This GIVIMP document is meant to serve as a technical guidance on good
scientific and quality practices to support the regulatory human safety
assessment of chemicals using in vitro methods.
Key
points:
- Validation
studies have revealed that many in vitro methods need serious improvements
in design, robustness and reliability in order to be successfully
implemented and generate data sets which can be used to support regulatory
decisions.
- In
this regard, the OECD asked the JRC EURL ECVAM to coordinate the drafting
of a guidance document on Good In Vitro Method Practices (GIVIMP) for the
development and implementation of in vitro methods for regulatory use in
human safety assessment.
- During
the meeting the JRC’s EURL ECVAM will prepare the final GIVIMP version,
which will be submitted for adoption by the OECD in April 2017.
- The
purpose of the GIVIMP guidance document is, to ensure that the overall
process - from in vitro method development to in vitro method
implementation for regulatory use - becomes more efficient and effective,
taking into account all necessary good scientific, technical and quality
practices.
Background:
- Safety
testing of chemicals is required to assess the hazards and potential risks
of chemicals to humans. Historically, in vivo tests in laboratory animals
have formed the foundation of hazard and risk assessment.
- The
European Union Reference Laboratory for alternatives to animal testing
(EURL ECVAM) has been formally established in 2011, due to the increasing
need for new methods to be developed and proposed for validation in the
European Union. EURL ECVAM is hosted by the Joint Research Centre located
in Ispra, Italy.
