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Use of New Approach Methodologies (NAMs) in regulatory decisions for chemical safety: Report from an EPAA Deep Dive Workshop

Westmoreland, C, Bender, HJ, Doe, JE, Jacobs, MN, Kass, GEN, Madia, F, Mahony, C, Manou, I, Maxwell, G, Prieto, P, Roggeband, R, Sobanski, T, Schütte, K, Worth, AP, Zvonar, Z and Cronin, MTD (2022) Use of New Approach Methodologies (NAMs) in regulatory decisions for chemical safety: Report from an EPAA Deep Dive Workshop. Regulatory Toxicology and Pharmacology, 135. p. 105261. ISSN 0273-2300

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New Approach Methodologies (NAMs) are considered to include any in vitro, in silico or chemistry-based method, as well as the strategies to implement them, that may provide information that could inform chemical safety assessment. Current chemical legislation in the European Union is limited in its acceptance of the widespread use of NAMs. The European Partnership for Alternative Approaches to Animal Testing (EPAA) therefore convened a ‘Deep Dive Workshop’ to explore the use of NAMs in chemical safety assessment, the aim of which was to support regulatory decisions, whilst intending to protect human health. The workshop recognised that NAMs are currently used in many industrial sectors, with some considered as fit for regulatory purpose. Moreover, the workshop identified key discussion points that can be addressed to increase the use and regulatory acceptance of NAMs. These are based on the changes needed in regulatory requirements frameworks and the essential needs in education, training and greater stakeholder engagement as well the gaps in the scientific basis of NAMs.

Item Type: Article
Uncontrolled Keywords: 1115 Pharmacology and Pharmaceutical Sciences; Toxicology
Subjects: R Medicine > RS Pharmacy and materia medica
Divisions: Pharmacy & Biomolecular Sciences
Publisher: Elsevier
SWORD Depositor: A Symplectic
Date Deposited: 12 Sep 2022 11:29
Last Modified: 27 Sep 2022 11:45
DOI or ID number: 10.1016/j.yrtph.2022.105261
URI: https://researchonline.ljmu.ac.uk/id/eprint/17539
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