{"id":2326,"date":"2012-12-20T21:45:00","date_gmt":"2012-12-20T21:45:00","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/2012\/12\/20\/ich-e2cr2-guideline-reaches-step-4-ich-process\/"},"modified":"2012-12-20T21:45:00","modified_gmt":"2012-12-20T21:45:00","slug":"ich-e2cr2-guideline-reaches-step-4-ich-process","status":"publish","type":"post","link":"https:\/\/dev.ich.org\/index.php\/2012\/12\/20\/ich-e2cr2-guideline-reaches-step-4-ich-process\/","title":{"rendered":"ICH E2C(R2) Guideline Reaches Step 4 of the ICH Process"},"content":{"rendered":"<p>The ICH E2C(R2) Guideline on Periodic Benefit-Risk Evaluation Report reached <em>Step 4<\/em> of the ICH Process in November 2012 and now enters the implementation period (<em>Step 5<\/em>).<\/p>\n<p>The purpose of this revised guidance is to ensure that the periodic safety update reports for marketed drugs have the role of being periodic benefit-risk evaluation reports by covering: Safety evaluation, evaluation of all relevant available information accessible to marketing authorisation holders (MAHs) and benefit-risk evaluation.<\/p>\n<p>The final Guideline is now available for download under the <a href=\"https:\/\/www.ich.org\/page\/efficacy-guidelines\">Efficacy Guideline page<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The ICH E2C(R2) Guideline on Periodic Benefit-Risk Evaluation Report reached Step 4 of the ICH Process in November 2012 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-2326","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\/2326","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=2326"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts\/2326\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=2326"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/categories?post=2326"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/tags?post=2326"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}