Understanding ICH M15: What Does This Mean for You? Ensuring Compliance to Accelerate Approvals & Optimize MIDD Impact
Time: 1:30 pm
day: Day 1
Details:
- Outlining the key principles of the draft ICH M-15 guidelines and what they signal for industry adoption
- Understanding the M15 Harmonized Assessment Framework: Its key elements and how they provide a structured approach to support your modeling and simulation evidence
- Practical steps for aligning modeling practices with global regulatory expectations
