Sarem Sarem
Co-Chair Pharmacometrics WG, Pharmaceutical Drugs Directorate Health Canada
Seminars
Wednesday 19th November 2025
Understanding ICH M15: What Does This Mean for You? Ensuring Compliance to Accelerate Approvals & Optimize MIDD Impact
1:30 pm
- 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
Wednesday 19th November 2025
speakers
9:45 am
