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Regulatory workshop on challenge strain development and GMP manufacture - A stakeholder meeting report.

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Title: Regulatory workshop on challenge strain development and GMP manufacture - A stakeholder meeting report.
Authors: Corti N; European Vaccine Initiative (EVI), Heidelberg, Germany., Chiu C; Imperial College London (ICL), London, United Kingdom., Cox RJ; University of Bergen, Bergen, Norway., Demont C; Sanofi Pasteur, Lyon, France., Devaster JM; GlaxoSmithKline Biologicals S.A., Rixensart, Belgium., Engelhardt OG; The Medicines and Healthcare products Regulatory Agency (MHRA), London, United Kingdom., Gorringe A; UK Health Security Agency (UKHSA), London, United Kingdom., Hassan K; GlaxoSmithKline Biologicals S.A., Rixensart, Belgium., Hoefnagel M; Medicines Evaluation Board (MEB), Utrecht, the Netherlands., Kamerling I; Centre for Human Drug Research, Leiden, the Netherlands., Krut O; Paul-Ehrlich-Institut (PEI), Langen, Germany., Lane C; National Institutes of Health (NIH/NIAID), Maryland, United States., Liebers R; European Vaccine Initiative (EVI), Heidelberg, Germany., Luke C; National Institutes of Health (NIH/NIAID), Maryland, United States., Van Molle W; Sciensano, Brussels, Belgium., Morel S; GlaxoSmithKline Biologicals S.A., Rixensart, Belgium., Neels P; International Alliance of Biological Standardization (IABS-EU), Geneva, Switzerland., Roestenberg M; Leiden University Medical Center (LUMC), Leiden, the Netherlands., Rubbrecht M; P95 Epidemiology & Pharmacovigilance, Leuven, Belgium., Klaas Smits W; Leiden University Medical Center (LUMC), Leiden, the Netherlands., Stoughton D; National Institutes of Health (NIH/NIAID), Maryland, United States., Talaat K; Johns Hopkins Bloomberg School of Public Health, Maryland, United States., Vehreschild MJGT; Department of Internal Medicine, Division of Infectious Diseases, Faculty of Medicine and University Hospital Cologne, University of Cologne, German Centre for Infection Research (DZIF), Site Bonn-Cologne, Cologne, Germany., Wildfire A; CHIMunomics, Horsell, United Kingdom., Meln I; European Vaccine Initiative (EVI), Heidelberg, Germany., Olesen OF; European Vaccine Initiative (EVI), Heidelberg, Germany. Electronic address: ole.olesen@euvaccine.eu.
Source: Biologicals : journal of the International Association of Biological Standardization [Biologicals] 2024 Feb; Vol. 85, pp. 101746. Date of Electronic Publication: 2024 Feb 03.
Publication Type: Conference Proceedings
Journal Info: Publisher: Academic Press Country of Publication: England NLM ID: 9004494 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1095-8320 (Electronic) Linking ISSN: 10451056 NLM ISO Abbreviation: Biologicals Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Regulatory workshop on challenge strain development and GMP manufacture - A stakeholder meeting report.
