Title: Chapter 14; International Harmonization and Cooperation in the Validation of Alternative Methods
Authors: VIEGAS BARROSO JOAO FILIPEAHN Il YoungCALDEIRA CristianeCARMICHAEL PaulCASEY, WarrenCOECKE SandraCURREN RDESPREZ BERTRANDESKES ChantraGRIESINGER ClaudiusGUO JiabinHILL ErinJANUSCH ROI AnnettKOJIMA HLI JinLIM Chae HyungMOURA WlamirNISHIKAWA AkiyoshiPARK HyekyungPENG Shuang-QingPresgrave O.SINGER TimSOHN SoojungWESTMORELAND CarlWHELAN MauriceYANG XingfenYANG YingZUANG Valerie
Publisher: Springer
Publication Year: 2016
JRC N°: JRC103066
ISBN: 978-3-319-33824-8
ISSN: 0065-2598
URI: http://www.springer.com/series/5584
http://publications.jrc.ec.europa.eu/repository/handle/JRC103066
DOI: 10.1007/978-3-319-33826-2
Type: Articles in periodicals and books
Abstract: The development and validation of scientific alternatives to animal testing is important not only from an ethical perspective (implementation of 3Rs), but also to improve safety assessment decision making with the use of mechanistic information of higher relevance to humans. To be effective in these efforts, it is however imperative that validation centres, industry, regulatory bodies, academia and other interested parties ensure a strong international cooperation, cross-sector collaboration and intense communication in the design, execution, and peer review of validation studies. Such an approach is critical to achieve harmonized and more transparent approaches to method validation, peer-review and recommendation, which will ultimately expedite the international acceptance of valid alternative methods or strategies by regulatory authorities and their implementation and use by stakeholders. It also allows achieving greater efficiency and effectiveness by avoiding duplication of effort and leveraging limited resources. In view of achieving these goals, the International Cooperation on Alternative Test Methods (ICATM) was established in 2009 by validation centres from Europe, USA, Canada and Japan. ICATM was later joined by Korea in 2011 and currently also counts with Brazil and China as observers. This chapter describes the existing differences across world regions and major efforts carried out for achieving consistent international cooperation and harmonization in the validation and adoption of alternative approaches to animal testing.
JRC Directorate:Health, Consumers and Reference Materials

Files in This Item:
There are no files associated with this item.


Items in repository are protected by copyright, with all rights reserved, unless otherwise indicated.