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


  • Amsterdam Netherlands (map)

CMAC will be attending this multistakeholder workshop, which brings together academia, regulators, and industry to explore the use of mechanistic models in drug development.

The event will focus on how mechanistic models—such as physiologically based pharmacokinetic models and quantitative systems pharmacology models—are being applied, reported, and qualified for regulatory use. It will also provide insight into the evolving guidance documents and current experiences with the regulatory landscape.

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1 October

TOPRA Symposium 2025

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15 October

Modeling and Artificial Intelligence (AI) in Generic Drug Development and Product Lifecycle Management: Regulatory Insights and Future Trends