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

Marlies Halder,Hilde Depraetere,Frédérique Delannois,Arnoud Akkermans,Marie-Emmanuelle Behr-Gross,Martijn Bruysters,Jean-François Dierick,Carmen Jungbäck,Imke Kross,Bernard Metz,Jeroen Pennings,Peter Rigsby,Patrice Riou,Elisabeth Balks,Alexandre Dobly,Odile Leroy,Catrina Stirling

Biologicals（2018）

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摘要

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.

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关键词

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

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