Case Studies on Reliability and Relevance Considerations during Validation of NAMs

Why

• Validation of NAMs is often overlooked despite its importance for regulatory use.
• Traditional validation methods are less suitable for NAMs, which focus on key events rather than apical endpoints.
• New approaches are needed to assess reliability and relevance, with OECD Guidance Document No. 34 updates offering a potential path forward.

Objectives

• Gather insights on experiences, concerns, and expectations, including which aspects should be addressed by validation and which by other processes.
• Consider conducting a survey among diverse stakeholders (e.g., ECVAM, OECD, academics) to identify scientific and communication challenges.
• Use case studies (e.g., DNT, fish bioaccumulation) to illustrate challenges and opportunities in developing smart, effective, and relevant validation strategies.

Timeline and Deliverables

• Discussion paper on meaning of reliability and relevance for different parties (e.g. academic, regulators, industry) via two case studies covering more novel endpoints such as DNT, fish bioaccumulation test etc.

The Task Force kicked off in January 2025 and aims to publish their findings during 2026.