Analysis of the requirements for the validation and standardisation of NAMs
Objectives
WP5 aims to clarify the pathway toward validation and standardisation for NAM developers. This will be achieved by identifying key limitations and opportunities along this process, exploring financial structures that can support developers in overcoming these challenges and providing recommendations for validation and standardisation bodies to optimise their processes.
By engaging validation, standardisation organisations, CROs, and method developers. we will establish the foundation of a roadmap that can be utilised by NAM developers. After stakeholder dialogue, the findings will be refined into a final report.
Identify key processes, their limitations and opportunities for validation of NAMs
Identify key processes, their limitations and opportunities for international standardisation of NAMs
Explore how NAMs could be used in the context of the “one substance, one assessment” approach
Organise a workshop to facilitate dialogue and get feedback on NAM validation and standardisation from NAM developers, users and regulators.
Provide recommendations to enhance coordination between standardisation bodies to accelerate NAMs standardisation
Through these activities, WP5 will enable NAM developers to gain a clearer understanding of how to navigate the challenges of validation and standardisation, thereby contributing to a faster transition towards safer, sustainable, and animal-free chemical risk assessment.
Meet the work package leader
Key activities
Work Package 6 delivers a coordinated set of activities to ensure that NAMWISE results are effectively communicated, widely disseminated, and translated into lasting capacity-building across stakeholder groups. The work is structured into five core tasks:
Task 5.1 –
Financial mechanisms surrounding validation and standardisation:
The business model for NAM validation is a key hurdle, as there is no direct “profit” from validation studies. In this task we will conduct distribute questionnaires and interview experts to explore the financial mechanisms such as industry-funded validation, incentives in research programmes, funding of validation as part of NAM development process, and participation in EU-organised and national validation studies
Task 5.2 –
Processes surrounding validation and standardisation:
Several national and international bodies exist that validate (e.g. ECVAM, OECD, NICEATM) and standardise (e.g. OECD, ISO, CEN) NAMs. In this task we will (1) collect publicly available information such as organisational websites and scientific literature, (2) distribute questionnaires to and/or interview developers who underwent NAM validation, (3) distribute questionnaires to and/or interview validation and standardisation bodies, to map existing processes in the validation and standardisation of NAMs. We will analyse the results and identify bottlenecks vs opportunities to harmonise processes. The resulting analysis will provide guidance for NAM developers on which pathways may enable faster progress toward standardisation.
Task 5.3 –
Workshop:
We will organise an in-person workshop to evaluate the findings of T 5.1 and T5.2. We will invite a panel of hand-picked experts (NAM developers and users, regulators, and international organisations such as the OECD) to provide an unbiased review of the analysis provided by T5.1 and T5.2, identify remaining gaps and suggest possible improvements. This workshop will be organised in collaboration with the workshop WP4, to optimise the participation of the different stakeholders at these consultation events.
Task 5.4 –
Final report:
All the results from WP5 will be consolidated into a comprehensive overview of NAM validation and standardisation processes. The report will include (1) recommendations on how to optimise processes and funding structures for validation and standardisation bodies, and (2) practical information for NAM developers.
Partners involved
aQuatox – Lead Beneficiary
WP5 Coordinator
Pepper
Expert in validation and task leader of task 5.1
Charles river laboratories
Develops hands-on training materials and tutorials for CROs and lead for Task 5.4
AXELERA
Assists in stakeholder engagement and workshop organisation
ASSOCIATION LYON BIOPOLE
Manages logistics for workshops and stakeholder consultations
Produces newsletters
BIOREGIO STERN MANAGEMENT GMBH
Implements communication activities
Manages social media and video dissemination
laboratoire watchfrog
Supports training content and dissemination activities
netri
Contributes to pedagogic actions and training development
Ineris
Provides expert opinion on related topics in the Task 5.1 and 5.2
ISCIII
Provides expert opinion on related topics in the Task 5.1 and 5.2
IEBT
Provides expert opinion on related topics in the Task 5.1 and 5.2
Deliverables
| # | Deliverable Name | Description | Lead Beneficiary |
| D5.1 | Report on validation of NAMs | Suggestions for practicable business models, supporting infrastructure and regulatory awareness (T5.1) | PEPPER |
| D5.2 | Report on validation of NAMs | Description of standardisation practices, opportunities for harmonisation and the use of NAMs according to the “one substance, one assessment” reform (T5.2) | AQUA |
| D5.3 | Workshop on validation and standardisation procedures | Feedback and inputs from the stakeholders on the readiness criteria, gold standards and standardisation principles (T5.3) | LBP |
| D5.4 | Proposal on optimised use of NAMs in One Substance | Common strategies between chemicals and pharmaceuticals (T5.4) | CRL |