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

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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Bibliographic Details
Main Authors: Hundt, Ferdinand, Ruhfus, Birgit, Baier, Dieter, Göbel, Claus
Format: Article
Language:deu
Published: German Medical Science GMS Publishing House 2009-03-01
Series:GMS German Medical Science
Subjects:
GCP inspection
Implementation Directive 2001/20/EC
frequency
survey
sponsor inspection
code of practice
Online Access:http://www.egms.de/en/gms/2009-7/000060.shtml

Internet

http://www.egms.de/en/gms/2009-7/000060.shtml

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