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- Published online April 8, 2013.
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© PDA, Inc. 2013
Author Information
- Hannelore Willkommena,*,
- Johannes BlüMelb,
- Kurt Brorsonc,
- Dayue Chend,
- Qi Chene,
- Albrecht GröNerf,
- Thomas R. Kreilg,
- James S. Robertsonh,
- Michael Ruffingi and
- Sol Ruizj
- aRegulatory Affairs & Biological Safety Consulting, Erzhausen, Germany;
- bPaul-Ehrlich Institut, Langen, Germany;
- cCenter for Drug Evaluation and Research (CDER)/U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA;
- dEli Lilly and Company, Indianapolis, IN, USA;
- eGenentech Inc., South San Francisco, CA, USA;
- fCSL Behring GmbH, Marburg, Germany;
- gBaxter BioScience, Vienna, Austria;
- hBoehringer Ingelheim Pharma GmbH&KG, Bieberach an der Riss, Germany;
- iNational Institute for Biological Standards and Control, Potters Bar, UK; and
- jSpanish Medicines Agency (AEMPS), Madrid, Spain
- ↵* Correspondence 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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