{"id":1713,"date":"2026-10-06T12:48:54","date_gmt":"2026-10-06T12:48:54","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/guidelines\/e2e\/"},"modified":"2026-10-06T12:48:54","modified_gmt":"2026-10-06T12:48:54","slug":"e2e","status":"publish","type":"guideline","link":"https:\/\/dev.ich.org\/index.php\/guidelines\/e2e\/","title":{"rendered":"E2E \u2013 Pharmacovigilance Planning"},"content":{"rendered":"<p>The ICH Harmonised Guideline was finalised under<em> Step 4 <\/em>in November 2004.<\/p>\n<p>This Guideline is intended to aid in planning pharmacovigilance activities, especially in preparation for the early post-marketing period of a new drug (in this Guideline, the term &#8220;drug&#8221; denotes chemical entities, biotechnology-derived products, and vaccines).<\/p>\n<p>The main focus of this Guideline is on a Safety Specification and Pharmacovigilance Plan that might be submitted at the time of licence application.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The ICH Harmonised Guideline was finalised under Step 4 in November 2004. This Guideline is intended to aid in planning pharmacovigilance activities, especially in preparation for the early post-marketing period of a\u2026<\/p>\n","protected":false},"featured_media":0,"template":"","guideline_category":[9],"guideline_tag":[],"rd_phase":[],"class_list":["post-1713","guideline","type-guideline","status-publish","hentry","guideline_category-efficacy"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline\/1713","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline"}],"about":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/types\/guideline"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline\/1713\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=1713"}],"wp:term":[{"taxonomy":"guideline_category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_category?post=1713"},{"taxonomy":"guideline_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_tag?post=1713"},{"taxonomy":"rd_phase","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/rd_phase?post=1713"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}