Recommendations of the VAC2VAC workshop on the design of multi-centre validation studies.
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.
['Halder|Marlies|M|', 'Depraetere|Hilde|H|', 'Delannois|Frédérique|F|', 'Akkermans|Arnoud|A|', 'Behr-Gross|Marie-Emmanuelle|ME|', 'Bruysters|Martijn|M|', 'Dierick|Jean-François|JF|', 'Jungbäck|Carmen|C|', 'Kross|Imke|I|', 'Metz|Bernard|B|', 'Pennings|Jeroen|J|', 'Rigsby|Peter|P|', 'Riou|Patrice|P|', 'Balks|Elisabeth|E|', 'Dobly|Alexandre|A|', 'Leroy|Odile|O|', 'Stirling|Catrina|C|']
D003245:Consensus Development Conferences as Topic D006801:Humans D015337:Multicenter Studies as Topic D017410:Practice Guidelines as Topic D014612:Vaccines D054928:Validation Studies as Topic
Validation Consistency approach 3R principles Biological Standardisation Programme Implementation of non-animal methods Regulatory acceptance Vaccine quality control