Development and establishment of a quality-framework for the lena project
Conclusion
The consortiums approach enabled the preparation of a comprehensive, reliable GxP compliant quality system within a short timeframe and with the limited resources of a publicly funded project.
1 "GCLP" is used as acronym for a quality system established in compliance with "Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples" (EMA/INS/GCP/532137/2010; 28 February 2012)
The research leading to these results has received funding from the European Union Seventh Framework Programme (FP7/2007–2013) under grant agreement n°602295 (LENA).
Source: Archives of Disease in Childhood - Category: Pediatrics Authors: Ciplea, A. M., Kleine, K., Burckhardt, B. B., Läer, S., Breitkreutz, J., Spatenkova, L., Klingmann, I. Tags: POSTER PRESENTATIONS Source Type: research
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