The global regulatory landscape for biomedical research and safety assessment is undergoing a profound transformation, driven by the growing recognition of the scientific limitations of traditional research models and frameworks and the need for more predictive, human-relevant approaches. In the United States, recent legislative and regulatory developments have increased flexibility in the acceptance of New Approach Methodologies (NAMs), accelerating the use of non-animal data in regulatory decision-making and setting important international precedents.

Within this evolving global context, Europe is pursuing a structured and coordinated transition toward human relevant models through policy roadmaps, regulatory reforms, and dedicated infrastructures. Initiatives such as BimmoH, the first AI-powered public database dedicated to experimental models based on human biology, and the forthcoming European roadmap to modernize healthcare and research approaches, signal a clear commitment to data-driven, human-based innovation. At the same time, organ-on-chip technologies are enabling more integrated, mechanistic, and predictive testing strategies, with the potential to support regulatory confidence and practical implementation.

This webinar will focus on the European perspective, while drawing meaningful comparisons with developments in the United States, to explore how AI and organ-on-chip technologies can support the transition from policy ambition to regulatory practice.

Through a panel discussion bringing together expertise at the interface of science, policy, and technology development, the session will examine current European actions, key implementation challenges, and the conditions required for pragmatic, coordinated, and measurable adoption of NAMs.