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  3. ICH M15: Planning, evaluating and communicating MIDD evidence

ICH M15: Planning, evaluating and communicating MIDD evidence

Transform complex modeling data into clear, compliant submission packages that pass regulatory review.

Webinar overview

This webinar bridges the gap between regulatory theory and practical application. We will walk through the full MIDD evidence lifecycle: defining the initial regulatory question and Context of Use (CoU), assessing model credibility and risk, and presenting the evidence clearly and consistently for regulatory review.

A real-world case study will illustrate how the principles reflected in ICH M15 can be applied in practice to structure the evidence assessment and support a regulatory decision.

Key topics covered

ICH M15 provides a common framework for planning, evaluating, and communicating MIDD evidence in support of regulatory decision-making. But what does that look like in practice?

Join our webinar to learn:

  • How to apply the guideline across the full MIDD evidence lifecycle, from defining the regulatory question and Context of Use (CoU) to assessing model credibility, evaluating risk, and presenting clear evidence for regulatory review.

  • How ICH M15 principles directly support successful regulatory decisions, demonstrated through a practical, step-by-step case study.

  • How ICH M15 enables earlier planning, stronger cross-functional alignment, and more consistent evidence reporting, while practical submission-readiness strategies help teams work efficiently under tight timelines.

Presenters

Senior Director, Regulatory Affairs

Emma Hansson

See bio

Principal Director, MIDD Scientific Lead

Martin Bergstrand

See bio

Target audience

This webinar is relevant for professionals working in pharmacometrics, clinical pharmacology, regulatory strategy, clinical development, statistics, and related functions who are involved in planning, evaluating, or communicating MIDD evidence for regulatory decision-making.

Webinar details

The event has passed


Contact

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753 19 Uppsala, Sweden

Visiting address: 

Dragarbrunnsgatan 77, 5th floor

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About Pharmetheus

Pharmetheus is a consultancy firm helping clients reduce uncertainty in technical and regulatory processes, increasing confidence in the development of new medicines that can improve patients’ lives.

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