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Raffaella Corvi,¹ Hans-Jürgen Ahr,² Silvio Albertini,³ David H. Blakey,⁴ Libero Clerici,⁵ Sandra Coecke,¹ George R. Douglas,⁴ Laura Gribaldo,¹ John P. Groten,⁶ Bernd Haase,⁷Karen Hamernik,⁸Thomas Hartung,¹ Tohru Inoue,⁹ Ian Indans,¹⁰ Daniela Maurici,¹ George Orphanides,¹¹ Diana Rembges,⁵ Susanna-Assunta Sansone,¹² Jason R. Snape,¹³ Eisaku Toda,¹⁴ Weida Tong,¹⁵ Joost H. van Delft,¹⁶ Brenda Weis,¹⁷ and Leonard M. Schechtman^18,19

¹European Centre for the Validation of Alternative Methods (ECVAM), Institute for Health and Consumer Protection (IHCP), Joint Research Centre of the European Commission (JRC), Ispra, Italy; ²Bayer HealthCare AG, Wuppertal, Germany; ³Hoffmann-La Roche, Basel, Switzerland; ⁴Environmental Health Centre, Health Canada, Ottawa, Ontario, Canada; ⁵Physico-Chemical Exposure, IHCP, JRC, Ispra, Italy; ⁶TNO, Utrecht, the Netherlands; ⁷QIAGEN, Hilden, Germany; ⁸U.S. Environmental Protection Agency, Washington, DC, USA; ⁹National Institute of Health Sciences, Tokyo, Japan; ¹⁰Health Safety Executive, London,United Kingdom; ¹¹Syngenta, Macclesfield, United Kingdom; ¹²European Molecular Biology Laboratory, European Bioinformatics Institute, Hinxton, Cambridge, United Kingdom; ¹³AstraZeneca, Brixham, United Kingdom; ¹⁴Organisation for Economic Co-operation and Development, Paris, France; ¹⁵Food and Drug Administration, National Center for Toxicological Research, Jefferson, Arkansas, USA; ¹⁶University of Maastricht, Maastricht, the Netherlands; ¹⁷National Institute of Environmental Health Sciences, National Institutes of Health, Department of Health and Human Services, Research Triangle Park, North Carolina, USA; ¹⁸U.S. Interagency Coordinating Committee on the Validation of Alternative Methods, Research Triangle Park, NC, USA; ¹⁹U.S. Food and Drug Administration, National Center for Toxicological Research, Rockville, Maryland, USA

Abstract
This is the report of the first workshop "Validation of Toxicogenomics-Based Test Systems" held 11-12 December 2003 in Ispra, Italy. The workshop was hosted by the European Centre for the Validation of Alternative Methods (ECVAM) and organized jointly by ECVAM, the U.S. Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) , and the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) . The primary aim of the workshop was for participants to discuss and define principles applicable to the validation of toxicogenomics platforms as well as validation of specific toxicologic test methods that incorporate toxicogenomics technologies. The workshop was viewed as an opportunity for initiating a dialogue between technologic experts, regulators, and the principal validation bodies and for identifying those factors to which the validation process would be applicable. It was felt that to do so now, as the technology is evolving and associated challenges are identified, would be a basis for the future validation of the technology when it reaches the appropriate stage. Because of the complexity of the issue, different aspects of the validation of toxicogenomics-based test methods were covered. The three focus areas include a) biologic validation of toxicogenomics-based test methods for regulatory decision making, b) technical and bioinformatics aspects related to validation, and c) validation issues as they relate to regulatory acceptance and use of toxicogenomics-based test methods. In this report we summarize the discussions and describe in detail the recommendations for future direction and priorities. Key words: acceptance, alternatives, biomarker, predictive test, regulatory use, standardization, toxicogenomics, toxicology, validation. Environ Health Perspect 114:420-429 (2006) . doi:10.1289/ehp.8247 available via http://dx.doi.org/ [Online 17 August 2005]

Address correspondence to R. Corvi, European Centre for the Validation of Alternative Methods, IHCP, Joint Research Centre of the European Commission, Via E. Fermi 1, 21120 Ispra, Italy. Telephone: 39-0332-785266. Fax: 39-0332-785845. E-mail: raffaella.corvi@jrc.it

Supplemental Material is available online (http://ehp.niehs.nih.gov/members/2005/8247/suppl.pdf) .

We gratefully acknowledge W.S. Stokes, Director of the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods, for contributions to the planning and organization of the workshop as well as insightful and constructive comments.

This document represents the consensus of the participants' views expressed as individual scientists and does not necessarily represent the policies and procedures of their respective institutions.

The authors declare they have no competing financial interests.

Received 22 April 2005 ; accepted 17 August 2005.