Wednesday, July 15, 2026

11:15 AM - 1:15 PM

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Details

ICH M15 will soon be released as guidance for regulators and drug developers. This guideline defines for the first time results from model-based approaches as evidence for regulatory approval of medicines. This symposium will provide an overview of the evolution of modelling and simulation from a conceptual framework to a powerful decision-making tool, supporting the optimisation of experimental protocols, translation and integration of data, prediction and extrapolation across conditions, and population (e.g., age, ethnic groups). The concepts are essential for overcoming the barriers for the development of medicines for children. In parallel, the development and advancement of AI, machine learning and other platforms promises to further enhance the opportunities that model-based approaches offer for more efficient evidence generation during clinical develoment of novel molecules for paediatric diseases.

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Session chair