Research ArticleConference Report
Meeting Report: 2015 PDA Virus & TSE Safety Forum
Hannelore Willkommen, Johannes Blümel, Kurt Brorson, Dayue Chen, Qi Chen, Albrecht Gröner, Thomas R. Kreil, Michel Ruffing, Sol Ruiz, Dorothy Scott and Glenda Silvester
PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 177-188; DOI: https://doi.org/10.5731/pdajpst.2016.006569
Hannelore Willkommen
aRegulatory Affairs & Biological Safety Consulting, Erzhausen, Germany
Johannes Blümel
bPaul-Ehrlich Institut, Langen, Germany
Kurt Brorson
cCDER/FDA, Silver Spring MD, USA
Dayue Chen
dEli Lilly and Company, Indianapolis, IN, USA
Qi Chen
eGenentech Inc., South San Francisco, CA, USA
Albrecht Gröner
fPathoGuard Consult, Seeheim-Jugenheim, Germany
Thomas R. Kreil
gBaxalta, Vienna, Austria
Michel Ruffing
hBoehringer Ingelheim Pharma GmbH&KG, Bieberach an der Riss, Germany
Sol Ruiz
iSpanish Medicines Agency (AEMPS), Madrid, Spain
Dorothy Scott
jCBER/FDA, Silver Spring MD, USA
Glenda Silvester
kEuropean Medicines Agency, London, UK

References
- 1.↵Workshop on viral safety of plasma-derived medicinal products with respect to hepatitis E virus. 28–29 October 2015, European Medicines Agency, London http://www.ema.europa.eu
- 2.↵EMA/CHMP/BWP/723009/2014: Reflection paper on viral safety of plasma-derived medicinal products with respect to hepatitis E virus. End of consultation (deadline for comments) 30 September 2015 http://www.ema.europa.eu
- 3.↵EMA/CHMP/BWP/548524/2008. Rev 1: Guideline on epidemiological data on blood transmissible infections. End of consultation (deadline for comments) 31 August 2015 http://www.ema.europa.eu
- 4.↵EMA/CHMP/BWP/26802/2012 Guideline on the adventitious agent safety of urine-derived medicinal products. 26 May 2015 http://www.ema.europa.eu
- 5.↵Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC OJ L158 of 27 May 2014, pp 1–76.
- 6.↵EMA/CHMP/BWP/398498/2005 Guideline on virus safety evaluation of biotechnological investigational medicinal products, http://www.ema.europa.eu
- 7.↵
- Ma H.,
- Galvin T. A.,
- Glasner D. R.,
- Shaheduzzaman S.,
- Khan A. S.
- 8.↵
- 9.↵
- 10.↵IDT Biologika GmbH, Dessau-Rosslau Germany, website: http://www.idt-biologika.de/index.php?lang=2.
- 11.↵
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 70, Issue 2
March/April 2016
Meeting Report: 2015 PDA Virus & TSE Safety Forum
Hannelore Willkommen, Johannes Blümel, Kurt Brorson, Dayue Chen, Qi Chen, Albrecht Gröner, Thomas R. Kreil, Michel Ruffing, Sol Ruiz, Dorothy Scott, Glenda Silvester
PDA Journal of Pharmaceutical Science and Technology Mar 2016, 70 (2) 177-188; DOI: 10.5731/pdajpst.2016.006569
Meeting Report: 2015 PDA Virus & TSE Safety Forum
Hannelore Willkommen, Johannes Blümel, Kurt Brorson, Dayue Chen, Qi Chen, Albrecht Gröner, Thomas R. Kreil, Michel Ruffing, Sol Ruiz, Dorothy Scott, Glenda Silvester
PDA Journal of Pharmaceutical Science and Technology Mar 2016, 70 (2) 177-188; DOI: 10.5731/pdajpst.2016.006569
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