Clinical Investigations: Implementation of MDR 2017/745 in Belgium
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|---|---|---|---|---|
| No sessions are planned at this time, however if you are interested in taking this course click here | ||||
| If you would like to have this course as an in-house session click here | ||||
About this course
Reasons to attend
The Medical Device Regulation MDR 2017/745 is into effect from May 2021 in Europe. In this course, you will learn how the MDR has been translated in Belgium and how clinical investigations with medical devices are carried out there.Learn more about the Implementation of MDR 2017/745 in Belgium!What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
Course schedule
We provide this course in two distinct formats: Classroom OR OnlineClassroom: 1/2-Day face-to-face: 09:00 - 12:30 | Online: 1 webinar session of 3 hours |
Course Description
In this half-day implementation of MDR training, we will zoom in on processes and legislative guidance documents implementing the MDR 2017/745 in Belgium. This course is complementary to our MDR Training.The course consists of 3 parts, covering translational aspects, submissions, and reporting of clinical investigations in Belgium: You will learn how submission for approval of clinical investigations works and finally, you will learn how reporting of your investigation (safety reports and study reports) works in Belgium.Programme highlight
- Belgian Translation of the MDR 2017/745
- Clinical investigation submissions in Belgium
- Reporting according to MDR 2017/745 & Fees
Learning objectives
- Understand how the MDR 2017/745 has been translated into practice in Belgium
- Learn how to submit your clinical investigation (or a substantial modification thereof) in Belgium
- Understand how to report safety events in Belgium
- Get an insight on how to report the end of an investigation in Belgium
- Know what to report at the end of an investigation in Belgium
Who should attend
Clinical Operations and regulatory staff from medical device companies or Investigators and study coordinators involved in running clinical trials with medical devices in Belgium.
Competencies
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (2)
- Investigational Product Development and Regulation (2)
- Clinical Studies Operations (GCPs or ISO 14155) (3)
- Study and Site Management (0)
- Data Management and Informatics (0)
- Leadership and Professionalism (0)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Trainers
Anonymous