The Medical Device world is fundamentally different from the Pharmaceutical environment: different products and legislations, different concepts, different strategies: all requiring a specific approach during the entire development phase of the product.
Are you a starter in Clinical Research with Medical Devices?
Are you an experienced CRA or a Junior Project Manager with limited experience in Medical Device Clinical Operations?
Or are you an investigator or study coordinator who wishes to get a better view on Device development?
In 5-day STAR program, you will find a broad variety of expertise levels from both sponsor and investigator side. This mixture will guarantee a dynamic learning environment for all participants.
Course time09h00 - 17h00
The courses included in the Medical Device STAR programme are selected to provide the essential competencies needed for you to work in the field of Medical Device Research. The programme is composed of the following courses:
- Introduction to Clinical Research with Medical Devices (1-day)
- Running Medical Device Trials (2-day)
- ISO 14155 Training (1-day)
- Medical Device Regulations (1-day)
These courses are organised twice a year, you can either follow them consecutively (in 1 week) or compose your own schedule over the 2 occasions.
This series of courses cover 86% of competencies that are needed to carry out Medical Device Clinical Investigation as described in the ECCRT Competency Framework
- Scientific Concepts & Research Design (2)
- Ethical & Participants Safety Considerations (5)
- Investigational Product Development and Regulation (6)
- Clinical Studies Operations (GCPs or ISO 14155) (9)
- Study and Site Management (6)
- Data Management and Informatics (2)
- Leadership and Professionalism (4)
- Communication (2)
- Teamwork (1)
- 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.