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- Published online May 26, 2014.
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© PDA, Inc. 2014
Author Information
- Hannelore Willkommena,*,
- Johannes Blümelb,
- Kurt Brorsonc,
- Dayue Chend,
- Qi Chene,
- Albrecht Grönerf,
- Brian R. Hubbardg,
- Thomas R. Kreilh,
- Michael Ruffingi,
- Sol Ruizj,
- Dorothy Scottk and
- Glenda Silvesterl
- aRegulatory Affairs & Biological Safety Consulting, Erzhausen, Germany;
- bPaul-Ehrlich-Institut, Langen, Germany;
- cCDER/FDA, Silver Spring MD, USA;
- dGenentech Inc., South San Francisco, CA, USA;
- eEli Lilly and Company, Indianapolis, IN, USA;
- fCSL Behring GmbH, Marburg, Germany;
- gAmgen Inc., Thousand Oaks, CA, USA;
- hBaxter BioScience, Vienna, Austria;
- iBoehringer Ingelheim Pharma GmbH&KG, Bieberach an der Riss, Germany;
- jSpanish Medicines Agency (AEMPS), Madrid, Spain;
- kCBER/FDA, Silver Spring MD, USA;
- lEuropean Medicines Agency, London, UK
- ↵* Corresponding Author: Hannelore Willkommen, Regulatory Affairs and Biological Safety Consulting, 64390 Erzhausen, Germany; phone: +49-6150 867867; hannelore.willkommen{at}gmx.de
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