Regulation of Combination Products and Other Technologies in the EU
Course date: 25 Nov 2014 - 27 Nov 2014
The course will ensure that delegates have a sound understanding of the regulations applying to a range of medical technology products including drug-device combinations, in vitro diagnostics and advanced therapy products (especially tissue engineered products). Delegates will learn to determine which regulatory framework applies and understand the principles of bringing products to market under the different frameworks. The module will focus upon European requirements and will emphasize the requirements for ‘borderline’ products, especially drug-device combinations.
Mitchell Hall, Cranfield campus. Bedfordshire. MK43 0AL
(includes refreshments at coffee breaks and buffet lunch)
Accommodation available if required. Please enquire for details.
How to register
To register an interest in this course please contact:
Academic Operations Unit
Bedford MK43 0AL
T: + 44 (0) 1234 754192
+ 44 (0) 1234 754193
F: + 44 (0) 1234 751206
10 Cranfield credits are available for this short course.
For an explanation of how credits can be accumulated through our short courses please click here.
The course content covers:
- The European regulatory framework for medicinal products including medicinal products with device features
- The process for, and issues with, CE Marking a medical device incorporating a medicinal product
- The content and format of submissions for medical devices incorporating medicinal substances to European medicines agencies
- Case study involving a medical device incorporating a medicinal product
- The European regulatory framework for advanced therapy products with a focus on tissue engineered products
- The European regulatory framework for IVDs
- The European regulatory framework for cosmetics
- Legal issues and precedents for the designation of borderline products.
Who should attend?
Regulatory affairs professionals.
Three days including lectures and practical sessions