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.
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.
Three days including lectures and practical sessions
This course has been developed in partnership with TOPRA, The Organisation for Professionals in Regulatory Affairs. The course is also Module 6 of Medical Technology Regulatory Affairs MSc.