Content
During the seminar, participants are taught the goal and purpose of a clinical trial as well as the overarching connections in the overall process with the clinical assessment. The focus of this unit is to provide a structured overview of the applicable regulations and standards in the context of a clinical trial, as well as the parties/actors involved. The different types of clinical trials in relation to the product life cycle are also explained.
The seminar is rounded off by explaining the connections between clinical assessment and clinical trials as well as answering the question of how the selected objectives and questions can be planned in a sensibly coordinated manner.
Topic overview
Clinical trial
- Aim and purpose of the clinical trial
- Applicable regulations and guidance documents
- When are clinical trials mandatory and when not?
- Which parties are involved in a clinical trial (internal/external)?
- What types of clinical trials are there and which ones suit which questions?
Relationship between clinical assessment and clinical testing
- How can clinical questions be derived from possible open points in a clinical evaluation?
- What defines the design and objective of a clinical trial?
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
