You have clinical research experience, but the field of medical devices is new to you? Then this introductory course is something for you. It will give you the overview, allowing you to understand the basic concepts and differences with the pharma R&D. It is a good way to get familiar with definitions and terms typically used in this industry. It also serves as a wonderful opening of our Medical Device STAR Programme.
This one-day course is designed to introduce the fundamental concepts of clinical trials with medical devices.
We will work through definitions and classification of different types of medical devices and touch on the main differences with pharmaceutical products.
You will learn about the high level medical device regulatory context in both EU and US.
Course time09h00 - 17h00
Who should attend
Everyone involved in clinical research who recently entered or will enter to the medical device field.
- Definitions and classification of medical devices
- Overview of European and US medical device regulatory requirements
- Differences between drug and device clinical trials
- Differentiate between various types of medical devices
- Learn the basics of European and US medical device legislation
- Identify documentation requirements specific to medical devices
- Recognize differences between drug and device development
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (3)
- Ethical & Participants Safety Considerations (1)
- Investigational Product Development and Regulation (4)
- Clinical Studies Operations (GCPs or ISO 14155) (1)
- Study and Site Management (0)
- Data Management and Informatics (0)
- Leadership and Professionalism (0)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained