Aligning Risk Management Approaches Between Sponsors, Suppliers, and CDMOs

2024 Combo Products Summit Workshop

session

Aligning Risk Management Approaches Between Sponsors, Suppliers, and CDMOs

October 8, 2024 @ 1:00 pm

3:00 pm

Moderators

James Wabby, Head – Global Regulatory Affairs, Emerging Technologies, Combination Products, and Devices, AbbVie Inc.

Facilitators

Carolyn Dorgan, Director, Technical Services, Suttons Creek, Inc.

James Wise, Combination Products Drug Delivery Devices, CSL Behring

Carsten Schaufuss, Director, Combination Products, CSL Behring

Panelists

Khaudeja Bano,Vice President Combination Product Quality, Ex Amgen

Jerzy Wojcik, VP Regulatory and Quality Services, Edgeone Medical (CDMO)

Laxman Halleppanavar, Head of Portfolio Strategy and Management, Credence Med

Courtney Evans, Principal Regulatory Consultant, Suttons Creek, 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.

Special thanks for Susan Neadle for contributing to the development of this workshop topic.

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.

2024 Combo Products Summit Workshop

session