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WorkingGroup/GLP Analytics
The working group "analytics" has currently 57 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 at the DGGF member only area.
The next meeting for discussing questions on analytics conducted in a GXP regulated test facility / test site is scheduled on Wednesday 27, June 2012 at Boehringer Ingelheim in Biberach, Germany.
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 will be presented on the member only area.
A further workshop is planed to discuss the "EMA Reflection paper on guidance for laboratories that perform analysis or evaluation of clinical trial samples".
A date and a place is not finaly scheduled at the present moment.
Within the DGGF Annual Meeting from September 20 to 21, 2012 in Dresden, Germany an "Analytic Session" is scheduled 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.
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
Working Group "GLP Analytics"
Welcome to the "GLP Analytics" Working Group:
The working group "analytics" has currently 57 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 at the DGGF member only area.
The next meeting for discussing questions on analytics conducted in a GXP regulated test facility / test site is scheduled on Wednesday 27, June 2012 at Boehringer Ingelheim in Biberach, Germany.
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 will be presented on the member only area.
A further workshop is planed to discuss the "EMA Reflection paper on guidance for laboratories that perform analysis or evaluation of clinical trial samples".
A date and a place is not finaly scheduled at the present moment.
Within the DGGF Annual Meeting from September 20 to 21, 2012 in Dresden, Germany an "Analytic Session" is scheduled 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.
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
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DGGF Flyer 04/2012
