The presentation will provide an overview of ECVAM's role and tasks particularly in the light of the new Directive 2010/63/EU on the protection of animals used for scientific purposes and the key changes to improve and accelerate the process of scientific validation of alternative approaches.
Directive 2010/63/EU revises Directive 86/609 and formally establishes the Union Reference Laboratory for alternative methods to animal testing (ECVAM). The duties and tasks for the reference laboratory, as given in Annex VII to the Directive, are in line with the traditional work of ECVAM, with an additional requirement to promote the development and use of alternative procedures in the areas of basic and applied research.
The Directive calls for Member States (MS) to nominate a single point of contact to provide advice on the regulatory relevance and suitability of alternative approaches proposed for validation. In addition, MS are invited to identify laboratories qualified to carry out validation studies. In line with these requests, the PARERE (Preliminary Assessment of Regulatory relevance) network has been established to advise ECVAM on the regulatory relevance of alternative test methods submitted for validation. ECVAM is also setting up a network of laboratories in the MS that could participate to validation studies (NETVAL). The dialogue with the stakeholder community, also a task of the reference laboratory, is maintained by the ECVAM stakeholder forum (ESTAF).
The current work of ECVAM can be grouped in three main pillars relating to validation, innovation and communication. With respect to validation, the main role is the coordination of validation studies at European level and of the independent peer review of validation studies. The latter is done by the ECVAM Scientific Advisory Committee (ESAC). Before, during and after validationECVAM maintains dialogue with stakeholders and experts. In addition, the collaboration with validation bodies from US, Japan, Canada and South Korea is done within the context of the International Cooperation on Alternative Methods (ICATM) framework, with a clear goal towards working more efficiently and effectively and speeding up the regulatory acceptance of new test methods at OECD level. Under innovation the development and optimisation of methods is included. The works adopts a multi-disciplinary approach combining in vitro, in silico andomics approaches, and focuses on improved mechanistic understanding (biological relevance) to address complex endpoints. High-throughput platforms for testing and validation purposes are also used. Communication promotes the use of alternative methods through their dissemination via the DB-ALM database, by providing a tracking tool on the progress of alternative methods through test submission to regulatory acceptance (called "TSAR") and by promoting dialogue with all relevant stakeholders. DB-ALM and the recently finalised "Search Guide" should also help interested parties (e.g. researchers and national committees) to verify if alternatives to a planned animal test exist, e.g. as required by Directive 2010/63 (Annex VI) as part of the project authorisation and evaluation process.