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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...
| Autores principales: | , , , |
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| Formato: | Texto |
| Lenguaje: | English |
| Publicado: |
German Medical Science GMS Publishing House
2009
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| Materias: | |
| 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 |