Recommendations of the VAC2VAC workshop on the design of multi-centre validation studies

Abstract

Within the Innovative Medicines Initiative 2 (IMI 2) project VAC2VAC (Vaccine batch to vaccine batch comparison by consistency testing), a workshop has been organised to discuss ways of improving the design of multi-centre validation studies and use the data generated for product-specific validation purposes. Moreover, aspects of validation within the consistency approach context were addressed. This report summarises the discussions and outlines the conclusions and recommendations agreed on by the workshop participants.

Keywords: 3R principles; Biological Standardisation Programme; Consistency approach; Implementation of non-animal methods; Regulatory acceptance; Vaccine quality control; Validation.