Explore the growing role of physiologically based pharmacokinetic (PBPK) modelling in regulatory submissions and its impact on model-informed drug development (MIDD).

This webinar, hosted by Pharmaron, will feature two expert presentations highlighting recent trends in PBPK model analyses for regulatory contexts and practical case examples of MIDD in action. Following the talks, an interactive Q&A will address common challenges, best practices, and strategies for leveraging PBPK modelling to meet regulatory expectations.

What You’ll Learn

Attendees will gain a deeper understanding of:

• The Journey of PBPK M&S Applications in Regulatory Submissions
  •  Introduction
  • Recent Trend of PBPK Model Analyses in Regulatory Submissions
• What Do We Need for from PBPK Modelling for a Successful submission?
• What is the purpose of a model
• MIDD in practice (Case examples)
  • MIDD submission and what is required from a model (DDI example)
  • Specific population examples and what is expected from a regulatory standpoint

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Moderator:

• Michael Bestwick – DMPK Director, Drug Discovery at Pharmaron

Speakers: 

• Susie Zhang – Regulatory Strategies at Simulations Plus
• Simon Teague – Senior Director, PBPK Drug Discovery at Pharmaron