The course is designed to provide regulatory affairs professionals with an insight into the strategic issues affecting the commercial and regulatory maintenance of a medical technology product throughout the product lifecycle, with focus on post-launch activities and future pressures.
The course addresses a number of issues facing regulatory professionals during the lifecycle of a medical technology product when considered from the following three perspectives; company internal requirements, external expectations and future demands.
- Medical Technology Products Lifecycle
- EU Legal procedures
- Good Regulatory practice issues for marketed products
- Issues in the market place
- Legal Issues I and II
- Theme crisis management
- Environmental pressures on Medical Technology Regulatory Affairs
- Public Policy – Influencing the regulatory environment
- The value of trade associations
- Advertising and promotional issues/ Date privacy and protection
- Logistics and supply chain issues
- Future issues/ reimbursement
Lectures will be delivered by a number of speakers from industry.
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 8 of Medical Technology Regulatory Affairs MSc.