Validation of alternative methods for the potency testing of vaccines
The joint ECVAM/AGAATI workshop on the validation of alternative methods for the potency testing of vaccines was held in Angera, Italy, 14-16 November 1997, under the co-chairmanship of Coenraad Hendriksen (RIVM, the Netherlands) and Jean-Marc Speiser. The participants, all experts in vaccine quality control and/or validation procedures, came from international regulatory or government organizations, national control laboratories and vaccine manufacturers. The principle objective of the workshop was to discuss, in an informal atmosphere, the complex issue of guidelines for the validation of alternative methods for the potency of testing vaccines. The specific aims of he workshop were to discuss: a) existing guidelines for the validation; b) specific guidelines for the validation of alternative methods for the potency testing of vaccines, and to agree on strategies for the preparation of guidelines: and c) 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.
Bibliographic Reference: Article: ATLA (1999)
Record Number: 199910676 / Last updated on: 1999-04-30
Original language: en
Available languages: en