ICH: Updated Q9(R1) Briefing Pack
The ICH has fully revised the Q9(R1) Briefing Pack (March/April 2026) to align with the updated ICH Q9 guideline.
Together with ICH Q8(R2) and ICH Q10, Q9(R1) forms the foundation for science- and risk-based quality approaches.
The guideline continues to emphasise two core principles of Quality Risk Management:
- risk evaluation based on scientific knowledge with a focus on patient protection
- level of effort and documentation commensurate with the level of risk
The updated Briefing Pack includes 18 fully revised training materials and a new presentation on supply chain risk management, covering QRM methods and their applications.
Source:
ICH: News
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