Running Medical Device Studies
About this course
Reasons to attend
You have clinical research experience in general, but somehow running clinical studies with medical devices still has some secrets for you? This course will provide you with a very practical set of information, tools and knowledge that will ultimately increase your competency level for running medical device studies. This course is also the core of our Medical Device STAR Programme.What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been granted PharmaTrain Recognition
Course schedule
We provide this course in two distinct formats: Classroom OR OnlineClassroom: 2-Day face-to-face: 09:00 - 17:00 | Online: 3 webinar sessions of 4 hours |
Course Description
This course focuses on the different phases of Medical Device Clinical Research, the different types of Medical Device studies, the regulatory framework and submission and approval pathways, a general overview of and the role of each team member (Sponsor, CRO (CRA, PM) and Site (Investigator, Study Coordinator) and other parties involved, as well as essential documents and data collection requirements. This course is specifically designed for people with a strong interest in Medical Devices, with or without a long track record.In addition to theory, interactive workshops will introduce the participants to the operations of Medical Device Clinical Research from each of their positions and roles. It will highlight how things are different compared to trials with medicinal products. The workshops will be organised as breakout groups to allow approaching the various topics from the different positions involved.Programme highlight
- The phases and types of Medical Device studies
- Study design challenges in Medical Device development
- The role of the team and parties involved in clinical studies with Medical Devices
- Differences between drug and device clinical studies from an operational point of view
Learning objectives
- Understand the set-up of Medical Device clinical studies and the challenges in study design
- Understand how to run clinical studies with medical devices from an operational perspective
- Recognise operational differences between trials with drugs and devices
Who should attend
Everyone starting to be involved in running clinical research with medical devices, both from the sponsors perspective as well as from the investigational site perspective.
At least 1-year experience in clinical studies is required.Competencies
This course covers competencies that are part of the ECCRT Competency Framework:
- Scientific Concepts & Research Design (1)
- Ethical & Participants Safety Considerations (1)
- Investigational Product Development and Regulation (4)
- Clinical Studies Operations (GCPs or ISO 14155) (9)
- Study and Site Management (7)
- Data Management and Informatics (2)
- Leadership and Professionalism (4)
- Communication (4)
- Teamwork (2)
- Business acumen (0)
Elisabeth Cobraiville
Cerhum
Tess Van Dam
BAAT Medical Products