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

Presentation - Session 1: Pharma industry PBPK perspective on the EMA qualification framework (N. Parrott)

Presentation - Session 1: Considerations for qualification of Physiologically Based Biopharmaceutics Models - Beyond the EMA framework (X. Pepin)

Presentation - Session 1: Harmonization of PBPK platform and model qualification for regulatory assessment (V.Lukacova)

Presentation - Session 1: Holistic qualification of mechanistic models in drug development (J-F. Schlender)

Presentation - Session 1: Introduction EU regulatory paths to acceptance of a mechanistic model (E. Manolis, C. Versantvoort)

Presentation - Session 1: Panel discussion (S. Marshall)

Presentation - Session 1: Qualification of the Simcyp platform for CYP-mediated drug-drug interactions - a Certara perspective (R. Yeo Karen)

Presentation - Session 1: Qualification of the Simcyp platform, inter-version qualification bridging (J. Masoud)

Presentation - Session 1: Risk based assessment of mechanistic models (M.Tshinanu Flora)

Presentation - Session 1: Software Verification, Validation, and Qualification of Open Source M&S Software (S.Schaller)

Presentation - Session 2: A regulatory perspective on performance verification of mechanistic models - application to PBPK-based DDI predictions (P. Colin)

Presentation - Session 2: Industry experience and discussion from a PBPK working group on the predictive performance of PBPK model for DDI applications (K.Taskar)

Presentation - Session 2: Uncertainty quantification methods for complex models used in drug development and (or) regulatory approval (A.Hooker)

Presentation - Session 3: An industry perspective on high impact QSP and QST model applications in clinical drug development in rare diseases (A.Sher)

Presentation - Session 3: Experience with software platforms qualification for mechanistic modelsfor agent-based modelling approaches; UISS case (F.Pappalardo)

Presentation - Session 3: Opportunities for application of PBPK models in special populations and different modalities (L. deZwart)

Presentation - Session 3: The landscape of QSP modelling and Virtual Population From current to best practice (A. Kulesza)

Presentation - Session 4: Cross-industry feedback in implementation of regulatory guidance on mechanistic models; case studies, gaps and challenges (P. Sharma)

Presentation - Session 4: Guideline on assessment and reporting of mechanistic models used in the context of model informed drug development (F. Musuamba Tshinanu)

Presentation - Session 4: PBBM Qualification and Guidance - key challenges and emerging opportunities (C. Mackie)

Presentation - Session 4: Shaping the path forward - advancing mechanistic models for regulatory use (H. Zhu)