March 4^th – March 6^th 2025, 8.45-15.30.

This 3 day course is intended for academic researchers who are about to conduct a clinical trial with an investigational medicinal product or a medical device. Researchers in the planning phase of their research project will probably benefit the most of the course.
Focus will be on the practical aspects of how to comply with relevant legislation for clinical trial with an investigational medicinal product. For researchers working with medical devices, a specialized course focusing on ISO 14155 is recommended as well. The principles of Good Clinical Practice (GCP), quality management and requirements regarding the essential documents of the project, the application and reporting processes will be explained.

During the course examples will focus mainly on the present conditions for researchers in the Region of Southern Denmark and at the University of Southern Denmark.

For further information and application: GCP and investigator-initiated clinical trials