ICH 培训库新增覆盖 11 份协调指南的培训资料

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. 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. 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. Newly available training materials are as follows (find the ICH guideline link in the heading, followed by links to training materials in the details): ICH E6(R3) – Good Clinical Practice (GCP) – The new GCP training modules join the already-published modules 1 and 4. Module 2 is in development. Module 3: Data Governance (six sub-modules), published October 2026 Module 5: Essential Records (two sub-modules), published September 2026 ICH E14/S7B Q&As (R1) – Questions & Answers: Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential ICH E14/S7B Q&As (R1) Step 4 Presentation , published September 2026 ICH M11 – Clinical electronic Structured harmonised Protocol (CeSHarP) – The ten new training modules were developed by the ICH M11 Expert Working Group M11 Training Modules , published September 2026 ICH M13B – Bioequivalence for Immediate-release Solid Oral Dosage Forms ICH M13B Step 4 Presentation , published July 2026 ICH M15 – General Principles for Model-Informed Drug Development – The new module has two files for the presentation and text. Module 1 – Example of Assessment Table, published July 2026 ICH Quality (Q) Guidelines 8 to 12 – Just published are the first four of eight planned modules on the principles and concepts governing this subset of harmonised ICH Quality Guidelines. Lesson 1: Conceptual Overview of ICH Quality Guidelines , published October 2026 Lesson 2: Understanding the Principles and Applicability of Quality Risk Management , published October 2026 Lesson 3: Quality Guideline Interactions and Considerations for Co-implementation , published October 2026 Lesson 4: A Comprehensive Systems Approach to Pharmaceutical Product Lifecycle Management , published October 2026