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2023 Combo Products Summit Agenda

session

Use Of Non-Integral Medical Devices In Medicinal Product Clinical Studies

November 29, 2023 @ 2:25 pm

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3:25 pm

Moderator

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

Speakers

Jonathan Amaya-Hodges, Director, Technical Services, Sutton Creek

Suzette Roan, Associate VP, Head of GRA Devices, Sanofi

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.

 

This conference IS co-sponsored by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services. The contents are those of the presenters and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. government.

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.

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