Content
The seminar teaches participants the basics of ISO 14155 and the Declaration of Helsinki. This answers the question of which points need to be particularly taken into account when planning and carrying out a study.
A particular focus in this unit is on the role and content of the study protocol (CIP) as the central document of a clinical study. All necessary content is discussed and its relevance to the various processes involved is explained. Practical tips and experiences are intended to complement the communication of the regulatory requirements.
Topic overview
- Basics of ISO 14155
- Declaration of Helsinki: Where does it come from and what significance does it have in the context of clinical trials?
- What points should you pay particular attention to when planning a study?
- Contents of the clinical investigation plan (CIP). For which other processes is the CIP required?
- Practical tips for implementation in practice
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