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  Data: <searchLink fieldCode="AU" term="%22Corti+N%22">Corti N</searchLink>; European Vaccine Initiative (EVI), Heidelberg, Germany.<br /><searchLink fieldCode="AU" term="%22Chiu+C%22">Chiu C</searchLink>; Imperial College London (ICL), London, United Kingdom.<br /><searchLink fieldCode="AU" term="%22Cox+RJ%22">Cox RJ</searchLink>; University of Bergen, Bergen, Norway.<br /><searchLink fieldCode="AU" term="%22Demont+C%22">Demont C</searchLink>; Sanofi Pasteur, Lyon, France.<br /><searchLink fieldCode="AU" term="%22Devaster+JM%22">Devaster JM</searchLink>; GlaxoSmithKline Biologicals S.A., Rixensart, Belgium.<br /><searchLink fieldCode="AU" term="%22Engelhardt+OG%22">Engelhardt OG</searchLink>; The Medicines and Healthcare products Regulatory Agency (MHRA), London, United Kingdom.<br /><searchLink fieldCode="AU" term="%22Gorringe+A%22">Gorringe A</searchLink>; UK Health Security Agency (UKHSA), London, United Kingdom.<br /><searchLink fieldCode="AU" term="%22Hassan+K%22">Hassan K</searchLink>; GlaxoSmithKline Biologicals S.A., Rixensart, Belgium.<br /><searchLink fieldCode="AU" term="%22Hoefnagel+M%22">Hoefnagel M</searchLink>; Medicines Evaluation Board (MEB), Utrecht, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Kamerling+I%22">Kamerling I</searchLink>; Centre for Human Drug Research, Leiden, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Krut+O%22">Krut O</searchLink>; Paul-Ehrlich-Institut (PEI), Langen, Germany.<br /><searchLink fieldCode="AU" term="%22Lane+C%22">Lane C</searchLink>; National Institutes of Health (NIH/NIAID), Maryland, United States.<br /><searchLink fieldCode="AU" term="%22Liebers+R%22">Liebers R</searchLink>; European Vaccine Initiative (EVI), Heidelberg, Germany.<br /><searchLink fieldCode="AU" term="%22Luke+C%22">Luke C</searchLink>; National Institutes of Health (NIH/NIAID), Maryland, United States.<br /><searchLink fieldCode="AU" term="%22Van+Molle+W%22">Van Molle W</searchLink>; Sciensano, Brussels, Belgium.<br /><searchLink fieldCode="AU" term="%22Morel+S%22">Morel S</searchLink>; GlaxoSmithKline Biologicals S.A., Rixensart, Belgium.<br /><searchLink fieldCode="AU" term="%22Neels+P%22">Neels P</searchLink>; International Alliance of Biological Standardization (IABS-EU), Geneva, Switzerland.<br /><searchLink fieldCode="AU" term="%22Roestenberg+M%22">Roestenberg M</searchLink>; Leiden University Medical Center (LUMC), Leiden, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Rubbrecht+M%22">Rubbrecht M</searchLink>; P95 Epidemiology & Pharmacovigilance, Leuven, Belgium.<br /><searchLink fieldCode="AU" term="%22Klaas+Smits+W%22">Klaas Smits W</searchLink>; Leiden University Medical Center (LUMC), Leiden, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Stoughton+D%22">Stoughton D</searchLink>; National Institutes of Health (NIH/NIAID), Maryland, United States.<br /><searchLink fieldCode="AU" term="%22Talaat+K%22">Talaat K</searchLink>; Johns Hopkins Bloomberg School of Public Health, Maryland, United States.<br /><searchLink fieldCode="AU" term="%22Vehreschild+MJGT%22">Vehreschild MJGT</searchLink>; Department of Internal Medicine, Division of Infectious Diseases, Faculty of Medicine and University Hospital Cologne, University of Cologne, German Centre for Infection Research (DZIF), Site Bonn-Cologne, Cologne, Germany.<br /><searchLink fieldCode="AU" term="%22Wildfire+A%22">Wildfire A</searchLink>; CHIMunomics, Horsell, United Kingdom.<br /><searchLink fieldCode="AU" term="%22Meln+I%22">Meln I</searchLink>; European Vaccine Initiative (EVI), Heidelberg, Germany.<br /><searchLink fieldCode="AU" term="%22Olesen+OF%22">Olesen OF</searchLink>; European Vaccine Initiative (EVI), Heidelberg, Germany. Electronic address: ole.olesen@euvaccine.eu.
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  Data: <searchLink fieldCode="JN" term="%229004494%22">Biologicals : journal of the International Association of Biological Standardization</searchLink> [Biologicals] 2024 Feb; Vol. 85, pp. 101746. <i>Date of Electronic Publication: </i>2024 Feb 03.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Academic+Press%22">Academic Press </searchLink><i>Country of Publication: </i>England <i>NLM ID: </i>9004494 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1095-8320 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2210451056%22">10451056 </searchLink><i>NLM ISO Abbreviation: </i>Biologicals <i>Subsets: </i>MEDLINE
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