Symposium: MIDD in regulatory interactions – Practical takes on the Draft ICH M15 Guideline
Pharmetheus invites the PAGE audience to an afternoon symposium regarding application of Model-Informed Drug Development (MIDD) in Regulatory decision making. With the draft ICH M15 guideline on “General principles for model-informed drug development” recently posted for public consultation, there is an unprecedented opportunity for our community to bring MIDD to the next level.
Satellite meeting overview
Objective
The aim of this satellite symposium is to reflect on the current use of MIDD in regulatory interactions and propose practical ideas on how the Draft ICH M15 Guidelines on “General principles for model-informed drug development” can be put into action.
See the document at database.ich.org
Audience
The symposium is intended for everyone interested in the application of MIDD to support regulatory interrelations and will give opportunity for interactive discussions on this topic.
Registration
Join this afternoon symposium on Tuesday, 3rd June 2025.
Reserve your seat at the symposium
Symposium subjects
Key topics covered
Introduction to MIDD and its regulatory landscape
- Basics of MIDD and its role in regulatory settings.
Overview of the ICH M15 guidance – facts and interpretations
- A brief overview on the ICH M15 guidance document including the speaker’s opinions on practical interpretations of the draft guideline.
Expanded views on MIDD Evidence
- Absence of evidence vs. evidence of absence
- Supportive evidence vs. primary evidence
- Risk-based credibility assessment
- Practical use of ICH M15 ‘Table for Assessment of MIDD Evidence’
Model evaluation in line with the ICH M15 guideline
- Verification, validation, and applicability assessment
- Question of interest focused model diagnostics
- Technical criteria
Planning and preparing MIDD for successful regulatory interactions
- Reproducible research
- Working with interdisciplinary teams
- Efficient processes and proactive work
Examples of MIDD applications with regulatory impact
- Real-world examples highlighting regulatory impact.
Event details
Date and time
- Date: Tuesday 3rd June, 2025
- Time: 14:00 – 18:00 (includes coffee breaks)
Location
- Venue: Thessaloniki, Greece. Exact location TBC
Fees
- 185 (135*) EUR excl. VAT.
Price coffee breaks
* Early bird: The reduced early bird price applies to registrations made by 1st April .
