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Validation of Alternative Methods for the Potency Testing of Vaccines The Report and Recommendations of ECVAM Workshop 31

Coenraad Hendriksen, Jean-Marc Spieser, Arnoud Akkermans, Michael Balls, Lukas Bruckner, Klaus Cussler, Arnold Daas, Johan Descamps, Roland Dobbelaer, Julia Fentem, Marlies Halder, Margot van der Kamp, Roger Lucken, Julie Milstien, Dorothea Sesardic, Donald Straughan and Antonio Valadares

This is the report of the thirty-first of a series of workshops organised by the European Centre for the Validation of Alternative Methods (ECVAM). The specific aims of the workshop were: a) to discuss existing guidelines for validation; b) to explore specific guidelines for the validation of alternative methods for the potency testing of vaccines, and to agree on strategies for the preparation of such guidelines; and c) to discuss the implementation of validated alternative methods in a regulatory context. The outcome of the discussions and the recommendations agreed by the workshop participants are summarised in this report.