Is ICH Q9 Training a Reset for Risk Management?
Episode 34, Mar 31, 07:36 PM
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Is the new ICH Q9 training just more guidance—or a reset for how risk should be managed?
In this episode, we break down the latest training materials and what they signal for Quality Risk Management (QRM) in practice.
We cover:
- Why this release feels like a shift in expectations—not just an update
- The gap between risk tools and real decision-making
- Challenges applying dense guidance in real-world settings
- What organizations may need to rethink in existing QRM programs
If your team is focused on completing risk assessments rather than improving decisions, this episode will challenge your approach.