SSS has been following the changes in the regulatory environment over the last number of decades and passes on its knowledge in training courses in GCP/AMG and MPG/MDR. We keep pace with the latest regulatory requirements and make this knowledge available to our customers and clinical study teams.
In the context of medicinal drug and medical device studies German ethic committees request the evidence of qualification for principle investigators and all medicalphysicians in a study team working in clinical trials. In early 2019 the Bundesärztekammer has published a new recommendation (DOI: 10.3238/arztbl.2019.Empfehlungen_AMG_MPG_2019) for the ethics committees that depending on the previously acquired experience defines the courses which are needed for investigators. A graphical view is given in the figure on the right.
As a profound basis in conducting clinical trials according to GCP guidelines we offer the courses bellow to anyone working in clinical trials (Study Nurses, Study Coordinators, Clinical Research Associates etc.).