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.
Course time08h30 - 12h45
Who should attend
Clinical Operations staff who need to know the basics on how IMP is manufactured and managed in the context of a clinical trial.
- Introduction to GMP
- Import, Packaging and Distribution of IMPs
- Clinical Release (Workshop)
- Testing and Release of IMP
- Get an understanding on the basic principles of Good Manufacturing Practices
- Get an understanding of the role of the Qualified Person in the manufacture of clinical trial materials
- Get an understanding on how the packaged clinical trial material gets to the clinic before trial commencement
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (0)
- Investigational Product Development and Regulation (3)
- Clinical Studies Operations (GCPs or ISO 14155) (0)
- Study and Site Management (0)
- Data Management and Informatics (0)
- Leadership and Professionalism (0)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained