Reporting and Qualification of Mechanistic Models for Regulatory Assessment
Federico Reali represented COSBI at the HMA/EMA Multi-Stakeholder Workshop on Reporting and Qualification of Mechanistic Models for Regulatory Assessment, held in Amsterdam.
The event gathered representatives from regulatory agencies, industry, and academia to discuss the role of mechanistic and quantitative systems models in supporting evidence-based decisions in healthcare and drug development.
Federico’s participation highlighted COSBI’s long-standing expertise in systems biology and mechanistic modeling, built over two decades of research. These models can make “the invisible visible” — linking molecular mechanisms to clinical outcomes, and providing a quantitative foundation for model-informed regulatory science.
“Mechanistic models are not magic,” said Federico, “but they can strengthen confidence in data-driven decisions and accelerate innovation in healthcare.”
With 20 years of experience in the field, COSBI remains committed to advancing the use of mechanistic modeling to improve regulatory confidence and expand their application in the qualification of new therapies.
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