{"id":2305,"date":"2014-04-11T19:15:00","date_gmt":"2014-04-11T19:15:00","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/2014\/04\/11\/ich-e2cr2-qas-available-ich-website\/"},"modified":"2014-04-11T19:15:00","modified_gmt":"2014-04-11T19:15:00","slug":"ich-e2cr2-qas-available-ich-website","status":"publish","type":"post","link":"https:\/\/dev.ich.org\/index.php\/2014\/04\/11\/ich-e2cr2-qas-available-ich-website\/","title":{"rendered":"ICH E2C(R2) Q&#038;As Available on the ICH Website"},"content":{"rendered":"<p>In March 2014, the ICH E2C(R2) Implementation Working Group finalised under Step 4 of the ICH Process a set of Questions and Answers addressing new concepts and principles linked to an evolution of the traditional PSUR from an interval safety report to cumulative benefit-risk report and with a change in focus from individual case reports to more aggregate data evaluation.<\/p>\n<p>This supplementary Questions and Answers document intends to clarify key issues which were identified since the ICH E2C(R2) Guideline was published in the three ICH Regions.<\/p>\n<p>The ICH E2C(R2) Q&amp;As document is available for download from the E2C Section on the <a href=\"https:\/\/www.ich.org\/page\/efficacy-guidelines\">Efficacy Guideline<\/a> page.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>In March 2014, the ICH E2C(R2) Implementation Working Group finalised under Step 4 of the ICH Process a set of Questions and Answers addressing new concepts and principles linked to an evolution of the traditional PSUR.<\/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-2305","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\/2305","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=2305"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts\/2305\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=2305"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/categories?post=2305"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/tags?post=2305"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}