Report on the European Partnership for Alternative Approaches to Animal Testing (EPAA) “New Approach Methodology (NAMs) User Forum”, 30 – 31 October 2024, Helsinki, Finland

Cronin, MTD ORCID: 0000-0002-6207-4158, Cable, S, Desaintes, C, Escher, SE, Hessel, E, Fritsche, E, Kern, P, Maxwell, G, Ouedraogo, G, Sobanski, T, Wehr, M and White, A (2025) Report on the European Partnership for Alternative Approaches to Animal Testing (EPAA) “New Approach Methodology (NAMs) User Forum”, 30 – 31 October 2024, Helsinki, Finland. Regulatory Toxicology and Pharmacology. p. 105980. ISSN 0273-2300

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Abstract

The European Partnership for Alternative Approaches to Animal Testing (EPAA) held the “New Approach Methodology (NAMs) User Forum” at the European Chemicals Agency, Helsinki, Finland on 30 – 31 October 2024. The User Forum brought together stakeholders from regulatory agencies, industry, non-governmental organisations (NGOs) and academia, as well as European Union competent authorities. Lessons learned from applying NAMs for regulatory use were provided by the European Food Safety Authority (EFSA) and European Chemicals Agency (ECHA). Progress in the development of the developmental and neurotoxicity in vitro battery (DNT IVB) and Alternative Safety Profiling Algorithm (ASPA) were described, as well as five case studies describing uses of NAMs for chemical safety assessment. The presentations confirmed progress in NAMs and, in particular, the value of tiered testing strategies to bring together different lines of evidence. Specifically, tiered testing strategies for non-animal information are organised into three tiers, which may be relevant to hazard, exposure and toxicokinetic information. Progress into, and the needs for improvement of, the tiered strategies were discussed with a particular focus on the types of NAMs (in silico and in vitro) that may be required at each tier and the how confidence may be assigned to making a decision.

Item Type:	Article
Uncontrolled Keywords:	1115 Pharmacology and Pharmaceutical Sciences; Toxicology; 3214 Pharmacology and pharmaceutical sciences
Subjects:	R Medicine > RA Public aspects of medicine > RA1190 Toxicology. Poisions R Medicine > RS Pharmacy and materia medica
Divisions:	Pharmacy and Biomolecular Sciences
Publisher:	Elsevier
Date of acceptance:	22 October 2025
Date of first compliant Open Access:	27 October 2025
Date Deposited:	27 Oct 2025 12:23
Last Modified:	27 Oct 2025 12:30
DOI or ID number:	10.1016/j.yrtph.2025.105980
URI:	https://researchonline.ljmu.ac.uk/id/eprint/27422

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