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Plenary

Breaking Barriers: The Power of Regulatory Reliance

Thursday, April 24, 2025
8:15 AM - 9:30 AM East Coast USA Time
Location: Regency Ballroom – 3rd Floor
In a rapidly evolving global regulatory landscape, reliance has emerged as a key driver for fostering innovation and ensuring timely patient access to medical devices, including IVDs. This session delves deep into how regulatory reliance is being implemented globally, highlighting key successes and ongoing challenges and sharing ways to operationalize reliance pre- and post- market. Join us as representatives from regulators and industry share their unique perspectives, from regulators' efforts and their commitment, to the industry's role in advancing reliance practices. Attendees will gain valuable insights into the future of reliance and its importance to streamlining regulatory approvals, reducing duplication of effort, and accelerating market access.

    Moderator(s)

  • Fatemeh Razjouyan

    Director of Regulatory Policy, International and Harmonization | Global Regulatory Policy
    Medtronic

    View Slides

    • Speaker(s)

  • Karen Noffs

    Head of Pre-Market Approval of Medical Device
    Anvisa - Brazil

  • Tammy Steuerwald

    Global Head of Regulatory Policy, Foundational Principles and Supranational Organizations
    Roche