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ESTIV GIVIMP/GCCP session

Programme of the Session

  • Development of an OECD guidance gocument on good in vitro method practice (GIVIMP) 
    Sandra Coecke, Gerard Bowe, Ann-Charlotte Bostroem 
    Chemicals Safety and Alternative Methods (EURL ECVAM), European Commission Joint Research Centre, Ispra, Italy
  • Requirements for publication of in vitro toxicity data 
    Bas Blaauboer 
    IRAS-Division of Toxicology, Utrecht University, Utrecht, Netherlands
  • Good Cell Culture Practice for stem cells and stem-cell-derived models 
    David Pamies 
    Environmental Science, Center for Alternatives to Animal Testing. Johns Hopkins University., Baltimore, United States
  • Serum-free Media and Serum Alternatives 
    Jan van der Valk 
    3Rs-Centre Utrecht Life Sciences, Dept. Animals in Science and Society, Fac. Veterinary Medicine, Utrecht University, Utrecht, Netherlands

Session Abstract

In vitro methods become increasingly important in fundamental and applied research to replace animal studies and to obtain reliable and relevant data. But also in vitro methods have therefore to meet certain criteria with respect to design, robustness and reliability. In particular when these methods are forwarded for a validation study in order to be used in a routine laboratory environment and generate data that can be used in a regulatory context.
The report of the Second ECVAM Task Force on Good Cell Culture Practice (GCCP) aimed  to promote the maintenance of high “standards and to reduce uncertainty in the development and application of animal and human cell and tissue culture procedures and products, by encouraging greater international harmonisation, rationalisation and standardisation of laboratory practices, quality control systems, safety procedures, recording and reporting, and compliance with laws, regulations and ethical principles”  (Coecke et al., 2005).
The development 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" was identified by the scientific and regulatory community (OECD) as a high  priority requirement to reduce the uncertainties in cell and tissue -based in vitro method  derived predictions.  The major goal of GIVIMP consists of improving the reliability and robustness of in vitro methods, reducing the uncertainties of in vitro-based predictions and therefore increasing the acceptance of the in vitro estimated safety measures by regulatory agencies.
This workshop will discuss several aspects of the recommendations put forward in both the GCCP as the draft GIVIMP document.
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