Strategic Management of Regulatory Affairs

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.