Showing XXX results across 3 categories.
The Integrated Addendum of the ICH E6 Guideline reached Step 2b of the ICH Process in June 2015 and now enters the consultation period (Step 3).
The ICH Expert Working Group responsible for the maintenance of the Q3C Guideline has revised the Permitted Daily Exposure (PDE) for Methyl isobutyl ketone (MIBK) and proposes to include Triethylamine as a new Class 3 solvent.
A comprehensive report of the last ICH meeting that was held in Fukuoka, Japan on 10-11 June 2015 is now available on the ICH website under the SC Reports page.
The Addendum of the ICH M7 Guideline reached Step 2b of the ICH Process in June 2015 and now enters the consultation period (Step 3).
The SC agreed on the key issues relating to the reform of ICH in terms of the Articles of Association, funding model and membership.
The ICH Steering Committee has appointed Dr. Dawn Ronan as the new Director of the ICH Secretariat.
The International Conference on Harmonisation (ICH) Steering Committee (SC) and its Expert Working Groups (EWGs) met in Fukuoka, Japan from June 5-11, 2015. The meeting was hosted by the Ministry of Health, Labour and Welfare and the Japan Pharmaceutical Manufacturers Association.
The ICH Q7 Questions & Answers on Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients reached Step 4 of the ICH Process in June 2015 and now enters the implementation period (Step 5).