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European Parliament. _Official J. Eur. Union_ 27, L378/1–19 (2006). Download references AUTHOR INFORMATION AUTHORS AND AFFILIATIONS * Karen B. Goetz, Michael Pfleiderer and Christian K.

Schneider are at the Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany., Karen B Goetz, Michael Pfleiderer & Christian K Schneider * Michael

Pfleiderer is the chairman of the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) Vaccines Working Party (VWP) and the German member of the EMA CHMP

Biologics Working Party (BWP)., Michael Pfleiderer * Christian K. Schneider is also at the Twincore Centre for Experimental and Clinical Infection Research, Hannover, Germany and is a member

of the EMA Committee for Medicinal Products for Human Use (CHMP), and the chairman of the EMA Committee for Advanced Therapies (CAT)., Christian K Schneider Authors * Karen B Goetz View

author publications You can also search for this author inPubMed Google Scholar * Michael Pfleiderer View author publications You can also search for this author inPubMed Google Scholar *

Christian K Schneider View author publications You can also search for this author inPubMed Google Scholar CORRESPONDING AUTHOR Correspondence to Karen B Goetz. ETHICS DECLARATIONS COMPETING

INTERESTS The authors declare no competing financial interests. ADDITIONAL INFORMATION The views expressed in this article are our personal views and may not be understood or quoted as

being made on behalf of the EMA committees or reflecting the position of the EMA committees or one of the CHMP Working Parties. RIGHTS AND PERMISSIONS Reprints and permissions ABOUT THIS

ARTICLE CITE THIS ARTICLE Goetz, K., Pfleiderer, M. & Schneider, C. First-in-human clinical trials with vaccines—what regulators want. _Nat Biotechnol_ 28, 910–916 (2010).

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