Content
During the seminar, participants are taught the goal and purpose of a clinical assessment. The applicable regulations are examined in more detail and the question of who the departments involved in the company are is answered. The link and connection to and with other documents in the technical documentation are shown.
The seminar also covers the topic of a clinical evaluation plan (CEP). Here it is clarified when a CEP has to be created, what the first steps are and what the structure of the CEP is.
Topic overview
Clinical evaluation
- Aim and purpose of the clinical evaluation
- At what point in the R&D process does the clinical evaluation occur?
- Applicable regulations and guidance documents
- Departments involved in the company
- Link/connection to other technical documentation (TD) documents
- Clinical evidence/level of evidence – what is it?
- Essential core data: indications/intended purpose/contraindications (precise definition/differences)
- Changes/adjustments under the EU MDR
Clinical Evaluation Plan (CEP)
- When will the CEP be created?
- The first step: The clinical development plan (CDP) as part of the CEP
- Structure and structure of the CEP
- Use of existing information (TD)
- What belongs in the CEP and what doesn't?
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
