Privatsphäre-Einstellungen

GCP-Inspektionen in Deutschland und Europa nach Implementierung der Direktive 2001/20/EG

Teil 2: Ergebnisse einer Umfrage bei Mitgliedsfirmen des Verbandes Forschender Arzneimittelhersteller e.V. (VFA)*)

Dr. Dieter Baier¹, Dr. Claus Göbel², Dr. Heiner Gertzen³, Dr. Birgit Ruhfus⁴, Per-Holger Sanden⁵, Dr. Jürgen-Hans Schmidt⁶ und Dr. Dorette Schrag-Floß⁷

Roche Pharma AG¹, Grenzach-Wyhlen, Pfizer Pharma GmbH², Karlsruhe, Sanofi-Aventis Pharma S. A.³, Paris, Bayer Schering Pharma AG⁴, Berlin, Merck Serono International SA⁵, Darmstadt, Sanofi-Aventis Pharma Deutschland⁶, Bad Soden, CSL Behring GmbH⁷, Marburg

Inspections of clinical trials by competent authorities are not only a check of the appropriate conduct, but also an active contribution to the interpretation and understanding of the GCP guideline. The variability of discretion is considerable and should be questioned and made transparent. For this reason a working group of the German Association of Research-Based Pharmaceutical Companies (VFA, � Verband Forschender Arzneimittelhersteller e.V., Berlin) “(sub-committee “Clinical Research / Quality Assurance”) performed a survey on the frequency, type, reasons and findings of GCP inspections at the sponsors’ and investigational sites in Germany and Europe during the period of January 2005 to May 2007 within the members of VFA. The results show a rather constant inspection activity of competent authorities in Germany as well as Europe. As expected, the most frequent type of inspection is that at the investigational site (94 % in Germany and 70 % in Europe except Germany), which is – for Germany – understood as a consequence of its federal structure. Within no other European country so many authorities are involved as in Germany, a fact which calls for harmonization of the inspection routines. The GCP inspection activity differs significantly between authorities. The contents of the inspection findings correspond to those of sponsor-initiated audits and underline the necessity of constant attention to persistent sources of deviations.