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HMA/EMA multi-stakeholder workshop on reporting and qualification of mechanistic models for regulatory assessment
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Date/Time:

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  •   am – 4

Hosted by: European Medicines Agency, Amsterdam, the Netherlands

Event Summary: Mechanistic models are increasingly being used to support the development of medicinal products for human use. The regulatory assessment of mechanistic models is focused on determining whether the models are qualified for their intended use. Guidance documents on the requirements for reporting on and qualification of mechanistic models, covering different types of models (physiologically based pharmacokinetic models and quantitative systems pharmacology models) are currently being developed or updated.

This multistakeholder workshop will bring together academia, regulators and industry to discuss the experience with the current regulatory landscape around the application of mechanistic models to support drug development.

The aims of the workshop are to:

  • Hear the views of stakeholders and experts on the current regulatory framework around the assessment of mechanistic models.
  • Share the regulatory challenges associated with the assessment of mechanistic models with stakeholders and experts.
  • Identify opportunities for future regulatory qualification of mechanistic models.
  • Define how the current EU regulatory framework can be refined to streamline the use and assessment of mechanistic models.

Presenting from our Simulations Plus Team will be Viera Lukacova and Xavier Pepin.

Can’t Miss Presentations!

Session 1: The qualification of mechanistic models through the EMA qualification framework and beyond.

In this session, EMA wishes to interact with its stakeholders on the current landscape around the qualification of mechanistic models to support regulatory decision-making. Topics covered during the session may include: Evaluation of platform performance and qualification for specific Context-of-Use (for definition see EMA PBPK guideline), including the standards for benchmarking performance and reproducibility, required level of external evidence, reporting SOPs, version control, and software product life cycle.

Title: Harmonization of PBPK platform and model qualification for regulatory assessment
Date/Time: October, 8th 2025 / 10:30 AM CEST
Presenter: Viera Lukacova – Chief Science Officer

Title: Considerations for qualification of Physiologically-Based Biopharmaceutics Models – Beyond the EMA framework
Date/Time: October, 8th 2025 / 1:30 PM CEST
Presenter: Xavier Pepin – Vice President, PBPK Research and Development