GLP Analytics
The working group "analytics" has currently 59 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 results of the working group meetings will be published on the DGGF member only area and in the DGGF NEWS.
The last meeting for discussing questions on analytics conducted in a GXP regulated test facility / test site took place on Wednesday 27, June 2012 at Boehringer Ingelheim in Biberach, Germany. The result was published on the member only area and in the DGGF NEWS.
A new meeting in 2013 is scheduled on September 05, 2013 at BSAF SE in Ludwigshafen.
On March 07, 2012 a workshop took place at Sanofi in Frankfurt, Germany to discuss the "EMA Guideline on bioanalytical method validation" . The result and a recommendation was published on the member only area and in the DGGF NEWS.
On August 27, 2012 a workshop took place at Sanofi in Frankfurt, Germany to discuss the "EMA Reflection paper on guidance for laboratories that perform the analysis or evaluation of clinical trial samples".
The result of the discussion was published on the member only area and in the DGGF NEWS.
Within the DGGF Annual Meeting from September 20 to 21, 2012 in Dresden, Germany an "Analytic Session" took place with topics as follows:
"Calibration-free concentration analysis for immunogenecity testing employing Biacore", Karin Benstein, Sanofi, Frankfurt, Germany.
"ISR and internal standard issues within a bioanalytical lab", Ronald Schmidt, Sanofi, Frankfurt, Germany.
"Kinderkrankheiten bei der Umsetzung der EMA Guideline on bioanalytical method validation", Timo Kretschmar, pharm-analyt, Baden, Austria.
A summary of the lectures was published in the DGGF NEWS (no. 63, December 2013).
Instead of a DGGF Annual Meeting an European QA Conference take place from September 25 to 27, 2013 in Bonn, Hotel Maritim. The present program of the conference is available on the DGGF Homepage (Meeting &Events / European QA Conference).
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
Welcome to the "GLP Analytics" Working Group:
The working group "analytics" has currently 59 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 results of the working group meetings will be published on the DGGF member only area and in the DGGF NEWS.
The last meeting for discussing questions on analytics conducted in a GXP regulated test facility / test site took place on Wednesday 27, June 2012 at Boehringer Ingelheim in Biberach, Germany. The result was published on the member only area and in the DGGF NEWS.
A new meeting in 2013 is scheduled on September 05, 2013 at BSAF SE in Ludwigshafen.
On March 07, 2012 a workshop took place at Sanofi in Frankfurt, Germany to discuss the "EMA Guideline on bioanalytical method validation" . The result and a recommendation was published on the member only area and in the DGGF NEWS.
On August 27, 2012 a workshop took place at Sanofi in Frankfurt, Germany to discuss the "EMA Reflection paper on guidance for laboratories that perform the analysis or evaluation of clinical trial samples".
The result of the discussion was published on the member only area and in the DGGF NEWS.
Within the DGGF Annual Meeting from September 20 to 21, 2012 in Dresden, Germany an "Analytic Session" took place with topics as follows:
"Calibration-free concentration analysis for immunogenecity testing employing Biacore", Karin Benstein, Sanofi, Frankfurt, Germany.
"ISR and internal standard issues within a bioanalytical lab", Ronald Schmidt, Sanofi, Frankfurt, Germany.
"Kinderkrankheiten bei der Umsetzung der EMA Guideline on bioanalytical method validation", Timo Kretschmar, pharm-analyt, Baden, Austria.
A summary of the lectures was published in the DGGF NEWS (no. 63, December 2013).
Instead of a DGGF Annual Meeting an European QA Conference take place from September 25 to 27, 2013 in Bonn, Hotel Maritim. The present program of the conference is available on the DGGF Homepage (Meeting &Events / European QA Conference).
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
