Short course/CPD
Regulation of Combination Products and Other Technologies in the EU
Course date: 25 Nov 2014 - 27 Nov 2014
Course overview
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.
Location
Mitchell Hall, Cranfield campus. Bedfordshire. MK43 0AL
Course fee:
£1,300.00
(includes refreshments at coffee breaks and buffet lunch)
Accommodation fee:
Accommodation available if required. Please enquire for details.
How to register
To register an interest in this course please contact:
Lesley Jellis
Academic Operations Unit
Cranfield University
Bedford MK43 0AL
T: + 44 (0) 1234 754192
+ 44 (0) 1234 754193
F: + 44 (0) 1234 751206
E: shortcourse@cranfield.ac.uk
Accreditation
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.
Course description
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.
Course format
Three days including lectures and practical sessions
The course is also Module 6 of Medical Technology Regulatory Affairs MSc. This course has been developed in partnership with TOPRA (The Organisation for Professionals in Regulatory Affairs).
