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Cronin, MTD, Baltazar, MT, Barton-Maclaren, TS, Bercaru, O, De Abrew, KN, Desaintes, C, Escher, SE, Kern, P, Maxwell, G, Rogiers, V, Schutte, K and Sobanski, T (2025) Report on the European Partnership for Alternative Approaches to Animal Testing (EPAA) “New Approach Methodologies (NAMs) User Forum Kick-off Workshop”. Regulatory Toxicology and Pharmacology. ISSN 0273-2300
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Report on the European Partnership for Alternative Approaches to Animal Testing EPAA New Approach Methodologies.pdf - Published Version Available under License Creative Commons Attribution. Download (849kB) | Preview |
Abstract
The European Partnership for Alternative Approaches to Animal Testing (EPAA) held the “New Approach Methodologies (NAMs) User Forum Kick-off Workshop”, at the European Chemicals Agency (ECHA), Helsinki, Finland on 7-8 December 2023. The aim of the User Forum was to gain insight into the regulatory use of NAMs, with a particular reference to Next Generation Risk Assessment (NGRA), for chemical safety assessment. To achieve this, presentations summarised the learnings and experiences of previous EPAA Skin Sensitisation User Forums as well as that of the European Commission’s Scientific Committee on Consumer Safety (SCCS). The findings of five case studies were summarised that illustrated the use of NAMs. The presentations and subsequent discussions allowed for learnings and insights to be compiled from all stakeholders with regard to the use of NAMs. Recommendations for the regulatory use of NAMs in NGRA were made namely for exposure assessment; hazard identification; using tiered and targeted testing strategies; performing risk assessment using NAM data; the practical implementation of NAMs; the use of -omics technologies; and the needs for capacity building and training. The EPAA User Forum provided an open platform for safety assessors to share learnings and experiences. Recommendations for the format and topics of future EPAA User Forums were also made.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | 1115 Pharmacology and Pharmaceutical Sciences; Toxicology; 3214 Pharmacology and pharmaceutical sciences |
| Subjects: | B Philosophy. Psychology. Religion > BJ Ethics R Medicine > RL Dermatology R Medicine > RS Pharmacy and materia medica |
| Divisions: | Pharmacy and Biomolecular Sciences |
| Publisher: | Elsevier |
| SWORD Depositor: | A Symplectic |
| Date Deposited: | 03 Mar 2025 10:01 |
| Last Modified: | 03 Mar 2025 10:01 |
| DOI or ID number: | 10.1016/j.yrtph.2025.105796 |
| URI: | https://researchonline.ljmu.ac.uk/id/eprint/25760 |
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