Sarem Sarem

Sarem Sarem

Company: Health Canada

Job title: Co-Chair Pharmacometrics WG, Pharmaceutical Drugs Directorate

Seminars:

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 expectationsRead more

day: Day 1

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