Showing XXX results across 3 categories.
As a follow-up to the November 2025 endorsement and publication of the ICH E22 draft Guideline on General Considerations for Patient Preference Studies, the E22 Expert Working Group has issued an informational presentation and training materials.
The Cell and Gene Therapy Discussion Group, established in May 2023, has just published its recommendations paper, Recommendations with Regard to Future Advanced Therapy Medicinal Products-related Guidelines.
The International Council for Harmonisation (ICH) confirmed two new Members and two new Observers at the 51st ICH Assembly in Singapore.
The Assembly of the International Council for Harmonisation (ICH) met in person on 18-19 November 2025 in Singapore, in parallel with meetings of 12 Working Groups and preceded by meetings of the ICH Management Committee (MC) and the MedDRA Steering Committee (SC).
The Assembly of the International Council for Harmonisation (ICH) met in person on 18-19 November 2025 in Singapore, in parallel with meetings of 12 Working Groups and preceded by meetings of the ICH Management Committee (MC) and the MedDRA Steering Committee (SC).
The ICH Secretariat is pleased to announce the publication of the following training module, now available in the ICH Training Library: Interpretation and Application of ICH E6(R3): Good Clinical Practice Guideline - Module 1: Introduction and Foundational Concepts.
The ICH E2D(R1) Guideline on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports” has reached Step 4 of the ICH Process on 15 September 2025 and has now entered the implementation phase at Step 5.
In follow up to the publication of the ICH Q3E draft “Guideline for Extractables and Leachables” in August 2025, the Q3E EWG has also prepared a Step 2 informational presentation.