Educational and training needs of regulatory professionals for non-animal methodologies: Insights from a survey

The increasing application of non-animal new approach methodologies (NAMs) in regulatory decision-making requires regulatory professionals to develop new competencies to confidently interpret data derived from this expanding array of methods. Tailored educational programs could facilitate this, but little research has examined the specific educational needs and preferences of regulatory professionals across sectors. This cross-sectional survey aims to address this gap and generate actionable insights for designing such programs. An online questionnaire was administered to regulatory professionals worldwide between July and December 2025. Quantitative data were analyzed descriptively, including bivariate descriptive analyses; thematic analysis was conducted on qualitative data. Among the 123 respondents, regulatory professionals employed by industry reported having used/assessed NAMs more often than those employed by academia or regulatory authorities. Frequent use/assessment of NAMs was highest in respondents from the cosmetics sector, and lowest in the veterinary and human pharmaceuticals and medical devices sectors. Experience levels were lowest for advanced in silico tools, large data sets, and human stem cell models. Respondents learned about NAMs most frequently through online courses and webinars, while interactive workshops, hands-on sessions, case studies, and mentoring were considered the most effective formats. Funding considerations were frequently mentioned in open-format answers. These results support the co-design of educational and training opportunities tailored to regulatory professionals' different roles and levels of expertise on NAMs, integrating practical sessions and real-world case studies, and including strategies to ensure widespread affordability and accessibility. Such opportunities may help strengthen confidence in application of NAM data to regulatory decision-making.