The International Council for Harmonization’s Q12 guideline on lifecycle management appears headed for final approval in November, with progress reported on efforts to resolve a conflict with the EU variations legislation, as well as on efforts to bring greater clarity to the concept of established conditions outlined in a draft version of the document.
Moheb Nasr, a member and former rapporteur of the ICH Q12 Expert Working Group, provided an update on the guidance at the CASSS CMC Strategy Forum on 15 June in...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?