Project Manager, expert full-service CRO at Winicker Norimed GmbH Medizinische Forschung, Nuremberg, Germany
Katinka has authored conforming standard operating procedures for ISO 14155 and German MPG/ MPKPV/ MPSV and currently works as a project manager for both medical device trials and non-interventional trials. She is involved in lectures on regulatory and legal issues for investigators, sponsors and other expert personnel. Katinka does have experience as a project leader of international multicenter medical device trials at BIOTRONIK SE& Co. KG. She also worked as a clinical research associate, clinical monitor and scientific manager for ANFOMED GmbH in Mohrendorf, Germany and has experience on clinical trials and the regulatory framework for both drugs and medical devices.