Regulatory Perspectives for Reliable Model Informed Drug Development (MIDD)

Authors: Sarem S
Conference: SLP MIDD+

Sarem Sarem, Biostat Unit, Office of Science Therapeutic Products Directorate, Health Canada, presents his thoughts on MIDD, Pharmacometrics, and Modeling & Simulation approaches in Phase III of drug development.

Topics covered:

  • Common model-informed drug development applications for regulatory submissions
  • Understanding the benefits and risks of a drug for the intended use and patient population
  • Good Data + Good Model + Good Analysis
  • and more!

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Presented at SLP MIDD+ Virtual Conference March 3-4, 2021

Disclaimer: This presentation reflects the views and thoughts of the author and should not be considered to represent Health Canada’s views or policies