EU-60: Developing in vitro methods and approaches for scientific and regulatory use

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EU 60 Summary

This module provides guidance to in vitro test method developers and others interested in ensuring the quality of new methods or approaches and in improving the efficiency with which these are developed, tested, optimised and approved by regulatory bodies. The module consists of 4 parts: 1) Context and needs for reliable and relevant in vitro methods; 2) Method development and implementation based on Good In Vitro Method Practices (GIVIMP), 3) Demonstrating the scientific validity of a new method or approach and 4) Knowledge assessment.

After completing this training module, trainees will understand the critical aspects to take into account when designing, optimising and ensuring that the newly developed in vitro methods are reliable, relevant and fit-for-purpose. Furthermore, trainees will get an overview of the different steps and target groups involved in the process of test method development, optimisation and, if applicable, in the validation of new methods and the pathways to regulatory acceptance.