Preconference Workshop

Applied

Developing Your Global Medical Device Regulatory Strategy

Workshop Leader(s)

• 

  Nicole Landreville, P.Eng, RAC, FRAPS

  Regulatory Affairs Manager
  GE Healthcare Madison WI USA (Madison, WI)

Speaker(s)

• 

  Megha Iyer, MS, RAC

  Global Director, Regulatory Affairs
  Thermo Fisher Scientific
• 

  Bradley Hossack, Bsc

  Vice President Global Regulatory Affairs
  Stryker - ENTERPRISE
• 

  Patrick Lee, PE, MS, MBA, RAC

  Director of Regulatory Affairs
  BioCardia Inc.

Putting together a global regulatory strategy can be very challenging for Regulatory Affairs Professionals. Knowing how to develop an effective global regulatory strategy is an essential skill for regulatory professionals. This two-day strategic workshop provides a rich panel of experts that are committed to making sure students learn the process of developing a solid global regulatory strategy for medical device.

Agenda

Learning Objectives:

• Compile a solid and effective Regulatory Strategy Plan for a medical device being placed on the global market.
• Apply the methods learned during the workshop in day to day regulatory affairs projects.
• Describe key challenges faced by regulatory professionals in navigating the global regulatory landscape when trying to bring a medical device to product to market.