Plenary

Breaking Barriers: The Power of Regulatory Reliance

Thursday, April 24, 2025

8:15 AM – 9:30 AM East Coast USA Time

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 FDA, Brazil’s ANVISA, and industry share their unique perspectives, from regulators' efforts and FDA’s 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

Speaker(s)

MT

Melissa Torres

Associate Director for International Affairs, Center for Devices and Radiological Health (CDRH)
FDA (Invited)
Karen Noffs

General Manager, Office of Medical Devices
Anvisa
Tammy Steuerwald

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