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Use of Non-integral Medical Devices in Medicinal Product Clinical Studies

11-29-2023 @ 2:25 pm 3:25 pm

Join us as we examine the challenging regulatory requirements for pursuing use of non-integral Medical Devices in global medicinal product clinical studies, including submission considerations and the different regulatory pathways. A Combination Products Coalition proposal for regulatory considerations that uses a risk-based framework will be presented. Then interact with an industry case study for an on-body delivery system that explores the global regulations and guidance driving the different regulatory submission strategies, while providing practical learnings based on the challenges encountered.


  • Jason Lipman, Senior Director, Global Regulatory Affairs, Device and Combination Products, Sanofi


  • Jonathan Amaya-Hodges, Director, Technical Services, Sutton Creek
  • Suzette Roan, Associate VP, Head of GRA Devices, Sanofi
1300 Houston Street
Fort Worth, Texas 76102 United States