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On-Demand Webinar

Final ICH M15 Guidance: Aligning MIDD with Global Regulatory Expectations

Final ICH M15 Guidance: Aligning MIDD with Global Regulatory Expectations

Original air date: Tuesday, May 5, 2026

The finalization of the ICH M15 guideline marks a pivotal moment for Model-Informed Drug Development (MIDD). For the first time, global regulatory authorities have established a harmonized framework for assessing and communicating MIDD applications in a regulatory context.

ICH M15 signals a shift in how modeling is used, not as a standalone analysis, but fully integrated, as a strategic, decision-enabling framework across the entire drug development lifecycle.

In this webinar, Certara experts across regulatory strategy, clinical pharmacology, pharmacometrics, Quantitative Systems Pharmacology (QSP), and modeling technologies will explore how sponsors can operationalize MIDD in alignment with ICH M15. The discussion will focus on how to connect modeling approaches, regulatory expectations, and decision-making, from early development through global submission, into a cohesive and impactful strategy.

What we cover

  • M15 Key components
    Building a MIDD strategy to address drug development questions
  • Designing an end-to-end MIDD strategy
    Embedding modeling into clinical pharmacology and regulatory strategies across the development lifecycle
  • MIDD in practice: case-based insights
    How integrated modeling approaches (PopPK, PK/PD, PBPK, QSP, MBMA) inform key development decisions through real-world application
  • Integrated modeling for decision-making
    How modeling approaches collectively support dose selection, trial design, labeling, and benefit–risk assessment
  • Regulatory frameworks and considerations
    Context of use, uncertainty in mechanistic models, EMA qualification pathways, Bayesian approaches, and alignment with emerging guidance such as ICH E21
  • Enabling MIDD with modern platforms
    How modern tools guide modelers to the appropriate model, support objective model selection across the full model space, and ensure reproducibility through code-based workflows and GUI-to-code translation

Why it matters

ICH M15 raises expectations but also creates opportunity. Sponsors who can clearly demonstrate how models inform decisions will be better positioned to reduce uncertainty, streamline development, and strengthen regulatory confidence.

When applied effectively, MIDD becomes the connective framework that links data, models, and decisions, driving more efficient and informed drug development.

By watching, participants will:

  • Understand how to align end-to-end MIDD strategies with ICH M15 expectations
  • Learn how regulators assess model credibility in the context of decision impact and risk
  • Gain a practical framework for implementing MIDD across the drug development lifecycle
  • See how integrated modeling approaches strengthen decision-making and regulatory submissions
  • Explore best practices for generating reproducible, regulator-ready modeling evidence
  • Understand the expanding role of QSP and mechanistic modeling in development and regulatory decision-making

Who should watch

This webinar is designed for professionals involved in drug development and regulatory strategy who are looking to apply modeling and simulation more effectively across the development lifecycle.

  • Clinical pharmacology, pharmacometrics, and modeling experts
  • Regulatory affairs and regulatory strategy professionals
  • Clinical development and translational science leaders
  • Scientists and teams applying PBPK, PK/PD, or QSP approaches
  • R&D and drug development decision-makers

Ideal for organizations

  • Pharmaceutical and biotechnology companies
  • Contract research and development organizations (CROs/CDMOs)

Best Fit for Those Who

  • Are integrating Model-Informed Drug Development (MIDD) into their programs
  • Are preparing for or supporting regulatory submissions
  • Want to align with evolving global expectations such as the ICH M15 guideline
  • Are making strategic decisions across Phase 1–3 development
  • Want to use M15 to its fullest potential

Speakers:

  • Eva Berglund, PhD, Vice President, Clinical Pharmacology and Regulatory Strategy
  • Paul Matthias Diderichsen, VP Regional Lead Europe/Africa, Quantitative Science Services
  • Karen Rowland Yeo, PhD, Senior Vice President, Client & Regulatory Strategy
  • Piet van der Graaf, Senior Vice President and Head of Quantitative Systems Pharmacology
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