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EURL ECVAM meets with its regulatory advisory network and stakeholder forum

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Jun 07, 2013
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Emphasis on multilateral cooperation for delivering 3Rs solutions

On 4-6 June, in Ispra, the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) hosted a series of meetings with its regulatory advisory network (PARERE) and its stakeholder forum (ESTAF) to discuss progress and cooperation in the development, validation and acceptance of animal-free approaches for regulatory safety assessment and biomedical research.

The PARERE network, established under the pdf icon EU Directive for the Protection of Animals used for Scientific Purposes, provides EURL ECVAM with advice on the relevance of proposed alternative test methods for use in regulatory safety assessment. Discussions centred on the current state-of-play regarding the establishment of the PARERE network in Member States and its important role in helping to shape EURL ECVAM strategy and prioritise actions towards method validation, promotion and acceptance. A one-day workshop was organised with the participation of both PARERE and ESTAF on the theme, "Establishing the Relevance and Ensuring the Acceptance of Alternative Methods for Regulatory Safety Assessment" where topics addressed included an update on the implementation of the recent EURL ECVAM skin sensitisation strategy, current initiatives by agencies and industry in the pharmaceutical sector to qualify methods for use in pre-clinical drug development, how to provide biomedical research scientists with the right information on in vitro methods to encourage their uptake, and what measures could be taken to increase confidence in the data generated by robotic high throughput testing systems to facilitate there use in regularity decision making. The use of predictive computational methods such as QSAR and the value of an Adverse Outcome Pathway (AOP) framework for guiding the development of integrated approaches to testing and assessment were also discussed.

EURL ECVAM also used the occasion to present for the first time its proposed strategy for reduction of animal use in genotoxicity testing. Achieving the strategic aims in the coming years would result in a considerable saving of animals across many industrial sectors. The strategy was well received and the valuable feedback provided by the participants will be incorporated into a final version to be published in the coming months. A number of PARERE and ESTAF members including industry associations, NGOs and regulatory agencies expressed their willingness to actively contribute to its implementation and to cooperate with ECVAM in achieving its goals.

Photo: Cell culture under sterile conditions in the EURL ECVAM microbiology laboratory. Copyright EU 2012. 

See also: Animals Used for Scientific Purposes - Documentation on the website of the EC, Directorate-General for Environment