NURA stands for ‘New Approach Methodology Use for Regulatory Application’ and is a continuing education program in the United States designed to provide professionals in the field of toxicology with specialized resources and basic hands-on training on NAMs.
In practise, NURA offers trainings, seminars, and other events to encourage the use of non-animal approaches within various regulatory frameworks. Its goal is to gather industry, government, academia, and other interested stakeholders to promote the implementation of NAMs for regulatory applications.
Recently, NURA has launched a new learning management portal containing free?toxicology trainings. The platform offers easy access to NURA resources and is available at https://nuratraining.talentlms.com/. It allows the users to navigate NURA content at their own pace, one presentation at a time, and to keep track of their progress. Users can find, skip, or replay presentations easily, and earn certificates upon course completion. This new platform also features English and Spanish subtitle options.
At the moment, the platform contains 7 different trainings:
- ‘NAMs for Medical Devices’: This course discusses the state of the art for NAMs within the context of medical device development and testing.
- ‘Nix the Six: Strategies for Implementing a Non-animal Acute Six-Pack’: The acute toxicity "six-pack" is a collection of animal tests used to evaluate acute systemic toxicity by three routes of exposure, skin and eye irritation/corrosion, and skin sensitization. This course covers ways to replace the use of animals in the "six-pack" with more effective, human-based methods.
- ‘ICE, ICE, Data: Using NICEATM’s Integrated Chemical Environment to support chemical evaluations’: NICEATM’s Integrated Chemical Environment is a free online suite that houses curated toxicity and physicochemical property data, integrated into a variety of tools to analyze and visualize chemical data. These tools provide data access adhering to FAIR principles: data that is Findable, Accessible, Interoperable, and Reusable for chemical characterization, PBPK, IVIVE, and more.
- ‘Human In, Human Out: Using Primary and Population Data for PBPK Analyses’: In silico models often offer more reliable predictions than the traditional animal-based approaches used throughout regulatory contexts. In this two-part NURA series, scientists and regulatory experts will present their application of PBPK models within a regulatory context, followed by a compelling discussion. You'll learn how we can shift the current standard of Absorption, Distribution, Metabolism, and Excretion studies to a more human-relevant standard.
- ‘AIURA: Artificial Intelligence Use for Regulatory Application’: Large language models have captivated our attention, shifted perspectives, and brought the previously unattainable within reach. Explore the future of ethical, effective regulatory science with our virtual training on advancing toxicology through artificial intelligence and machine learning.
- ‘Advancing Non-Animal Pyrogens and Endotoxins Testing’: The global landscape of pyrogens testing is changing rapidly. In this course you can learn how to use the latest in vitro methods for the assessment of pyrogenicity for pharmaceuticals and medical devices. Industry experts and the Center for Devices and Radiological Health will provide more information on how to use non-animal test methods for pyrogens and endotoxins, including Monocyte Activation Test methods and recombinant Bacterial Endotoxins Tests.
- ‘Tomorrow’s Data, Today: Sunsetting the 2-year Carcinogenicity Assay’: There is a growing consensus among experts that the current carcinogenicity assessment paradigm needs to shift from the traditional 2-year rodent “bioassay” to a more predictive, human-relevant carcinogenicity assessment. This course features international experts from regulatory, industry, and academic backgrounds working to achieve that goal.
R&D Engineer | Bioprocess Engineer | Toxicology | Regenerative Medicine | Cross-Functional Collaboration & Project Management Skills | Scientific Communication | Documentation | Data Analysis | Tennis
1 个月I’ve been looking for something like this! Seems like a great program.