Practical takes on the ICH M15 guidelines: MIDD evidence in regulatory interactions
The ICH M15 guideline provides a framework for the general principles of Model-Informed Drug Development (MIDD) and establishes a harmonized regulatory assessment framework. For teams working toward regulatory milestones, the focus is shifting toward practical implementation: specifically, how to best prepare and present model-based evidence to support decision-making.
Logistics
Lunch & learn – ASCPT
Friday March 6, 2026
12.15 PM -1.15 PM
Aurora Ballroom D
About the event
In this Lunch & learn event, Martin Bergstrand and Emma Hansson will provide insights into the evolving application of MIDD in regulatory settings. The session will cover:
- Practical considerations for putting the ICH M15 guideline into action
- Strategies for planning, generating, and presenting MIDD evidence for regulatory review
- Real-world case examples with high regulatory impact
Q & A
Why is this session important?
ICH M15 is reshaping Model-Informed Drug Development by introducing a harmonized framework for regulatory assessment of MIDD evidence. Models are no longer “nice to have”, they are becoming critical tools for regulatory decision-making. For teams approaching regulatory milestones, knowing how to apply ICH M15 in practice is essential to reduce development risk, strengthen submissions and regulatory interactions, and accelerate development timelines.
What will participants learn that they won’t get from reading the guideline?
ICH M15 describes what good practice looks like but not how to get there. This learning lab focuses on the practical implementation of MIDD: how to plan, generate, and present model-based evidence so it is meaningful and credible in regulatory review. By sharing high-impact case examples, participants will gain insight into what has successfully influenced regulatory decisions.
What will participants be able to do differently after attending this session?
Participants will leave with a clearer understanding of how to align MIDD strategies with ICH M15 expectations. They will be better equipped to frame model-based analyses around the right regulatory questions, communicate assumptions and uncertainty with confidence, and use MIDD evidence more effectively to support development and approval decisions.
Who should attend?
This learning lab is designed for pharmacometricians, clinical pharmacologists, regulatory professionals, and program or project leads involved in model-informed decision-making. Anyone responsible for translating complex modeling into clear, regulatory-ready evidence will leave with practical insights they can apply immediately.