HMA/EMA multi-stakeholder workshop on reporting and qualification of mechanistic models for regulatory assessment held the 8 and 9 October 2025: publication of the video recordings and presentation materials
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 brought 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 video recordings and the presentation materials of the event are now available on the EMA Website.
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vroby (11 décembre 2025). HMA/EMA multi-stakeholder workshop on reporting and qualification of mechanistic models for regulatory assessment held the 8 and 9 October 2025: publication of the video recordings and presentation materials. ELSIBI. Consulté le 7 octobre 2026 à l’adresse https://doi.org/10.58079/15bus
