Scientific Advice with the Authorisation Agency for Therapeutic Products of Switzerland – Swissmedic

The TargetAMD consortium sought a scientific advice with the regulatory authority of Switzerland – Swissmedic – with regard to the clinical trial in Switzerland. Both clinical trials, performed in Switzerland and Austria, will focus on safety. Further project progress and study design will be discussed in close cooperation with Swissmedic. The regulatory authority recommended a close cooperation during approval phase due to the project´s innovative purpose. In Europe it will be the first time that the Sleeping Beauty transposon system is going into the clinic and the extraordinary procedure of biopsy, transfection and re-transplantation in one surgical session is pioneering.

16. April 2014
Categories: Target AMD