PRINCIPLE AIMS OF THE TRAINING:
At the completion of this EURION 2020 validation training, participants will:-
- Understand the critical aspects to take into account when designing, optimising and ensuring the reliability, relevance and fitness-for-purpose of newly developed in vitro
- Get an overview of the different players involved in the process of test method development, optimisation and if applicable, the agencies involved in the validation of new methods and the pathways to regulatory acceptance.
The training will address the critical aspects of quality for in vitro methods, as described in the OECD Good In Vitro Method Practices (GIVIMP) document, and will illustrate how application of these principles improves the scientific integrity of new methods and may speed up regulatory acceptance of new proposed methods. The applicability/extrapolation of these principles to in vivo methods will also be discussed.