{"id":63839,"date":"2016-03-03T23:07:24","date_gmt":"2016-03-04T04:07:24","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=63839"},"modified":"2016-03-04T00:38:57","modified_gmt":"2016-03-04T05:38:57","slug":"enjoy-the-day","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2016\/03\/03\/enjoy-the-day\/","title":{"rendered":"enjoy the day…"},"content":{"rendered":"
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Guidance for the publication of clinical data<\/a><\/div>\n
Requirements for industry now available on submission of clinical data for publication<\/font><\/strong><\/div>\n
03\/03\/2016<\/div>\n

The European Medicines Agency [EMA] has published detailed guidance<\/a> for pharmaceutical companies on the requirements to comply with its policy on the publication of clinical data.<\/p>\n

EMA’s pioneering policy entered into force on 1 January 2015 and applies to clinical reports contained in all marketing-authorisation applications<\/span> submitted on or after this date. The first reports are currently foreseen to be publicly available in September 2016.<\/p>\n

"With this guidance, the Agency is moving towards the operational implementation of its proactive publication policy, which launched a new era of transparency," says Noël Wathion, EMA’s Deputy Executive Director. "The guidance will ensure that companies are aware of what is expected of them and are ready for the publication of these critical data"…<\/div>\n<\/blockquote>\n
Well it may not look like much, but it’s huge. It means that the EMA’s program to release the raw data from clinical trials is on track for September. Nothing could be much bigger in my book. I haven’t reviewed the guidance to see how much damage industry’s negotiation about redactions has done, but that’s for another day. Right now, I’m just going to enjoy the fact that the forces of good prevailed and they’re on track and moving ahead… <\/div>\n","protected":false},"excerpt":{"rendered":"

Guidance for the publication of clinical data Requirements for industry now available on submission of clinical data for publication 03\/03\/2016 The European Medicines Agency [EMA] has published detailed guidance for pharmaceutical companies on the requirements to comply with its policy on the publication of clinical data. EMA’s pioneering policy entered into force on 1 January […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[5],"tags":[],"class_list":["post-63839","post","type-post","status-publish","format-standard","hentry","category-opinion"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/63839","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/comments?post=63839"}],"version-history":[{"count":10,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/63839\/revisions"}],"predecessor-version":[{"id":63849,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/63839\/revisions\/63849"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=63839"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=63839"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=63839"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}