Short course/CPD
Clinical Evaluation of Medical Technology
Course date: 24 Feb 2014 - 26 Feb 2014
Course overview
The course is designed to help regulatory professionals understand the fundamentals of the clinical trial process, such that they then have a suitable working framework from which to develop specific interrogation of problems and the development of solutions, when dealing with clinical trial issues in relation to product development and registration strategy.
Location
Cranfield University, Cranfield, 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 aims to provide an understanding of when a clinical investigation is necessary, the regulatory processes involved and the alternative routes to demonstrate compliance to performance under essential requirements, as well as the safety and efficacy of the intended purpose of the technology. Thereby enabling delegates to provide strategic regulatory advice on the clinical development programme.
Course content
- Types and designs of clinical studies
- Preclinical requirements
- Clinical evaluation and when to do a study
- Good clinical practice (ISO 14155)
- Clinical trial supplies and labelling
- Post market surveillance studies
- Health economics and device trials
Who should attend?
Regulatory affairs professionals wishing to develop their understanding of the fundamentals of the clinical trial process.
Course format
Three days including lectures and practical sessions
The course is also Module 3 of Medical Technology Regulatory Affairs MSc. The course has been developed in partnership with TOPRA (The Organisation for Professionals in Regulatory Affairs).
