Helping Researchers and Developers Gain Regulatory Approval for New Approach Methodologies.
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What is the NAM Navigator?
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Timeline overview
See here an overview of the different steps necessary for validation and approval, and the associated agencies for each step.
1. Research & Development
About preparation, documentation and more
Universities
Research & Tech offices
Datasteward
Knowledge Institutes
RIVM, WFSR, TNO, et cetera
2. Standardization
About standardization in the development, implementation, and validation of NAMs.
3. Validation
What data should you have to make validation of your NAM go quicker?
Agencies for Safety Assessment of Pharmaceutical Products
Agencies for Safety Assessment of Chemical Substances
4. Acceptance
Last step after the validation study and peer-review is regulatory acceptance.
Agencies for Safety Assessment of Pharmaceutical Products
Agencies for Safety Assessment of Chemical Substances
This overview has been adapted from the RIVM “Landscape New Approach Methodologies (NAMs) safety assessment chemical substances” and the RIVM 'Landscape New Approach Methodologies (NAMs) safety assessment pharmaceutical products'.
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The NAM Navigator was commissioned by TPI under the direction of the More Knowledge with Fewer Animals program of ZonMw.
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