GRACIOUS Framework and Guidance Document

Objective:

• To exploit relevant strategies and tools in order to design a state-of-the-art Framework for grouping, read-across and classification of NMs/NFs for both regulatory risk assessment and business decision making for safer design of quality products
• To engage key stakeholders and experts from regulation, industry, and other relevant communities (e.g. academia, standardisation and civil society) in developing a Framework that truly reflects their requirements for grouping, classification and read-across.
• To coordinate the development of the GRACIOUS grouping ITSs (cf. WP2-6) and to develop the methodologies needed to integrate these strategies and their underlying tools into a coherent Framework.
• To design, test and provide feedback on the Framework to allow its continual improvement.
• To deliver the final Framework as a science-based Guidance Document compliant with regulatory needs.

List of tasks:

• Acquire full details of existing strategies for grouping, classification and read across, and of relevanttools (computational models, experimental protocols).
• Draft a Framework to enable strategies to grouping, read-across and classification of NMs/NFs.
• Organise and hold an expert/stakeholder workshop (in conjunction with WP7) to discuss the relevance of the proposed Framework.
• Modify the draft Framework to address stakeholder input and finalise the work plan for each WP accordingly.
• Challenge strategies to enable the tools to function and interact effectively.
• Test the performance of the GRACIOUS Framework.
• Generate component descriptions leading to a Guidance Document based on the GRACIOUS Framework.

WP Leader:  Vicki Stone, HWU