Optimisation of the post-validation process: the report and recommendations of ECVAM Workshop 67.

This is the report on Optimisation of the Post-validation Process, one of a series of workshops organised by the European Centre for the Validation of Alternative Methods (ECVAM). ECVAM’s main goal, as defined in 1993 by its Scientific Advisory Committee, is to promote the scientific and regulatory acceptance of alternative methods which are of importance to the biosciences and which reduce, refine or replace the use of laboratory animals. One of the first priorities set by ECVAM was the implementation of procedures that would enable it to become well-informed about the state-of-the-art of non-animal testing in regulatory procedures. It was decided that this would be best achieved by the organisation of ECVAM workshops on specific topics, at which small groups of invited experts would review the current status of in vitro tests and their potential uses, and make recommendations about the best ways forward (1). The number of alternative test methods continues to increase. However, these new methods are not automatically accepted and implemented for use for regulatory purposes. From the experience acquired during the last decade, we know that, after the scientific process of validation, finalised by an ESAC statement, the process of acceptance by regulators often takes a long time. ECVAM therefore held a workshop on Optimisation of the PostValidation Process at Ispra, on 19–22 June 2006. The workshop was chaired by Annamaria A. Bottini and Bas Blaauboer. The principal aim was to identify the factors and key players which influence the execution of the Three Rs in regulatory animal testing, and to provide, where possible, a critical appreciation of how scientists, regulators and legislators could interact to facilitate the promotion of alternative methods and their implementation into regulatory processes in the European Union and, ultimately, throughout the world. This report builds upon the expectations and recommendations of the ECVAM workshop participants on the feasibility of improving the communication among stakeholders and strengthening a Science–Policy Network in the post-validation process.