Course Overview

Join NSF International at the Strengthening UK and US Medical Device and IVD Regulatory Collaboration seminar. We’re bringing together thought leaders from regulatory authorities and the device industry to discuss and plan for the effects of Brexit and the new EU MDR/IVDR. We’ll address strategies for strengthening regulatory relationships between the UK and the U.S., thus expanding options for European device and IVD manufacturers

Get Ready for a Regulatory Revolution: Learn About the Future of Regulation and the Challenges Ahead

If these questions concern you, don’t miss this unique opportunity:

  • How can industry plan and start regulatory strategies for implementation of the EU MDR/IVDR? 
  • Is the U.S. market a viable option for European manufacturers?
  • Can industry utilize the long-standing relationship between the UK Medicines & Healthcare products Regulatory Agency (MHRA) and the U.S. Food and Drug Administration (FDA)? 
  • What should manufacturers know about U.S. FDA’s innovative pathways to market and the transparent pre-submission process?
  • Are you ready for the approaching deadlines of the Medical Device Single Audit Program (MDSAP)?

When and Where

Choice of two events, register for one today!

Registration Fees

$300 USD per person (includes light breakfast, lunch and refreshments)

Agenda

  • Registration & Continental Breakfast
  • Welcome & Opening Remarks: James Pink and Kim Trautman, NSF International
  • Setting the Stage -- Brexit’s Impending Effects and EU New Regulations: James Pink
  • MHRA Perspective:  MHRA Speaker
    • Plan for EU Submissions and Minimizing Uncertainty 
    • Cooperation Between MHRA and FDA to Assist With Brexit Impacts
  • FDA Perspective: Ken Cavanaugh, CDRH, FDA
    • U.S./UK Mutual Recognition Agreement
    • U.S. FDA’s Strategic Priorities
  • Medical Device Single Audit Program: Kim Trautman, NSF International
    • Program Status & Challenges
  • Industry Perspective: Phil Brown, Director, Technical & Regulatory at ABHI 
    • EU MDR/IVDR Planning
    • Topics of Concern
  • U.S. FDA’s Paradigm Shift & Innovative Initiatives: Caroline Rhim, NSF International
    • Innovation Initiatives Equal Faster Times to Market
  • Break-Out Sessions & Group Discussions
  • Closing Remarks: James Pink and Kim Trautman, NSF International

Have a question or want to book a place? Contact Howard Broadbridge, you can also register online by clicking below.

Register