Evolving Regulatory Landscape for Model Informed Drug Development (MIDD):

Impact of the Draft ICH M15 Guidance

ON DEMAND WEBINAR
Duration: 1 hour

This webinar will explore the evolving regulatory landscape for Model-Informed Drug Development (MIDD), focusing on the impact of the recent draft ICH M15 guidance. Certara’s global experts will discuss the increasing role of MIDD across the drug development lifecycle, highlight key regulatory considerations in the application of MIDD, and provide insights on how to best leverage and implement the framework presented by the draft ICH M15 guidance within drug development programs.

Key Takeaways

  • MIDD as a Continuum 
  • Regulatory Acceptance of MIDD Solutions
  • Understanding the ICH M15 Guidance on MIDD
  • Preparing for Guidance Implementation - Future of MIDD Impact

SPEAKERS

Hannah Jones
SVP, PBPK Consultancy Services
Certara
 


Dr. Rik de Greef
SVP, Quantitative Science Services
Certara
 


Dr. Krithika Shetty
Sr. Director, Clinical Pharmacology
Certara
 


Dr. Eva Gil Berglund
Sr. Director, Regulatory Strategy
Certara
 

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