This ½-day course is especially designed for clinical operation teams, to get an understanding of the Good Manufacturing Principles (GMP) in relation to management of Investigational Medicinal Product (IMP) in the framework of a clinical trial.
During the brief introduction on the manufacturing of clinical trial material, the participants will get an overview at a glance on the processes before the material is received in the clinic. The half day course will discuss the European GMP on a high level, the importation and packaging of IMP’s and the two-step approach as applied for the release of the material for clinical trials. Next to that a brief introduction will be given on the release and shelf life testing of IMP’s and how this influences the labelling strategy for the IMP.
This course is designed as an optional add-on to our Clinical Project Management course but can also be followed independently.