From July through September, ICH has published newly developed training materials for four ICH harmonised guidelines, a two-guideline Q&A, and the principles and concepts governing a group of five ICH Quality Guidelines.<\/p>\n
Training materials range from overview presentations to multi-module training packages with videos and transcripts. Some materials were developed by the ICH Expert Working Groups that developed the relevant guidelines or by specially constituted Implementation Working Groups. Others were developed by ICH Training Associates, which are typically non-profit academic institutions with guideline-specific expertise.<\/p>\n
ICH supports the development of high-quality training materials as part of its efforts to increase globally harmonised implementation of ICH guidelines. New training materials are published regularly in the ICH Training Library.<\/p>\n
Newly available training materials are as follows (find the ICH guideline link in the heading, followed by links to training materials in the details):<\/p>\n
ICH E6(R3) \u2013 Good Clinical Practice (GCP)<\/strong><\/a> \u2013 The new GCP training modules join the already-published modules 1 and 4. Module 2 is in development.<\/p>\n ICH E14\/S7B Q&As (R1) \u2013 Questions & Answers: Clinical and Nonclinical Evaluation of QT\/QTc Interval Prolongation and Proarrhythmic Potential<\/strong><\/a><\/p>\n ICH M11 \u2013 Clinical electronic Structured harmonised Protocol (CeSHarP)<\/strong><\/a> \u2013 The ten new training modules were developed by the ICH M11 Expert Working Group<\/p>\n ICH M13B \u2013 Bioequivalence for Immediate-release Solid Oral Dosage Forms<\/strong><\/a><\/p>\n ICH M15 \u2013 General Principles for Model-Informed Drug Development<\/strong><\/a> \u2013 The new module has two files for the presentation and text.<\/p>\n ICH Quality (Q) Guidelines 8 to 12 \u2013 <\/strong>Just published are the first four of eight planned modules on the principles and concepts governing this subset of harmonised ICH Quality Guidelines.<\/p>\n ICH has recently published newly developed training materials for four ICH harmonised guidelines, a two-guideline Q&A, and the principles and concepts governing a group of five ICH Quality Guidelines.<\/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-1989","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\/1989","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=1989"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts\/1989\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=1989"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/categories?post=1989"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/tags?post=1989"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}\n
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