About the Conference

Regulatory tactics consist of managing the specific elements required for premarket submissions in the U.S. or elsewhere. A global regulatory strategy, on the other hand, is a much broader, more comprehensive assessment of the world’s regulatory and market potential landscape, and the development of a master plan aligned with a company’s ultimate business objectives.

A regulatory strategy involves both the evaluation and coordination of internal resources and an understanding of a dramatically changing global environment. Where are the preferred markets to achieve the company’s short- and long-term aims? What evidence or approvals from one region can be leveraged to facilitate access to another?

This unique, highly interactive workshop brings together senior regulatory leaders from the medical device industry with extensive experience in global regulatory strategy to share knowledge and best practices.

Who should attend:

  • Senior and mid-level regulatory professionals
  • Leadership track regulatory professionals
  • Senior business management
  • Business sector and product stewards
  • Board of directors members
  • Venture capitalists and investors

What you will learn:

  • Developing a regulatory strategy aligned with business strategy
  • Ensuring that a strategy is global, scalable, and flexible
  • Minimizing risks in the strategyv
  • Modifying strategy to adapt to a changing global regulatory and market environment
  • Incorporating internal and external factors in strategy
  • Driving effective execution of the strategy
  • Real-life case studies of both successful and failed strategies

Small and mid-sized company participants will also learn:

  • Understanding and fulfilling potential investor or acquirer expectations
  • Ensuring predictable milestones linked to key regulatory milestones
  • Minimizing the cost and complexity of securing regulatory approval in key markets

Large company participants will also learn:

  • Linking regulatory strategy to reimbursement and market access strategies
  • Leveraging data and experience from other development programs
  • Minimizing the time lag between market approvals around the world
  • Gaining or expanding access in global emerging markets

CEU Information

Attendees can earn CEUs. 1 hour of the conference = .1 CEU. MedTech Intelligence will provide you a Certificate of Attendance with the amount of CEU's earned about three weeks after the conference.

MTI's conference CEUs can be applied to your Regulatory Affairs Certification.

Details

  • Where

  • Hogan Lovells
    555 Thirteenth Street, NW
    Washington, DC 20004
    USA

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