Good Practices in Omics Data Interpretation for Regulatory Applications

Why

• Current frameworks guide omics data generation and reporting but lack interpretation guidance for regulatory use.​
• Focus is on addressing this gap without duplicating ongoing efforts in regulatory applications.

How

Develop best practices for quantitative hazard identification for GHS classification (C, M, R, STOT RE) by reviewing case studies on liver, testis, and genetic toxicity, and defining criteria for the toxicological relevance of molecular changes.

Deliverable

Publication on good practices/recommendations in effective toxicological interpretation of Omics data for regulatory application.

Timeline

• September 2023: kick-off meeting
• 2024: review of case studies in literature
• Q1/Q2 2025: publication