04019nas a2200337   4500000000100000000000100001008004100002260001500043653002300058653001500081653001900096653001800115653002300133653001300156100002000169700002500189700002500214700001800239700002100257700002300278700002500301700002100326700002900347700001900376700002200395700002500417245011600442856006000558520304900618022001403667       2026                            d  c2026-09-0710aconfidence in NAMs10aregulators10arisk assessors10arisk managers10atailored education10aTraining1 aLorenza Nachira1 aAdele Selma Ferrario1 aWojciech Chrzanowski1 aLilas Courtot1 aKathrin Herrmann1 aJanneke Hogervorst1 aAnnalisa Gastaldello1 aWinfried Neuhaus1 aEryn Slankster-Schmierer1 aJanette Turner1 aDaniela Salvatori1 aFrancesca Pistollato00aEducational and training needs of regulatory professionals for non-animal methodologies: Insights from a survey  uhttps://www.altex.org/index.php/altex/article/view/32313 aThe 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.
Plain language summaryNon-animal new approach methodologies (NAMs) are methods that generate evidence on safety and efficacy of substances without using live animals. They have great potential in supporting the replacement and reduction of animal testing. Regulatory professionals, i.e., those responsible for making decisions based on the interpretation of this evidence, should receive appropriate training to interpret NAM-derived evidence confidently. This study surveyed 123 regulatory professionals worldwide regarding their experience with NAMs and their training needs. Respondents from industry reported more experience with NAMs than those from academia or regulatory authorities. Respondents had the least experience with advanced computer-based tools, large datasets, and human stem cell models. While many had learned through online courses and webinars, they generally preferred interactive workshops, hands-on training, case studies, and mentoring. The findings suggest that affordable, accessible, and practice-oriented training is needed to support the wider use of NAMs in regulatory decisions.  a1868-8551