AGAATI/ECVAM Workshop on the Validation of Alternative Methods for the Potency Testing of Vaccines.

The workshop on validation of alternative methods for the potency testing of vaccines was organised by ECVAM (European Centre for the Validation of Alternative Methods) and AGAATI (Advisory Group on Alternatives to Animal Testing in Immunobiologicals), and it was held in Angera, Italy, on 14-16 November 1997 under the co-chairmanship of Coenraad Hendriksen (RIVM, Bilthoven, The Netherlands) and Jean-Marc Spieser (EDQM, Strasbourg, France). The 17 participants, all experts in vaccine quality control and/or validation procedures, came from international regulatory bodies and organisations, national control laboratories and vaccine manufacturers. The aim of the workshop was to discuss, in an informal atmosphere, the complex issue of guidelines for the validation of alternative methods to potency testing of vaccines in laboratory animals, in particular: a) to review existing guidelines for validation; b) to discuss specific guidelines for the validation of alternative methods to the potency testing of vaccines and to agree on strategies for the preparation of guidelines; and c) to discuss and make recommendations for the implementation of validated alternative methods for regulatory purposes. The outcome of the discussions and the recommendations will be published in the ECVAM workshop series in ATLA in late 1998.