{"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":"%e3%82%a4%e3%82%bf%e3%83%aa%e3%82%a2%e3%81%ae%e8%87%a8%e5%ba%8a%e8%a9%a6%e9%a8%93qa%e6%96%87%e6%9b%b8","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/italy-clinical-trials-qa-document\/","title":{"rendered":"\u30a4\u30bf\u30ea\u30a2\u3001\u81e8\u5e8a\u691c\u67fb\u306b\u95a2\u3059\u308bQ&amp;A\u6587\u66f8\u306b\u95a2\u3059\u308b\u30cb\u30e5\u30fc\u30b9\u3092\u767a\u8868"},"content":{"rendered":"<div>\n<div>\u306e <a href=\"https:\/\/www.aifa.gov.it\/en\/\" target=\"_blank\" rel=\"noopener\">\u30a4\u30bf\u30ea\u30a2\u533b\u85ac\u54c1\u5e81\uff08AIFA\uff09<\/a> \u6700\u8fd1\u516c\u958b\u3055\u308c\u305f\u65b0\u3057\u3044\u6587\u66f8\u300c\u8cea\u7591\u5fdc\u7b54\u30d0\u30fc\u30b8\u30e7\u30f31.0\u300d\u306b\u95a2\u3059\u308b\u30cb\u30e5\u30fc\u30b9\u3067\u3059\u3002\u65b0\u3057\u3044\u81e8\u5e8a\u8a66\u9a13\u898f\u5247\u306e\u5c0e\u5165\u3092\u5186\u6ed1\u306b\u9032\u3081\u308b\u305f\u3081\u3067\u3059\u3002<\/div>\n<div><\/div>\n<div>\u3053\u306e\u6587\u66f8\u306f\u3001AIFA\u306e\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u306b\u65e2\u306b\u63b2\u8f09\u3055\u308c\u3066\u3044\u308bQ&amp;A\u3092\u7a2e\u985e\u5225\u306b\u307e\u3068\u3081\u3001\u66f4\u65b0\u3068\u65b0\u898fQ&amp;A\u306e\u8ffd\u52a0\u3092\u884c\u3063\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u6587\u66f8\u306fAIFA\u306b\u3088\u3063\u3066\u9806\u6b21\u66f4\u65b0\u3055\u308c\u307e\u3059\u3002\u3053\u308c\u3089\u306eQ&amp;A\u306f\u30a4\u30bf\u30ea\u30a2\u7279\u6709\u306e\u3082\u306e\u3067\u3042\u308a\u3001\u6b27\u5dde\u59d4\u54e1\u4f1a\u304c\u767a\u884c\u3059\u308b\u6587\u66f8\u306b\u306f\u63b2\u8f09\u3055\u308c\u3066\u3044\u306a\u3044\u8cea\u554f\u306b\u95a2\u9023\u3057\u3066\u3044\u307e\u3059\u3002<\/div>\n<div><\/div>\n<\/div>\n<ul>\n<li><strong>RegASK DCT \u30ac\u30a4\u30c9\u30d6\u30c3\u30af\u304c\u3069\u306e\u3088\u3046\u306b\u5f79\u7acb\u3064\u304b\u306b\u3064\u3044\u3066\u306f\u3001\u4ee5\u4e0b\u3092\u3054\u89a7\u304f\u3060\u3055\u3044\u3002\u00a0<\/strong><strong><a href=\"https:\/\/regask.com\/ja\/%e8%a6%8f%e5%88%b6%e3%82%ac%e3%82%a4%e3%83%89%e3%83%96%e3%83%83%e3%82%af%e3%81%8c%e5%88%86%e6%95%a3%e5%9e%8b%e8%87%a8%e5%ba%8a%e8%a9%a6%e9%a8%93%e3%81%b8%e3%81%ae%e9%81%93%e3%82%92%e9%96%8b%e3%81%84\/\" target=\"_blank\" rel=\"noopener\">\u898f\u5236\u30ac\u30a4\u30c9\u30d6\u30c3\u30af\u304c\u5206\u6563\u578b\u81e8\u5e8a\u8a66\u9a13\u3078\u306e\u9053\u3092\u958b\u3044\u305f<\/a><\/strong><\/li>\n<li>DCT \u898f\u5236\u306e\u5909\u66f4\u306b\u3064\u3044\u3066\u3055\u3089\u306b\u8a73\u3057\u304f\u77e5\u308a\u305f\u3044\u3067\u3059\u304b? <a href=\"https:\/\/regask.com\/ja\/%e6%8e%a5%e8%a7%a6\/\" target=\"_blank\" rel=\"noopener\">RegASK \u306e\u5c02\u9580\u5bb6\u306b\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\u3002<\/a><\/li>\n<\/ul>\n<div><\/div>\n<a href=\"https:\/\/regask.com\/ja\/%e6%8e%a5%e8%a7%a6\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>\u8a73\u7d30\u306b\u3064\u3044\u3066\u306fRegASK\u306b\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044<\/span>\n\t<\/a>\n\n<a href=\"https:\/\/regask.com\/ja\/%e3%82%ab%e3%83%86%e3%82%b4%e3%83%aa\/%e6%9c%80%e6%96%b0%e3%81%ae%e6%b4%9e%e5%af%9f\/medical-devices-latest-insights\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>\u7d9a\u304d\u3092\u8aad\u3080<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-1210516595\">\n\n\t<div id=\"col-1409497230\" 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\/ja\/%e3%82%b1%e3%83%bc%e3%82%b9%e3%82%b9%e3%82%bf%e3%83%87%e3%82%a3-2\/%e3%83%aa%e3%82%bd%e3%83%bc%e3%82%b9-%e3%82%b1%e3%83%bc%e3%82%b9%e3%82%b9%e3%82%bf%e3%83%87%e3%82%a3-%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>\u533b\u7642\u6a5f\u5668\u696d\u754c\u306e\u30b1\u30fc\u30b9\u30b9\u30bf\u30c7\u30a3\u3092\u8aad\u3080<\/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 document will be progressively updated by AIFA. The\u00a0 Questions &amp; Answers are specific to Italy and relate to questions that are not already present in the documents published by the European Commission. Read more about how RegASK DCT Guidebook can help:\u00a0Regulatory Guidebooks Paved the Way for Decentralized Clinical Trials Need to know more about DCT&#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\/ja\/\u30a4\u30bf\u30ea\u30a2\u306e\u81e8\u5e8a\u8a66\u9a13qa\u6587\u66f8\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\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\/ja\/\u30a4\u30bf\u30ea\u30a2\u306e\u81e8\u5e8a\u8a66\u9a13qa\u6587\u66f8\/\" \/>\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=\"\u57f7\u7b46\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"Benoit Trouwaert\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593\" \/>\n\t<meta name=\"twitter:data2\" content=\"1\u5206\" \/>\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\":\"ja\"},{\"@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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