Mapping of Existing NAMs Knowledge and Frameworks
Objectives
WP2 aims to gather, structure, and critically analyse existing knowledge on New Approach Methodologies (NAMs) relevant to the safety and efficacy assessment of chemicals and pharmaceuticals. The work package provides a comprehensive mapping of NAM-based data, regulatory frameworks, initiatives, and training resources, while identifying gaps, drivers, and promising research areas to support regulatory uptake and downstream case studies.
Meet the work package leader
Key activities
The work is structured into five core tasks:
T2.1 –
Inventory of NAMs and readiness
Mapping of NAM-based data, methods, case studies and substances. Identification of mid- and long-term promising research areas for NAM development and integration.
Task 2.2 –
Regulations, frameworks and roadmaps
Mapping regulatory texts, assessment frameworks and published roadmaps for NAM integration across chemical and pharmaceutical regulations.
Task 2.3 –
NAM initiatives and knowledge extraction
Extraction and synthesis of knowledge from ongoing and past NAM-related initiatives and projects to identify gaps, limitations, and opportunities.
Task 2.4 –
Stakeholder perception and implementation
Knowledge gathering through interviews with regulators, industry, CROs, developers and academics to identify drivers and obstacles for NAM adoption.
Task 2.5 –
Training and educational resources
Mapping of existing training, education platforms and resources on NAMs, including identification of gaps and recommendations for capacity building.
Partners involved
INERIS
WP2 coordinator and lead for T2.1
NETRI
Lead for T2.2
UOB
Lead for T2.3
Lyon Biopole
Lead for T2.4
CEHTRA
Lead for T2.5
laboratoire watchfrog
Lead for evaluating NAM usage and readiness for endocrine disruptors within T2.1
AIT
Participant
aquatox
Participant
AXELERA
Participant
UMWELTBUNDESAMT GESELLSCHAFT MIT BESCHRANKTER HAFTUNG
Participant
fc3r
Participant
iebt
Participant
ISCIII
Participant
pepper
Participant
Sanofi
Participant
STERN
Participant
Deliverables
upcoming