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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; Pennings, Jeroen; Rigsby, Peter; Riou, Patrice; Balks, Elisabeth; Dobly, Alexandre; Leroy, Odile; Stirling, Catrina.
  • Halder M; European Commission, DG Joint Research Centre, Ispra, Italy. Electronic address: marlies.halder@ec.europa.eu.
  • Depraetere H; European Vaccines Initiative, Heidelberg, Germany. Electronic address: hilde.depraetere@euvaccine.eu.
  • Delannois F; GSK, Rixensart, Belgium. Electronic address: frederique.x.delannois@gsk.com.
  • Akkermans A; National Institute of Public Health and the Environment, Bilthoven, The Netherlands. Electronic address: arnoud.akkermans@rivm.nl.
  • Behr-Gross ME; Council of Europe, European Directorate for the Quality of Medicines & HealthCare, Strasbourg, France. Electronic address: marie-emmanuelle.behr-gross@edqm.eu.
  • Bruysters M; National Institute of Public Health and the Environment, Bilthoven, The Netherlands. Electronic address: martijn.bruysters@rivm.nl.
  • Dierick JF; GSK, Rixensart, Belgium. Electronic address: jean-francois.m.dierick@gsk.com.
  • Jungbäck C; IABS-EU, Lyon, France. Electronic address: carmen.jungbaeck@iabs.org.
  • Kross I; Intervet International BV, Boxmeer, The Netherlands. Electronic address: imke.kross@merck.com.
  • Metz B; Intravacc, Bilthoven, The Netherlands. Electronic address: bernard.metz@intravacc.nl.
  • Pennings J; National Institute of Public Health and the Environment, Bilthoven, The Netherlands. Electronic address: jeroen.pennings@rivm.nl.
  • Rigsby P; National Institute for Biological Standards and Control, Potters Bar, UK. Electronic address: peter.rigsby@nibsc.org.
  • Riou P; Sanofi Pasteur, Lyon, France. Electronic address: patrice.riou@sanofi.com.
  • Balks E; Paul Ehrlich Institut, Langen, Germany. Electronic address: elisabeth.balks@pei.de.
  • Dobly A; Scientific Institute of Public Health, Brussels, Belgium. Electronic address: Alexandre.Dobly@wiv-isp.be.
  • Leroy O; European Vaccines Initiative, Heidelberg, Germany. Electronic address: odile.leroy@euvaccine.eu.
  • Stirling C; Zoetis, UK. Electronic address: catrina.stirling@zoetis.com.
Biologicals ; 52: 78-82, 2018 Mar.
Article en En | MEDLINE | ID: mdl-29395838
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.
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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Conferencias de Consenso como Asunto / Vacunas / Estudios Multicéntricos como Asunto / Guías de Práctica Clínica como Asunto / Estudios de Validación como Asunto Tipo de estudio: Clinical_trials / Guideline Límite: Humans Idioma: En Año: 2018 Tipo del documento: Article
Texto completo
Imprimir
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PubMed Links
Search on Google

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Conferencias de Consenso como Asunto / Vacunas / Estudios Multicéntricos como Asunto / Guías de Práctica Clínica como Asunto / Estudios de Validación como Asunto Tipo de estudio: Clinical_trials / Guideline Límite: Humans Idioma: En Año: 2018 Tipo del documento: Article