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Biologicals. 2018 Mar;52:78-82. doi: 10.1016/j.biologicals.2018.01.003. Epub 2018 Feb 1.

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

Author information

1
European Commission, DG Joint Research Centre, Ispra, Italy. Electronic address: marlies.halder@ec.europa.eu.
2
European Vaccines Initiative, Heidelberg, Germany. Electronic address: hilde.depraetere@euvaccine.eu.
3
GSK, Rixensart, Belgium. Electronic address: frederique.x.delannois@gsk.com.
4
National Institute of Public Health and the Environment, Bilthoven, The Netherlands. Electronic address: arnoud.akkermans@rivm.nl.
5
Council of Europe, European Directorate for the Quality of Medicines & HealthCare, Strasbourg, France. Electronic address: marie-emmanuelle.behr-gross@edqm.eu.
6
National Institute of Public Health and the Environment, Bilthoven, The Netherlands. Electronic address: martijn.bruysters@rivm.nl.
7
GSK, Rixensart, Belgium. Electronic address: jean-francois.m.dierick@gsk.com.
8
IABS-EU, Lyon, France. Electronic address: carmen.jungbaeck@iabs.org.
9
Intervet International BV, Boxmeer, The Netherlands. Electronic address: imke.kross@merck.com.
10
Intravacc, Bilthoven, The Netherlands. Electronic address: bernard.metz@intravacc.nl.
11
National Institute of Public Health and the Environment, Bilthoven, The Netherlands. Electronic address: jeroen.pennings@rivm.nl.
12
National Institute for Biological Standards and Control, Potters Bar, UK. Electronic address: peter.rigsby@nibsc.org.
13
Sanofi Pasteur, Lyon, France. Electronic address: patrice.riou@sanofi.com.
14
Paul Ehrlich Institut, Langen, Germany. Electronic address: elisabeth.balks@pei.de.
15
Scientific Institute of Public Health, Brussels, Belgium. Electronic address: Alexandre.Dobly@wiv-isp.be.
16
European Vaccines Initiative, Heidelberg, Germany. Electronic address: odile.leroy@euvaccine.eu.
17
Zoetis, UK. Electronic address: catrina.stirling@zoetis.com.

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

PMID:
29395838
PMCID:
PMC6278876
DOI:
10.1016/j.biologicals.2018.01.003
[Indexed for MEDLINE]
Free PMC Article

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