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Recommendations of the VAC2VAC workshop on the design of multi-centre validation studies.
Halder, Marlies Depraetere, Hilde Delannois, Frédérique Akkermans, Arnoud Behr-Gross, Marie-Emmanuelle Bruysters, Martijn Dierick, Jean-François Jungbäck, Carmen Kross, Imke Metz, Bernard
Halder, Marlies
Depraetere, Hilde
Delannois, Frédérique
Akkermans, Arnoud
Behr-Gross, Marie-Emmanuelle
Bruysters, Martijn
Dierick, Jean-François
Jungbäck, Carmen
Kross, Imke
Metz, Bernard
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Series / Report no.
Open Access
Type
Article
Language
en
Date of publication
2018-01-25
Year of publication
Research Projects
Organizational Units
Journal Issue
Title
Recommendations of the VAC2VAC workshop on the design of multi-centre validation studies.
Translated Title
Published in
Biologicals 2018; 52:78-82
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.