About us
New Approach Methodologies (NAMs) hold the potential to deliver human-relevant, accurate, reproducible and sustainable innovations in biomedical research, which may directly or indirectly reduce the reliance on animal testing. Although Member States are required by Directive 2010/63/EU to replace animal procedures in research, education and regulatory testing with valid alternative approaches when available, their acceptance and uptake has progressed slowly.
To support the use of these alternative methods, this ERA action (ERA4NAMs) will bring together all relevant groups, including ministries, academia, regulatory agencies, and the pharmaceutical and medical technology industries, to align national and regional policies to speed up the development, validation, acceptance, and uptake of NAMs. The expected outcomes are:
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NAM development and infrastructure agenda identifying priority areas (Q4 2027).
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Joint actions by Member States and stakeholders to support new NAMs and related infrastructures (Q1 2028).
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NAM acceptance and uptake strategy defining criteria for regulatory use (Q3 2027).
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Joint validation and qualification of NAMs for regulatory testing (Q4 2027-Q3 2028).
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NAM education and training plan (Q1 2027) and joint training programmes (Q2 2027-Q2 2028).
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Harmonised openness and awareness programme improving access to NAMs protocols and results, with guidance for ethics and regulatory bodies (Q2 2028).
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Major awareness-raising conference for civil society and patients (Q3 2028).
WG3 Education and Training is responsible for mapping and assessing existing NAM/3Rs training, identifying best practices and gaps, and translating this into a European education and training plan plus joint training programmes that help researchers, regulators and institutions build the skills needed for the uptake of NAMs.
Currently, WG 3 conducts mapping of training and education in the EU and beyond.
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