- email:registration@pti-europe.co.uk
- phone:+44 (0) 20 7017 7481
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Conducting Medical Device Trials in the EU
A 10 week self study course , self-study course
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COUNTRY SPECIFIC
...information - understand the different European marketsTHE BIG PICTURE
...post-trial considerations and purchaser preferencesIMPLEMENTATION
...subject recruitment, audit and risk managementCLASSIFYING A DEVICE
...assess product risk and choose the right market
Conducting Medical Device Trials in the EU
Clinical trials of medical devices are costly, time-consuming and can make or break the fortunes of a company, and two major changes have occurred recently that will affect their conduct. The first of these is a new Directive and the second is a new European Standard. These, in addition to the maze of other European and country specific regulations, need to be navigated with skill and knowledge in ordeer to ensure success.
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 and be guided through all the stages of a trial - from preparation to capitalising on the results.
10 week self study course for ALL regulatory professionals
Modules include:
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 The Regulatory Affairs Journal while the course lasts
Each module offers:
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