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Session 0704: REGULATORY PERSPECTIVES ON DRUG-DEVICE COMBINATION PRODUCTS IN THE UNITED STATES AND IN CHINA
Session Chair(s)
Chi-Wan Chen, PhD
Pfizer, Inc., United States
Drug-device combination products is a rapidly growing field of medical products designed to enable targeted drug delivery, reduce physiological barriers to drug transport, provide dosing convenience, and/or enhance patient compliance. These products range from simple pre-filled syringes to more complex products like transdermal delivery systems and drug-eluting stents. This session will introduce how drugdevice combination products are regulated in the United States and discuss the technical and regulatory challenges in developing and approving these products for marketing. Product characterization, process controls, and quality assurance issues unique to pre-filled syringes, transdermal delivery systems, and drug-eluting stents will be presented.
Speaker(s)
Drug-Device Combination Products in US
Duu-Gong Wu, DrSc, PhD
PPD, United States
Senior Director, Global Regulatory Affairs
Drug-Device Combination Products in US
David LIN, PhD
Biologics Consulting Group, Inc., United States
Senior Consultant
Drug-Device Combination Products in China
Xinli SHI
CFDA Center for Medical Equipment & Skill Evaluation, China
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