{"id":2085,"date":"2022-10-11T08:15:00","date_gmt":"2022-10-11T08:15:00","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/2022\/10\/11\/ich-q5ar2-draft-guideline-reaches-step-2-ich-process\/"},"modified":"2022-10-11T08:15:00","modified_gmt":"2022-10-11T08:15:00","slug":"ich-q5ar2-draft-guideline-reaches-step-2-ich-process","status":"publish","type":"post","link":"https:\/\/dev.ich.org\/index.php\/2022\/10\/11\/ich-q5ar2-draft-guideline-reaches-step-2-ich-process\/","title":{"rendered":"The ICH Q5A(R2) Draft Guideline Reaches Step 2 of the ICH Process"},"content":{"rendered":"<p>The ICH Q5A(R2) draft Guideline on Viral Safety Evaluation of Biotechnology Products reached <em>Step 2<\/em> of the ICH process on 29 September 2022.<\/p>\n<p>The R2 revision retains key principles of the original Guideline and provides additional recommendations on the established and complementary approaches to control the potential viral contamination of biotechnology products.<\/p>\n<p>A <em>Step 2<\/em> Informational Presentation has been developed by the Q5A(R2) EWG to summarise the content of the draft Guideline.<\/p>\n<p>Further information can be found on the <a href=\"https:\/\/ich.org\/page\/quality-guidelines#5-2\">Q5A(R2) page<\/a>, including the draft Guideline and the <em>Step 2<\/em> Informational Presentation available for download.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The ICH Q5A(R2) draft Guideline on Viral Safety Evaluation of Biotechnology Products reached Step 2 of the ICH process on 29 September 2022.<\/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-2085","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\/2085","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=2085"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts\/2085\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=2085"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/categories?post=2085"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/tags?post=2085"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}