What role do organoids — self-organizing, stem cell-derived models of human organs — play in the rapidly evolving field of New Approach Methodologies (NAMs), and what challenges are currently hindering the translation of these insights into clinical practice? This conference aims to bridge the disciplines of ethics and law to foster a comprehensive understanding of these issues. By doing so, it seeks to address pressing questions surrounding public trust, individual rights, and the future of research involving human surrogates. The event also offers a platform to discuss how responsible innovation can support both scientific progress and societal acceptance.