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| Application Deadline: | The startdate is flexible, you can enrol through out the year. | ||
| Location: | Cranfield / United Kingdom / View location on map ▾ Hide location on map ▴ | ||
| Duration: | 24 months | ||
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| Languages: | English | ||
In today´s competitive and highly regulated healthcare environment, it is essential for companies to bring new products to the market quickly - and to keep them on the market. Excellence in managing regulatory issues is therefore a key strategic advantage to healthcare companies.
Regulatory affairs professionals play an important part in co-ordinating scientific endeavour with regulatory demands throughout the life of a product.
Cranfield´s qualification - in collaboration with The Organisation for Professionals in Regulatory Affairs (TOPRA) - combines TOPRA´s long-standing experience and expertise with Cranfield´s strong academic reputation and its links to industry. For the first time, it provides graduate professionals working in healthcare regulatory affairs with a recognised way of formalising your skills in the field, giving you an advanced theoretical understanding of the processes and practices central to medical device regulatory affairs.
Available on a part time basis only, this qualification is designed to be flexible in order to fit around your current job and responsibilities. For even greater flexibility, and for professionals with a specific interest, individual modules may be attended as standalone short courses, without the need to register for the full qualification.
The course is divided into three parts. Eight compulsory taught modules and, covering everything from the main principles of regulatory affairs to regulatory strategies used when taking new products to market. An Intergrating Portfolio and also a Personal Research Project and Thesis which gives you the chance to apply the skills, knowledge and understanding acquired during the taught phase of the course to a practical problem in regulatory affairs.
Modules:
Principles of European Medical Technology Regulatory Affairs
Design, Development and Testing Medical Technology
Clinical Evaluation of Medical Technology
Management of Regulatory Affairs and its Contribution to the Medical Product Lifecyle
Medical Device Vigilance, Post-market Surveillance (PMS) and Risk Management
Regulation of Drug-Device Combinations and Other Medical Technology Products
US Regulation of Medical Technology
Regulation Strategy in the Market Place
You are normally required to take an English Proficiency Test.
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A good honours degree in a science, business or management subject, preferably with experience in a relevant role within the healthcare industry. Where applicable, students must achieve a minimum IELTS score of 6.5 or TOEFL 580.
| Cambridge English: Advanced (CAE): | Grade C (Score: 60) |
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