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Research ArticleConference Report

Meeting Report: 2013 PDA Virus & TSE Safety Forum

Hannelore Willkommen, Johannes Blümel, Kurt Brorson, Dayue Chen, Qi Chen, Albrecht Gröner, Brian R. Hubbard, Thomas R. Kreil, Michel Ruffing, Sol Ruiz, Dorothy Scott and Glenda Silvester
PDA Journal of Pharmaceutical Science and Technology May 2014, 68 (3) 193-214; DOI: https://doi.org/10.5731/pdajpst.2014.00980
Hannelore Willkommen
aRegulatory Affairs & Biological Safety Consulting, Erzhausen, Germany;
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  • For correspondence: hannelore.willkommen@gmx.de
Johannes Blümel
bPaul-Ehrlich Institut, Langen, Germany;
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Kurt Brorson
cCDER/FDA, Silver Spring, MD, USA;
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Dayue Chen
dEli Lilly and Company, Indianapolis, IN, USA;
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Qi Chen
eGenentech Inc., South San Francisco, CA, USA;
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Albrecht Gröner
fCSL Behring GmbH, Marburg, Germany;
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Brian R. Hubbard
gAmgen Inc., Thousand Oaks, CA, USA;
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Thomas R. Kreil
hBaxter BioScience, Vienna, Austria;
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Michel Ruffing
iBoehringer Ingelheim Pharma GmbH&KG, Bieberach an der Riss, Germany;
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Sol Ruiz
jSpanish Medicines Agency (AEMPS), Madrid, Spain;
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Dorothy Scott
kCBER/FDA, Silver Spring, MD, USA; and
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Glenda Silvester
lEuropean Medicines Agency, London, UK
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 68 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 3
May/June 2014
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Meeting Report: 2013 PDA Virus & TSE Safety Forum
Hannelore Willkommen, Johannes Blümel, Kurt Brorson, Dayue Chen, Qi Chen, Albrecht Gröner, Brian R. Hubbard, Thomas R. Kreil, Michel Ruffing, Sol Ruiz, Dorothy Scott, Glenda Silvester
PDA Journal of Pharmaceutical Science and Technology May 2014, 68 (3) 193-214; DOI: 10.5731/pdajpst.2014.00980

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Meeting Report: 2013 PDA Virus & TSE Safety Forum
Hannelore Willkommen, Johannes Blümel, Kurt Brorson, Dayue Chen, Qi Chen, Albrecht Gröner, Brian R. Hubbard, Thomas R. Kreil, Michel Ruffing, Sol Ruiz, Dorothy Scott, Glenda Silvester
PDA Journal of Pharmaceutical Science and Technology May 2014, 68 (3) 193-214; DOI: 10.5731/pdajpst.2014.00980
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  • Article
    • Abstract
    • 1. Introduction
    • 2. Virus Safety Forum
    • 3. TSE Safety Forum
    • 4. Conclusions and Next Steps
    • Conflict of Interest Declaration
    • Acknowledgements
    • References
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More in this TOC Section

  • Meeting Report: 2015 PDA Virus & TSE Safety Forum
  • Summary of the EMA Joint Regulators/Industry QbD workshop (London, UK; 28–29 January 2014)
  • PDA Single-Use Systems Cross-Organizational Workshop—Meeting Summary, May 14, 2014—PDA Global Headquarters, Bethesda, MD
Show more Conference Report

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Keywords

  • Virus
  • TSE
  • Safety
  • Biotechnology
  • Plasma derivatives
  • Regulatory affairs
  • Virus Clearance

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