{"id":2258,"date":"2016-07-14T18:15:00","date_gmt":"2016-07-14T18:15:00","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/2016\/07\/14\/ich-m4er2-guideline-reaches-step-4-ich-process\/"},"modified":"2016-07-14T18:15:00","modified_gmt":"2016-07-14T18:15:00","slug":"ich-m4er2-guideline-reaches-step-4-ich-process","status":"publish","type":"post","link":"https:\/\/dev.ich.org\/index.php\/2016\/07\/14\/ich-m4er2-guideline-reaches-step-4-ich-process\/","title":{"rendered":"ICH M4E(R2) Guideline Reaches Step 4 of the ICH Process"},"content":{"rendered":"<p>The revised version of the ICH M4E(R1) Guideline on Enhancing the Format and Structure of Benefit-Risk Information in ICH reached Step 4 of the ICH Process in June 2016 and now enters the implementation period (Step 5).<\/p>\n<p>The <a href=\"https:\/\/admin.ich.org\/sites\/default\/files\/inline-files\/M4E_R2__Step_4.pdf\">M4E(R2) Guideline<\/a> includes greater specificity on the format and structure of benefit-risk information, harmonising the presentation of this information in regulatory submissions.<\/p>\n<p>The M4E(R2) is available for download under the <a href=\"https:\/\/www.ich.org\/page\/multidisciplinary-guidelines\">Multidisciplinary\/CTD Guideline<\/a> page on the ICH website.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The revised version of the ICH M4E(R1) Guideline on Enhancing the Format and Structure of Benefit-Risk Information in ICH reached Step 4 of the ICH Process in June 2016 and now enters the implementation period (Step 5).<\/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-2258","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\/2258","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=2258"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts\/2258\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=2258"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/categories?post=2258"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/tags?post=2258"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}