TY - JOUR
KW - confidence in NAMs
KW - regulators
KW - risk assessors
KW - risk managers
KW - tailored education
KW - Training
AU - Lorenza Nachira
AU - Adele Selma Ferrario
AU - Wojciech Chrzanowski
AU - Lilas Courtot
AU - Kathrin Herrmann
AU - Janneke Hogervorst
AU - Annalisa Gastaldello
AU - Winfried Neuhaus
AU - Eryn Slankster-Schmierer
AU - Janette Turner
AU - Daniela Salvatori
AU - Francesca Pistollato
AB - 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.
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.
BT - ALTEX - Alternatives to Animal Experimentation
DA - 2026-09-07
DO - 10.14573/altex.2607011
LA - en
N2 - 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.
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.
PY - 2026
ST - Educational and training needs of regulatory professionals for non-animal methodologies
T2 - ALTEX - Alternatives to Animal Experimentation
TI - Educational and training needs of regulatory professionals for non-animal methodologies: Insights from a survey
UR - https://www.altex.org/index.php/altex/article/view/3231
Y2 - 2026-09-11
SN - 1868-8551
ER -