{"id":2054,"date":"2024-05-24T12:00:00","date_gmt":"2024-05-24T12:00:00","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/2024\/05\/24\/ich-m14-draft-guideline-reaches-step-2-ich-process\/"},"modified":"2024-05-24T12:00:00","modified_gmt":"2024-05-24T12:00:00","slug":"ich-m14-draft-guideline-reaches-step-2-ich-process","status":"publish","type":"post","link":"https:\/\/dev.ich.org\/index.php\/2024\/05\/24\/ich-m14-draft-guideline-reaches-step-2-ich-process\/","title":{"rendered":"ICH M14 Draft Guideline Reaches Step 2 of the ICH Process"},"content":{"rendered":"<p>The ICH M14 draft Guideline on \u201cGeneral Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines\u201d has reached <em>Step 2<\/em> of the ICH process on 21 May 2024.<\/p>\n<p>The M14 draft Guideline is available for download on the <a href=\"https:\/\/www.ich.org\/page\/multidisciplinary-guidelines#14-1\">M14 Page<\/a>.<\/p>\n<p>This draft Guideline outlines recommendations and high-level best practices for the conduct of these studies, to streamline the development and regulatory assessment of study protocols and reports. These recommendations and practices also seek to improve the ability of the study protocol and\/or results to be accepted across health authorities and support decision-making in response to study results.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The ICH M14 draft Guideline on \u201cGeneral Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines\u201d has reached Step 2 of the ICH process on 21 May 2024.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[27],"tags":[],"class_list":["post-2054","post","type-post","status-publish","format-standard","hentry","category-news"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts\/2054","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/comments?post=2054"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts\/2054\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=2054"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/categories?post=2054"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/tags?post=2054"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}