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

ABSTRACT:

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 organizations (CRO) alike - make up an important part of these regulations. A common understanding of how these regulations apply in daily life is however not always ensured.

Methods

A working group of the Clinical Research/Quality Assurance subcommittee of the German Association of Research-Based Pharmaceutical Companies (VFA) was established to outline the regulatory requirements, the experience gathered with inspections by means of a survey and to set up guidance on how to manag

SUBMITTER: Gobel C 

PROVIDER: S-EPMC2716552 | biostudies-literature | 2009 Mar

REPOSITORIES: biostudies-literature