ICH Publishes New Training Material for Quality Guidelines

From July through September, ICH 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 cover training modules on:

• ICH E6(R3) - Good Clinical Practice (GCP)
• ICH E14/S7B Q&As (R1) - Questions & Answers: Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential
• ICH M11 - Clinical electronic Structured harmonised Protocol (CeSHarP)
• ICH M13B - Bioequivalence for Immediate-release Solid Oral Dosage Forms
• ICH M15 - General Principles for Model-Informed Drug Development

And 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
• Lesson 2: Understanding the Principles and Applicability of Quality Risk Management
• Lesson 3: Quality Guideline Interactions and Considerations for Co-implementation
• Lesson 4: A Comprehensive Systems Approach to Pharmaceutical Product Lifecycle Management

Source: ICH News