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GLP Analytics

Welcome to the "GLP Analytics" Working Group:

The working group "analytics" has currently 62 participants of research and development mainly pharmaceutical, agricultural and chemical industry as well as contract research organization.
The working group is concerned with all questions on analytics which can occur within the range of the GxP-regulated test facilities / test sites.
A goal of the working group is a regular exchange of information and experience with mainly concerned Good Laboratory Practice.
The working group meets at least once a year in order to work on current topics by presentations and discussions.

The last meeting took place on March 18, 2016 at Bayer Pharma AG in Wuppertal, Germany
The next meeting for discussing questions on analytics conducted in a GXP regulated test facility / test site take place on 12-Sep-2017 at Sanofi-Aventis deutschland GmbH in Frankfurt am Main, Germany.

The results of the working group meetings will be published on the DGGF member only area and in the GQMA NEWS.

Members of the GQMA has also the possibility to discuss questions in the "Forum" at the member only area of the GQMA website.

The last GQMA International Meeting took place from 22. to 23. September 2016 at Maritim Hotel in Bonn (Germany).
Presentations concerning analytics were presented in "Stream GLP 1" (22-09-2016, 2:00 pm - 3:30 pm) and "Stream GLP 3" (23-09-2016, 9:00 am - 10:30 am).
The final program is available on the GQMA website.
The next GQMA International Meeting take place from 21. to 22. September 2017 at Maritim Hotel in W├╝rzburg (Germany)
Presentations concerning analytics will be presented in "Session Analytic_1" (21-09-2017, 2:00 pm - 3.30 pm) and in "Session GLP_2" (22-09-2017: 9:00 am - 9:45 am).


If you have questions about the work of this working group, please contact the working goup leader:

Andreas Henrichs
Tel.: +49 (0)69 305 24141
Sanofi-Aventis Deutschland GmbH
email: andreas.henrichs@sanofi.com

For this workgroup, you can access information only on the German side:
  • Analytical Instrument Qualification - Validation versus Qualification
  • Zusammenfassung der Diskussion - Validierung von bioanalytischen Methoden als Kurzzeitpr├╝fung
  • Recommendations and Interpretations EMA guideline on Bioanalytical Method Validation
  • Protokolle Arbeitsgruppe Analytik von 1996 bis 1999
  • _______________________________________________________________
  • Protokoll vom 18.03.2016
  • Protokoll vom 20. Juni 2015
  • Protokoll vom 06. Juni 2014
  • Protokoll vom 05. September 2013
  • Protokoll zum Workshop Interpretation EMA Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples
  • Protokoll zum Workshop Interpretation EMA Guideline on bioanalytical method validation
  • Protokoll vom 27. Juni 2012
  • Protokoll vom 10. August 2011
  • Protokoll vom 07. Juli 2010
  • Protokoll vom 04. Juni 2009
  • Protokoll vom 17 November 2008
  • Protokoll vom 03. Juli 2007
  • Protokoll vom 06. Juni 2006
  • Protokoll vom 12. Mai 2005
  • Protokoll vom 15. Juni 2004
  • Protokoll vom 04. Juni 2003
  • Protokoll vom 18. Juni 2002
  • Protokoll vom 22. Juni 2001
  • Protokoll vom 06. Juni 2000
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