November 25, 2024
- News
PQKM Task Force RFI
Release of ICH Pharmaceutical Quality Knowledge Management (PQKM) Task Force Request for Information (RFI).
Showing XXX results across 3 categories.
Release of ICH Pharmaceutical Quality Knowledge Management (PQKM) Task Force Request for Information (RFI).
The ICH E6(R3) Annex 2 draft Guideline on Good Clinical Practice reached Step 2b of the ICH Process on 6 November 2024 and entered the public consultation period.
The ICH Q13 IWG “Continuous Manufacturing of Drug Substances and Drug Products” Video Training Material Modules 1-12 are now available on the ICH Website.
The Assembly of the International Council for Harmonisation (ICH) met in-person on 5 & 6 November 2024, in Montréal, Canada in parallel of meetings of 11 Working Groups and 1 Discussion Group, and preceded by meetings of the ICH Management Committee and the MedDRA Management Committee.
The ICH Secretariat is pleased to announce the publication of the updated training materials related to ICH Q9(R1) Quality Risk Management (QRM).
The ICH Secretariat is pleased to announce the publication of ICH E8(R1) General Considerations for Clinical Studies Introductory Training Video.
Monitoring the progress of international harmonisation and coordinating efforts in this regard is an important ICH focus.
Following the adoption of the E11A Guideline, a Step 4 Introductory Training Presentation has been developed by the E11A Expert Working Group.