Short course/CPD
Management of Regulatory Affairs & its Contribution to the Medical Technology Lifecycle
Course date: 12 Jun 2012 - 14 Jun 2012
Course overview
The course is designed to provide students with an understanding of the skills required to control regulatory affairs departments and to achieve worldwide compliance and approvals. This will include a clear appreciation of organisational, product and portfolio management and the politics of regulation (influencing and lobbying).
Location
Mitchell Hall, Cranfield campus. 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 book a place on the course please return the booking form to:
Lesley Roff
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
TOPRA (The Organisation for Professionals in Regulatory Affairs)
Course description
- Roles of the Medical Technology Regulatory Affairs Professional in managing the current regulatory systems and strategies for successful global registration;
- Strategic alliances, Mergers and Acquisitions and their impact on the regulatory process including the practice and principles of Due Diligence
- Product acquisition and divestment and the regulatory implications
- Business planning - product and portfolio management including the relationship between regulatory strategy and pricing and reimbursement considerations
- The politics of regulation – building effective problem solving, negotiation and lobbying skills
- The impact of electronic submissions and electronic document management and communication.
Who should attend?
Regulatory affairs professionals wishing to develop their understanding of the management of regulatory affairs.
Course format
2.5 days including lectures and practical sessions
The course is also Module 4 of Medical Technology Regulatory Affairs MSc.
