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- Published online April 13, 2016.
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- previous version (March 28, 2016 - 17:56).
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- Hannelore Willkommena,
- Johannes Blümelb,
- Kurt Brorsonc,*,
- Dayue Chend,
- Qi Chene,
- Albrecht Grönerf,
- Thomas R. Kreilg,
- Michel Ruffingh,
- Sol Ruizi,
- Dorothy Scottj and
- Glenda Silvesterk
- aRegulatory Affairs & Biological Safety Consulting, Erzhausen, Germany
- bPaul-Ehrlich Institut, Langen, Germany
- cCDER/FDA, Silver Spring MD, USA
- dEli Lilly and Company, Indianapolis, IN, USA
- eGenentech Inc., South San Francisco, CA, USA
- fPathoGuard Consult, Seeheim-Jugenheim, Germany
- gBaxalta, Vienna, Austria
- hBoehringer Ingelheim Pharma GmbH&KG, Bieberach an der Riss, Germany
- iSpanish Medicines Agency (AEMPS), Madrid, Spain
- jCBER/FDA, Silver Spring MD, USA
- kEuropean Medicines Agency, London, UK
- ↵* Corresponding Author: Kurt Brorson, CDER/FDA, Silver Spring MD 20993, USA. E-mail: Kurt.Brorson{at}fda.hhs.gov
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