Chairs: Helena Kandarova & Anne Gourmelon
The OECD Guidance Document on the validation and international acceptance of test methods for hazard assessment (“GD 34”) is being revised, taking into account the 20 years of experience in the validation of a diversity of methods applied in regulatory chemical safety testing. The modernization of the document will provide clearer criteria to determine when a method is ready for validation, peer-review and Test Guideline development. The document will provide more practical guidance on training to prepare for transferability studies, will reference other recent OECD guidance on good in vitro methods practice and guiding principles on the availability and distribution of protected elements in Test Guidelines. The updated guidance will also address the development of defined approaches, where generally results of in vitro/in silico methods are combined, using a fixed data interpretation procedure (e.g. a fonction, a rule-based procedure) to reach a conclusion of regulatory relevance. A project group has been established with experts from government and research institutes, regulatory bodies, contractual laboratories, validation platforms, industry, statisticians, and animal-welfare organisations from OECD countries. The project is jointly lead by organisations that have a strong interest and/or expertise in the validation process leading to robust methods that can be used globally to generate data that can be mutually accepted across countries for purposes of protecting human health and the environment. The expected timeline for completion of the update is 2027.
Speakers
- João Barroso, – Ready for Prime Time: Readiness Criteria for Supporting Validation
- Anne Gourmelon – Introduction to the revision of OECD Guidance Document 34 on method validation
- Damiën van Berlo- From Development to deployment – the role of readiness assessment, optimisation, training and transferability
- Roman Liska – Reproducibility evaluation revisited