MSc MTRA: Module 4 - Management of Regulatory Affairs and its Contribution to the Medical Product Lifecycle

Management of Regulatory Affairs and its Contribution to the Medical Product Lifecycle

Aim

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). This course is also Module 4 of the MSc in Medical Technology Regulatory Affairs and as such, would count towards the completion of the MSc if you were to successfully complete the assessments and enroll onto the qualification.

Lectures

Topics covered include:

• 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.

Learning outcomes

Upon completion of the course candidates will be able to:

• Advise on Global regulatory strategies and development programmes required to achieve medical device compliance/approval in Europe, North America and Japan
• List and discuss the skills and competencies required of the regulatory affairs professional in managing a department including, communication,
  training requirements and negotiation skills
• Manage a portfolio of products and describe the process of decision analysis and project planning
• Outline the marketing process and make a contribution to business strategy
• Display an understanding of systems for management of risk
• Demonstrate the confidence and skills required to interact with regulatory agencies and notified bodies.

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 parttime
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