Showing XXX results across 3 categories.
The ICH M11 Expert Working Group has issued a final overview presentation (at Step 4 of the ICH harmonisation process) for ICH M11: The Clinical electronic Structured Harmonised Protocol (CeSHarP), a guideline adopted in November 2025.
ICH has issued an overview training module for harmonised Guideline ICH M15: General Principles for Model-Informed Drug Development. The M15 Guideline was adopted in January of this year.
ICH has published an updated and expanded Q9(R1) Quality Risk Management Briefing Pack to support the implementation of a systematic approach to quality risk management in pharmaceutical development, manufacturing and distribution.
ICH has published the final training module, “Implementation Guide for Electronic Transmission of Individual Case Safety Reports, Module III” for Guideline E2B(R3), one of several related guidelines on Clinical Safety Data Management.
The ICH M4Q(R2) Expert Working Group has developed a mock example to illustrate the potential structure and presentation of information in the revised Modules 2.3 and 3 of the Common Technical Document – Quality.
The ICH M15 Guideline, General Principles for Model-informed Drug Development, has been adopted and will now enter the implementation phase.
The minutes of the ICH Management Committee and ICH Assembly meetings held in Singapore at ICH51 have been published. These documents summarise the decisions taken and topics discussed during the face-to-face biannual meetings, which took place in November 2025.
Three ICH Expert Working Groups have issued an updated document package, a mapping document and training materials, respectively, associated with three technical Guidelines: E2B(R3), M4Q(R2) and E6(R3).