MSc MTRA: Module 6 - Regulation of Drug-Device Combinations and other Medical Technology Products

Regulation of Drug-Device Combinations and Other Medical Technology Products

Aim

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 course will focus upon European requirements and will emphasize the requirements for ‘borderline’ products, especially drug-device combinations. This course is also module 6 of the MSc in Medical Technology Regulatory Affairs. Completion of the course and its associated assessments counts towards the MSc qualification.

Lectures

Topics covered include:

• 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.

Learning outcomes

Upon completion of the course candidates will be able to:

• Critically evaluate factors that might be used to select a regulatory framework for a particular product (e.g. as a cosmetic, a device or a medicine)
• Critically analyse and apply the development of strategies for CE Marking medical devices incorporating medicinal products
• Critically evaluate the principles that influence and determine the regulatory designation of borderline products
• Describe the European regulatory framework for some important types of medical products
• Advise on submission requirements for CE marking.

Teaching and learning methods

Lecturers are drawn from a variety of backgrounds and all are recognised experts currently working in the field of Medical Device Technology related
regulatory affairs. There will be a mix of formal lectures, tutorials, discussions and case studies.

Medical Technology Regulatory Affairs MSc

In collaboration with TOPRA, the Cranfield MSc provides for the first time a recognised way for professionals working within healthcare regulatory affairs or related areas to formalise their skills in the field of medical technology. Available on a part-time basis only, the MSc is designed to be flexible to fit around your current job and responsibilities. The course is also available at Diploma and Certificate levels. For even greater flexibility, and for professionals with a specific interest, individual modules can be attended as standalone three-day short courses.

For more information about our MSc please contact our Enquiries Office Tel: +44 (0) 1234 758008 Email: enquiries.health@cranfield.ac.uk

In order to access comprehensive information about this particular MSc, please click on the following link - Enquiry Form