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At the RTC we define translation as the whole process from basic research to patient care with therapeutic benefit and which is at the same time economically justifiable. This process includes the pre/non-clinical development of product and application, the product manufacturing, the preparation and conduct of clinical studies, the Market Authorisation and finally, the reimbursement by the compulsory health insurance. Furthermore, therapy vigilance and care research will be included in our work program in the future.

 
 

 

At the RTC, research and development is focusing on the cardiovascular field and subsequently on the implementation in the clinical practice. The therapeutic and diagnostic investigations developed at the RTC fall under the German Medicines Act.
The medicinal products predominantly are classified as “Advanced Therapy Medicinal Products” (ATMP) sometimes applied as combination-products with medical devices.
The RTC translation team coordinates the pre/non-clinical development with regulatory expertise and prepares – together with the clinical team and the responsible scientists – the product- and indication-specific clinical development program. Furthermore,  the team takes care of the study management and is involved in the activities of health care and vigilance. Based on the already existing RTC quality standards the “Good work Practice” (GxP) in lab and clinic is currently being launched under the guidance of the translation management.

Quality assurance and standardization are of importance for the described translation process and accordingly, for the positioning of the RTC as a Reference Center. Our concepts for these issues have been created in close contact with the competent authorities. Our acquired specific know-how regarding the establishment of quality management (QM) in an university environment is being conveyed by us to other interested parties in the frame of presentations, lectures and seminars.

 

 

 

 

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