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International DGGF Meeting 2012
Next Meeting will be 20 - 21st September 2012 at Maritin Hotel and International Congress Center Dresden. More details will be on web in April 2012
DGGF comment submitted to EMA:
The DGGF GCP Working Group „Clinical Operations“ headed by Christiane Hartlieb-Wallthor-Sano and supported by PD Dr. Stephan Wnendt (Managing Director MLM Medical Labs, Mönchengladbach GmbH) has submitted a DGGF comment to EMA to the „Reflection paper on guidance for laboratories that perform the analysis or evaluation of clinical trial samples“ (EMA/INS/GCP 532137-2010).
DGGF comments on the planned update of FDA GLPs:
Headed by Ulrich Schepers, DGGF Program coordinator GLP, Head of Global Process & Quality Assurance of BASF DGGF comments on FDA GLP Amendment Docket No. FDA-2010-N-0548), a planned revision of FDA´s “Good Laboratory Practice for Nonclinical Laboratory Studies“ was created and submitted to FDA on 16 February 2011.
GCP Auditing - Methods and Experiences
2nd, revised and expanded edition

Published in August 2007
Presented by the German Society
for Good Research Practice (DGGF e.V.)
2007. Size 147 x 210 mm,
approx. 190 pages, paperback
ISBN 978-3-87193-356-1
69,00 EUR
Click here to download a flyer
DGGF members could order one copy for a special price (approx 50 EUR) as long as these cheaper copies are available. Please send your order to mv@dggf.de
President
Steffen König
eMail: Steffen.Koenig@ISTgmbh.com
Treasurer
Christiane Hartlieb-Wallthor-Sano
eMail: hartlieb@pro-ts.com
weiter
Welcome at the Internetpages of the "German Society for Good Research Practice" (DGGF e.V.)
The term "Good Research Practices" is used to describe a mixture of legal requirements and voluntary measures taken by those involved in research and development studies with chemical products (particularly, but not only, pharmaceutical products and agrochemical products) to ensure that the studies are planned, performed, evaluated, reported and archived in a reliable
and transparent way. This is done so that decisions taken based on the reports of these studies are soundly based and of high scientific quality. The term thus covers "Good Laboratory Practices" (GLP), "Good Clinical Practices" (GCP), "Good Manufacturing Practices" (GMP) and other related Good Practices (GxP).
Our websites inform you about all the important issues about our aims, our organization and activities. If you see a "German flag" in the left row, you will find only german text at the moment - otherwise you will find the information in English.
Some websites are only for DGGF members and will not be translated.
and transparent way. This is done so that decisions taken based on the reports of these studies are soundly based and of high scientific quality. The term thus covers "Good Laboratory Practices" (GLP), "Good Clinical Practices" (GCP), "Good Manufacturing Practices" (GMP) and other related Good Practices (GxP).
Our websites inform you about all the important issues about our aims, our organization and activities. If you see a "German flag" in the left row, you will find only german text at the moment - otherwise you will find the information in English.
Some websites are only for DGGF members and will not be translated.
Current informations
International DGGF Meeting 2012
Next Meeting will be 20 - 21st September 2012 at Maritin Hotel and International Congress Center Dresden. More details will be on web in April 2012
DGGF comment submitted to EMA:
The DGGF GCP Working Group „Clinical Operations“ headed by Christiane Hartlieb-Wallthor-Sano and supported by PD Dr. Stephan Wnendt (Managing Director MLM Medical Labs, Mönchengladbach GmbH) has submitted a DGGF comment to EMA to the „Reflection paper on guidance for laboratories that perform the analysis or evaluation of clinical trial samples“ (EMA/INS/GCP 532137-2010).
DGGF comments on the planned update of FDA GLPs:
Headed by Ulrich Schepers, DGGF Program coordinator GLP, Head of Global Process & Quality Assurance of BASF DGGF comments on FDA GLP Amendment Docket No. FDA-2010-N-0548), a planned revision of FDA´s “Good Laboratory Practice for Nonclinical Laboratory Studies“ was created and submitted to FDA on 16 February 2011.
GCP Auditing - Methods and Experiences
2nd, revised and expanded edition
Published in August 2007
Presented by the German Society
for Good Research Practice (DGGF e.V.)
2007. Size 147 x 210 mm,
approx. 190 pages, paperback
ISBN 978-3-87193-356-1
69,00 EUR
Click here to download a flyer
DGGF members could order one copy for a special price (approx 50 EUR) as long as these cheaper copies are available. Please send your order to mv@dggf.de
Board
weiter
Working groups
Purpose of the Working Groups
" The practical achievement of the society objectives in the different areas of interest will come from the efforts of the working groups, which are founded during the membership meetings" (Quotation of the constitution of the society).
weiter
" The practical achievement of the society objectives in the different areas of interest will come from the efforts of the working groups, which are founded during the membership meetings" (Quotation of the constitution of the society).
