently published news regarding a new document &#8216;Questions &amp; Answers Version 1.0&#8217;. In order to facilitate the implementation of new Clinical Trial Regulations. This document collects the Questions &amp; Answers already published on the AIFA institutional website, grouping them by type, with updates and the addition of new Q&amp;As. The&#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-4281","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 v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Italy Simplifies Clinical Trials with New QA Document | RegASK<\/title>\n<meta name=\"description\" content=\"Italy publishes a QA document to facilitate the implementation of new clinical trial regulations. 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\/fr\/document-dassurance-qualite-des-essais-cliniques-en-italie\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Italy Publishes News Regarding Q&amp;A Document on Clinical Trials Facilitating Implementation of New Regulation\" \/>\n<meta property=\"og:description\" content=\"Italy publishes a QA document to facilitate the implementation of new clinical trial regulations. Stay informed with RegASK.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/fr\/document-dassurance-qualite-des-essais-cliniques-en-italie\/\" \/>\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=\"2023-05-25T00:29:06+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-10-25T18:58:11+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 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/italy-clinical-trials-qa-document\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/italy-clinical-trials-qa-document\\\/\"},\"author\":{\"name\":\"Benoit Trouwaert\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\"},\"headline\":\"Italy Publishes News Regarding Q&amp;A Document on Clin&hellip;\",\"datePublished\":\"2023-05-25T00:29:06+00:00\",\"dateModified\":\"2024-10-25T18:58:11+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/italy-clinical-trials-qa-document\\\/\"},\"wordCount\":201,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/italy-clinical-trials-qa-document\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/09\\\/Therapeutic-goods-medical-devices.png\",\"keywords\":[\"Latest Insights\"],\"articleSection\":[\"Italy\",\"Medical Devices\"],\"inLanguage\":\"fr-FR\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/italy-clinical-trials-qa-document\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/italy-clinical-trials-qa-document\\\/\",\"name\":\"Italy Simplifies Clinical Trials with New QA Document | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/italy-clinical-trials-qa-document\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/italy-clinical-trials-qa-document\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/09\\\/Therapeutic-goods-medical-devices.png\",\"datePublished\":\"2023-05-25T00:29:06+00:00\",\"dateModified\":\"2024-10-25T18:58:11+00:00\",\"description\":\"Italy publishes a QA document to facilitate the implementation of new clinical trial regulations. 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