{"id":2225,"date":"2017-07-26T14:15:00","date_gmt":"2017-07-26T14:15:00","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/2017\/07\/26\/new-ich-e19-guideline-development-optimisation-safety-data-collection\/"},"modified":"2017-07-26T14:15:00","modified_gmt":"2017-07-26T14:15:00","slug":"new-ich-e19-guideline-development-optimisation-safety-data-collection","status":"publish","type":"post","link":"https:\/\/dev.ich.org\/index.php\/2017\/07\/26\/new-ich-e19-guideline-development-optimisation-safety-data-collection\/","title":{"rendered":"New ICH E19 Guideline in Development on Optimisation of Safety Data Collection"},"content":{"rendered":"<p>In November 2016, the ICH endorsed a new topic on Optimisation of safety data collection. This guideline will provide a harmonised guidance on when it would be appropriate to use a targeted approach to safety data collection in some late-stage pre-marketing or post-marketing studies, and how such an approach would be implemented.<\/p>\n<p>The E19 <a href=\"https:\/\/admin.ich.org\/sites\/default\/files\/inline-files\/E19_EWG_Concept_Paper_27Jun2017.pdf\">Concept Paper<\/a> and <a href=\"https:\/\/admin.ich.org\/sites\/default\/files\/inline-files\/E19_EWG_Business_Plan_27Jun2017.pdf\">Business Plan<\/a> are now available for download on the ICH website under the <a href=\"https:\/\/www.ich.org\/page\/efficacy-guidelines\">Efficacy<\/a> section of the ICH website.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>In November 2016, the ICH endorsed a new topic on Optimisation of safety data collection. This guideline will provide harmonised guidance on when a targeted approach to safety data collection would be appropriate.<\/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-2225","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\/2225","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=2225"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts\/2225\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=2225"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/categories?post=2225"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/tags?post=2225"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}