Beruflich Dokumente
Kultur Dokumente
REGULATORY MANAGER
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5.
6.
7.
8.
9.
10.
11.
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consleg/2006/R/02006R1901-20070126-en.pdf.
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2.
Regulation (EC) No 1901-2006, op.cit. Article 2, Paragraph
1.
ICH Harmonised Tripartite Guideline:Clinical Investigation
of Medicinal Products in the Paediatric Population E11.
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http://www.ich.org/LOB/media/MEDIA487.pdf.
Accessed 12 October 2010.
Paediatric Committee (PDCO). European Medicines
Agency website. http://www.ema.europa.eu/ema/
index.jsp?curl=pages/about_us/general/general_content_000265.jsp&murl=menus/about_us/about_us.jsp&
mid=WC0b01ac0580028e9d&jsenabled=true. Accessed 12
October 2010.
European Medicines Agency public website for posting
of decisions on PIPs. http://www.ema.europa.eu/ema/
index.jsp?curl=pages/medicines/landing/pip_search.
jsp&murl=menus/medicines/medicines.jsp&mid=WC0b0
1ac058001d129&jsenabled=true. Accessed 12 October 2010.
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Regulatory Focus
43
Authors
Raj Kishore, PhD, is senior director of regulatory affairs at
Quintiles. He has more than 20 years of regulatory experience
at FDAs Center for Drug Evaluation and Research and in the
pharmaceutical industry. He can be reached at raj.kishore@
quintiles.com. Edward Tabor, MD, is vice president and global
head of regulatory strategy at Quintiles. He was formerly an
FDA division director in both the Center for Drug Evaluation
and Research and the Center for Biologics Evaluation and
Research. He can be reached at edward.tabor@quintiles.com.
2010 by the Regulatory Affairs Professionals Society (RAPS).
Reprinted from the November 2010 issue of Regulatory Focus
with the permission of RAPS.
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