As regulatory expectations evolve, model-informed drug development (MIDD) is no longer optional, it is increasingly central to decision-making, particularly in the context of streamlined development programs and single pivotal studies. Yet, while the use of PBPK, QSP, and other mechanistic models is growing, regulatory acceptance still hinges on one critical factor: credibility.

What makes a model “credible” in the eyes of regulators? Why do some models meaningfully inform decisions, while others raise concerns or are discounted entirely?

In this follow-up to Regulatory Horizons: Global Insights 2026, former regulators and clinical pharmacology experts will provide practical guidance on how to increase regulatory confidence in your models. The discussion will go beyond theory to focus on real-world decision-making: identifying common red flags, defining appropriate context of use, and demonstrating the totality of evidence needed to support model-informed claims.

The session will also explores how the evolving regulatory landscape, including increased reliance on single pivotal studies, is raising the bar for mechanistic and quantitative evidence, making well-positioned and well-communicated models more important than ever.

Attendees will leave with actionable strategies to move from simply including models in submissions to ensuring they are trusted, decision-enabling components of the regulatory package.

What you’ll learn

In this on-demand webinar, you will learn to:

• Define model credibility from a regulatory perspective
  Understand how agencies assess plausibility, assumptions, validation, and fitness for purpose.
• Identify common modeling red flags that undermine regulatory confidence
  Recognize pitfalls that can lead to questions, delays, or rejection of model-informed evidence.
• Apply key principles of ICH M15 and context of use
  Ensure models are appropriately designed, justified, and aligned with their intended regulatory purpose.
• Demonstrate the totality of evidence needed to support model-informed decisions
  Integrate clinical, nonclinical, and mechanistic data to strengthen submissions.
• Translate models into regulatory decision-making tools
  Effectively link pharmacology, exposure, and clinical outcomes in a way that resonates with reviewers.
• Implement strategies to increase regulatory acceptance and trust
  Use communication, transparency, and early engagement to improve the likelihood that models are relied upon, not just included.

Who should watch

This webinar is designed for professionals involved in clinical pharmacology, pharmacometrics, and model-informed drug development (MIDD) who are responsible for generating or defending model-based evidence in regulatory submissions.

Primary audience:

• Clinical Pharmacologists
• Pharmacometrics / PK-PD Scientists
• PBPK and QSP Modelers
• MIDD / Quantitative Sciences Leaders

Extended stakeholders:

• Regulatory Affairs professionals supporting model-informed strategies
• Translational Medicine and Early Development teams
• Clinical Development scientists involved in dose selection and study design
• CMC and cross-functional team members involved in bridging or integrated evidence packages