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2023 Combo Products Summit Agenda

session

Navigating Combination Product Pathways: Industry Experiences And FDA’s Role

November 30, 2023 @ 8:15 am

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9:15 am

Moderators

Chin-Wei Soo, Global Regulatory Head – CMC/Devices and Combination Products, Genentech

Rumi Young, Director, Regulatory Policy, BD

Speakers

Chelsea O’Connell, Director, Global & Regulatory and R&D Policy at Amgen

Kristina Lauritsen, Combination Product Policy Advisor, Center for Drug Evaluation and Research (CDER) FDA

Sarah Mollo, Combination Products Analyst, Center for Devices and Radiological Health (CDRH), FDA

Winifred Wu, President and Principal Advisor, Strategic Regulatory Partners, LLC

Depending on the primary mode of action (drug, device or biologic) a combination product is assigned to an FDA center (CDER, CBER and CDRH) for premarket review and regulation. FDA’s Office of Combination Product provides guidance to industry in the process but there are also Center liaisons known as product jurisdiction officers that play a role in combination product designation and policy.   For these products, industry experts will share real-world experiences and best practices associated with FDA engagement pathway(s) throughout the product life cycle. The roles of FDA jurisdiction officers play in the inter-center consult request (ICCR), policies and regulatory decision making will be explored.

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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