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. Read more Read less
This will include a clear appreciation of organisational, product and portfolio management and the politics of regulation (influencing and lobbying).
At a glance
- Please enquire for course dates
- Duration3 days
- LocationCranfield Campus
Course structureThe course will be delivered in the form of a three-day residential workshop including lectures and practical sessions. Accompanying lecture notes, will be supplied and support the course throughout.
What you will learn
On completion of this three-day course delegates should be able to:
- Devise and defend a Global Regulatory strategy and development programmes required to achieve medical device compliance/approval in Europe, North America and Japan
- Critically evaluate the skills and competencies required by the regulatory affairs professional in managing a department including, communication, training requirements and negotiation skills
- Critically evaluate the role of regulatory affairs within a medical devices company
- Critically evaluate the factors required for effective interaction with regulatory agencies and Notified Bodies.
Topics covered by the course include:
- The impact of electronic submissions and electronic document management and communication
- 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
Who should attend
Regulatory affairs professionals wishing to develop their understanding of the management of regulatory affairs.
The course has been developed in partnership with TOPRA (The Organisation for Professionals in Regulatory Affairs).
Lectures will be delivered by a number of speakers from industry.
This course is non-residential. If you would like to book accommodation on campus, please contact Mitchell Hall or Cranfield Management Development Centre directly. Further information about our on campus accommodation can be found here. Alternatively you may wish to make your own arrangements at a nearby hotel.
Location and travel
Cranfield University is situated in Bedfordshire close to the border with Buckinghamshire. The University is located almost midway between the towns of Bedford and Milton Keynes and is conveniently situated between junctions 13 and 14 of the M1.
London Luton, Stansted and Heathrow airports are 30, 90 and 90 minutes respectively by car, offering superb connections to and from just about anywhere in the world.
Read our Professional development (CPD) booking conditions.