Conducting Medical Device Trials in the EU
The EU now includes 25 countries and almost half a billion citizens so there has never been a better time to maximise your product development processes against the competition. This course will help you understand the European clinical trial process for medical devices.
Clinical trials of medical devices are costly, time-consuming and can make or break the fortunes of a company. What's more, European law is a maze of regulations that needs to be navigated with skill and knowledge.
Over 10 weeks, the course provides a comprehensive understanding of EU clinical trials. It explains recently updated regulations, shows you how to choose the best approval route and solves the problem of trial management. You will learn why, when and how to conduct a clinical trial with this guide that takes you through all the stages - from preparation to capitalising on the results.
10 week self study course for ALL regulatory professionals
Modules include:
- Module 1 – Regulations read more
- Module 2 – Reimbursement read more
- Module 3 - Classifying a device read more
- Module 4 - Choosing the device approval route read more
- Module 5 - Planning read more
- Module 6 – Preparatory read more
- Module 7 – Implementation read more
- Module 8 – Closing read more
- Module 9 - Country-specific information read more
- Module 10 - The big picture read more
Each module offers:
Benefit from:
- Hard copy modules sent to you week-by-week
- Expert advice from our on-hand tutor who is available for questions
- Start dates that fit into your personal calendar
- In-depth practical guidance, allowing you to put everything you learn into action immediately
- User-friendly, self-study materials to use as a valuable reference tool after the course finishes
- FREE online access to leading newsletters - Clinical World Technology News and EURAlex while the course lasts
Who is this course aimed at?
For clinical trial specialists
This course will give you a solid understanding of how clinical trials work in the EU. Learn how the law is evolving and check your procedures against the most up-to-date regulatory requirements. By the end of the course, you will have a clear map through the trial process and the know-how to get your product to market faster.
For medical device professionals
Conducting Medial Device Trials in the EU gives you detailed insight into the key aspects of the clinical trial process. The course looks at individual countries, as well as European regulations, and shows you how successful clinical trials fit into your business.
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Connect with the PTI faculty! PTI is a global pharmaceutical training company with over 60 interctive courses focusing on Regulatory Affairs, R&D, Clinical, Business Strategy, Fine Chemicals, Biopharmaceuticals, Manufacturing, Medical Devices and Agrochemicals
