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Carl Westmoreland, Hans Bender, John E. Doe, Miriam Naomi Jacobs, George E.N. Kass, Federica Madia, Catherine Mahony, Irene Manou, Gavin Maxwell, Pilar Prieto and 6 more
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 frameworks for regulatory requirements and the essential needs in education, training and greater stakeholder engagement as well the gaps in the scientific basis of NAMs.
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Westmoreland, C., Bender, H., Doe, J. E., Jacobs, M. N., Kass, G. E., Madia, F., Mahony, C., Manou, I., Maxwell, G., Prieto, P., Roggeband, R., Sobański, T., Schütte, K., Worth, A. P., Zvonar, Z., & Cronin, M. (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, 105261. https://doi.org/10.1016/j.yrtph.2022.105261
Westmoreland, Carl, et al. "Use of New Approach Methodologies (NAMs) in regulatory decisions for chemical safety: Report from an EPAA Deep Dive Workshop." Regulatory Toxicology and Pharmacology, vol. 135, 2022, pp. 105261, https://doi.org/10.1016/j.yrtph.2022.105261.
Westmoreland, Carl, Hans Bender, John E. Doe, Miriam Naomi Jacobs, George E.N. Kass, Federica Madia, Catherine Mahony, et al. "Use of New Approach Methodologies (NAMs) in regulatory decisions for chemical safety: Report from an EPAA Deep Dive Workshop." Regulatory Toxicology and Pharmacology 135 (2022): 105261. https://doi.org/10.1016/j.yrtph.2022.105261.
Westmoreland C., Bender H., Doe J. E. [и др.] Use of New Approach Methodologies (NAMs) in regulatory decisions for chemical safety: Report from an EPAA Deep Dive Workshop // Regulatory Toxicology and Pharmacology. — 2022. — Vol. 135. — P. 105261. — URL: https://doi.org/10.1016/j.yrtph.2022.105261
@article{westmoreland2022approach,
title = {{Use of New Approach Methodologies (NAMs) in regulatory decisions for chemical safety: Report from an EPAA Deep Dive Workshop}},
author = {Carl Westmoreland and Hans Bender and John E. Doe and Miriam Naomi Jacobs and George E.N. Kass and Federica Madia and Catherine Mahony and Irene Manou and Gavin Maxwell and Pilar Prieto and Rob Roggeband and Tomasz Sobański and Katrin Schütte and Andrew Paul Worth and Zvonimir Zvonar and M Cronin},
journal = {Regulatory Toxicology and Pharmacology},
year = {2022},
volume = {135},
pages = {105261},
doi = {10.1016/j.yrtph.2022.105261},
url = {https://doi.org/10.1016/j.yrtph.2022.105261}
}TY - JOUR AU - Westmoreland, Carl AU - Bender, Hans AU - Doe, John E. AU - Jacobs, Miriam Naomi AU - Kass, George E.N. AU - Madia, Federica AU - Mahony, Catherine AU - Manou, Irene AU - Maxwell, Gavin AU - Prieto, Pilar AU - Roggeband, Rob AU - Sobański, Tomasz AU - Schütte, Katrin AU - Worth, Andrew Paul AU - Zvonar, Zvonimir AU - Cronin, M TI - Use of New Approach Methodologies (NAMs) in regulatory decisions for chemical safety: Report from an EPAA Deep Dive Workshop JO - Regulatory Toxicology and Pharmacology VL - 135 SP - 105261 PY - 2022 DA - 2022/09/11 DO - 10.1016/j.yrtph.2022.105261 UR - https://doi.org/10.1016/j.yrtph.2022.105261 ER -
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