Content
This unit explains specific tasks and obligations that must be observed as part of a clinical study. At the beginning, the roles and obligations towards national authorities and ethics committees are presented. This provides an insight into all regulatory notifications and approvals before and during a clinical study. The various actors involved in carrying out the study from the sponsor and the study centers and their tasks are then examined.
The seminar is rounded off with a list of the expectations of the notified bodies. This should also provide an insight into an adequate sample size calculation to ensure that the resulting clinical data can be meaningfully integrated into a clinical evaluation.
Topic overview
- Involvement of national and international authorities (competent authorities), e.g. B. BfArM, regional council
- Ethics vote
- Role definition: sponsor, patient, center, monitor
- Expectations of the notified bodies
- Requirements for biometrics: case number planning, statistics, databases, data management (overview)
target group
Employees from the areas of clinical and regulatory affairs, product management, business development, project managers, consultants, service providers for medical devices, authorities.
Prior knowledge
Knowledge of the EU MDR is recommended.
Funding opportunity
ESF funding is possible. Further information can be viewed here .
Early bird discount
If you register up to 3 weeks before the start of the seminar, you will receive an early bird discount of 10 percent.
KONTAKT:
Online
