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 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.

Registration

You can register for the workshop at the following link: EUSurvey

For in-person participation, please register by 15 June 2025. Participation will be subject to confirmation after the deadline to ensure equal and diverse input from all stakeholders and considering room capacity. No travel booking should be made before receiving confirmation of in-person participation from EMA. 

Registration for online participation will remain open until 15 September 2025.

Documents

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

Draft

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

Video recording

Video recording is made available after the event.