New Approach Methodologies (NAMs) are playing an increasingly central role in biomedical and life-science research, while also breaking scientific and regulatory boundaries by moving beyond early adoption in drug development toward global implementation across health, agri-food, and environmental safety. This session will explore how cutting-edge human-relevant tools — from advanced in vitro systems and organ-on-chip platforms to AI-enabled digital twins — are transforming research, regulatory science, and product innovation across life-science and industrial ecosystems worldwide. Leading experts from regulatory agencies, industry, and the scientific community will demonstrate how NAMs are improving human relevance, accelerating discovery, and reducing development timelines, while opening new pathways for regulatory acceptance. Participants will gain insight into the rapidly evolving international landscape and the practical mechanisms needed to align validation, qualification, and data interoperability across jurisdictions, including through global cooperation frameworks.