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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Detalles Bibliográficos
Autores principales: Göbel, Claus, Baier, Dieter, Ruhfus, Birgit, Hundt, Ferdinand
Formato: Texto
Lenguaje:English
Publicado: German Medical Science GMS Publishing House 2009
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2716552/
https://www.ncbi.nlm.nih.gov/pubmed/19675741
http://dx.doi.org/10.3205/000060

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2716552/
https://www.ncbi.nlm.nih.gov/pubmed/19675741
http://dx.doi.org/10.3205/000060

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