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

• Date:
  Wednesday, 08 October 2025 , 10:00 - 17:00 Amsterdam time (CEST)
  Thursday, 09 October 2025 , 09:00 - 16:10 Amsterdam time (CEST)
• Location:
  Online
  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 focussed 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 brings 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.

Documents

Agenda - HMA/EMA multi-stakeholder workshop on reporting and qualification of mechanistic models for regulatory assessment October 2025

Call for expression of interest to participate in the EMA multi-stakeholder workshop on reporting and qualification of mechanistic models for regulatory assessment October 2025

Live broadcast

Registration

Registration for both in-person and online participation is now closed.