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GCP - Clinical studies on human beings according to "Good Clinical Practice"

According to the German Medicines Act (AMG)  the planning, conduction, documentation and reporting of each clinical study has to be in agreement with the requirements of GCP. From the very beginning the RTC has been conducting its stem cell trials in line with the appropriated rules and strictly adheres to the principles of GCP. Within the scope of the monitoring of an ongoing trial an inspection has been performed in summer 2013 by the Federal German Authorities on behalf of the European Union. With  such a “GCP- quality label” both the study center (site) and the translation management team  are well positioned and professionally prepared to prepare and conduct further clinical trials on human beings in the context of novel cell- and gene-therapy approaches as “Investigator Initiated Trials” (IITs) or in collaboration with industrial sponsors as “Company Initiated Trials” (CITs) in the cardiovascular field. At the moment, the RTC is preparing two IITs addressing new questions of indication and application for stem cell-based cardiac therapies also in collaboration with industry partners.

For further information about the  German Medicines Act (AMG) see:

ICH Guideline

RL 2001/83/EC

GCP-Regulations

German Medicines Act (AMG)

 

 

 

Legal The RTC is supported by the BMBF and the State Mecklenburg-Western Pomerania using EU Structural Funds.