This ½ day course provides you with an overview off all different aspects of liability and insurance legislation in Belgium and Europe with regards to clinical trials. You get to know the Belgian and European legislation for liability related to clinical trials and insuring clinical research, illustrated with concrete examples and practical implications.
This ½ day course aims to provide an overview on the different aspects of liability and insurance legislation in Belgium and Europe.
Topics include definition of terminology, the rules on liability and insurance in the Belgian and European legislation on clinical trials, as well as concrete examples, practical implications and suggestions for contracts
Course time13h00 - 17h00
Who should attend
Anyone working in clinical research who wishes to understand the liability and insurance requirements in clinical trials in Belgium and in the EU.
No legal background is needed to understand this course.
- Liability and Insurance - Definitions
- EU Regulation: liability and insurance in Clinical Trials
- Practical Implications, many concrete examples and suggestions for contracts
- Liability and Insurance Requirements in Belgium.
- Explain the meaning of different terms in Belgian and European liability and insurance legislation
- Get an overview of the liability and insurance aspects in the EU and Belgian legislation on clinical trials throughout practical examples
- Describe the practical liability and insurance implications for clinical trial contracts, as well as for insurance contracts
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (1)
- Ethical & Participants Safety Considerations (0)
- Investigational Product Development and Regulation (7)
- Clinical Studies Operations (GCPs or ISO 14155) (7)
- Study and Site Management (1)
- Data Management and Informatics (4)
- 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