GCP inspections in Germany and Europe following the implementation of the Directive 2001/20/EC

Background: The implementation of the Clinical Trials Directive 2001/20/EC and the Good Clinical Practice Directive 2005/28/EC fundamentally restructured and harmonized the conduct of clinical trials in Europe. GCP inspections – which affect study sites, laboratories, sponsors and contract research...

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Hlavní autoři:	Hundt, Ferdinand, Ruhfus, Birgit, Baier, Dieter, Göbel, Claus
Médium:	Artigo
Jazyk:	Alemão
Vydáno:	German Medical Science GMS Publishing House 2009-03-01
Edice:	GMS German Medical Science
Témata:	GCP inspection Implementation Directive 2001/20/EC frequency survey sponsor inspection code of practice
On-line přístup:	http://www.egms.de/en/gms/2009-7/000060.shtml
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