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2024 Combo Products Summit Workshop

session

Aligning Risk Management Approaches Between Sponsors, Suppliers, and CDMOs

October 8, 2024 @ 1:00 pm

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3:00 pm

Speakers

Carolyn Dorgan, Director, Technical Services, Suttons Creek
Laxman Halleppanavar, Head of Project Management, Credence Med
Jerzy Wojcik, VP Regulatory and Quality Services, Edgeone Medical (CDMO)

Facilitators

Susan Neadle, Principal Consultant & President, Combination Products Consulting, LLC
James Wabby, Head – Global Regulatory Affairs, Emerging Technologies, Combination Products, and Devices, AbbVie Inc.

Sponsors, suppliers, and CDMOs may not all use consistent risk management approaches. This is a significant challenge in the combination product space, where most sponsors are dependent upon a third party for at least one critical aspect of the development and/or lifecycle management process. This session will discuss some of the challenges and opportunities and provide a framework for success.

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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