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GLP-GEP-Field Studies

Welcome to the "GLP/GEP: Field Studies" Working Group:

The working group currently has approximately 25 - 30 members that meet once per year. Various questions and points of view are discussed surrounding the topic of GLP/GEP and field studies. Although this group has been meeting since 1996 (with an initial meeting of 15 participants), there has been no decline in interest over the years The problem of different test sites within a trial has always been a topic for field studies and the OECD Consensus Document No. 6 (The Application of the GLP Principles to Filed Studies) was the "forerunner" of the OECD Consensus Document No. 13 (Multi Site Studies). Nevertheless, the organization, communication, and effects of this "new" document continue to be a very interesting topic and usually form the basis of the lively discussions.

In addition, topics on electronic data acquisition, GEP, archiving, recent authority inspections, and many other interesting topics offer a basis for fruitful discussions.

Members of the GQMA can see minutes of the meetings on these Internet pages. However, do not forget that these can only represent a summary, which cannot show the interesting and helpful details. For this you must become a member of the working group and participate in the meetings regularly.

If you have questions please contact:

Peter Kaluza
Tel.: 06709-911860
Fax: 06709-911859
Kaluza Quality
Am Falltor 7
D-55546 F├╝rfeld
email Kaluza@Kaluza-Quality.de

For this workgroup, you can access information only on the German side:
  • Protokoll AG-Tagung 2017
  • Protokoll AG-Tagung 2016
  • Protokoll AG-Tagung 2015
  • Protokoll AG-Tagung 2014
  • Protokoll AG-Tagung 2013
  • Protokoll AG-Tagung 2012
  • Protokoll AG-Tagung 2011
  • Protokoll AG-Tagung 2010
  • Protokoll AG-Tagung 2009
  • Protokoll AG-Tagung 2008
  • Protokoll AG-Tagung 2007
  • Protokoll AG-Tagung 2006
  • Protokoll AG-Tagung 2005
  • Protokoll AG-Tagung 2004
  • Protokoll AG-Tagung 2003
  • Protokoll AG-Tagung 2001
  • Protokoll AG-Tagung 2000
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