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Bethesda North Marriott Hotel and Conference Center

25 oct 2017 7:00 a.m. - 26 oct 2017 3:30 p.m.

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Combination Products Conference

Innovation and New Frontiers

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Session 5: Generics for Combination Products: It’s Complicated

Session Chair(s)

Kim Quaintance-Lunn

Kim Quaintance-Lunn

Vice President, Head of Regulatory Science and Execution

Alexion, United States

FDA Commissioner Gottlieb has made the approval of generics including complex generics, especially drug-device combinations, a top priority for the agency. This session will focus on the challenges associated with generics for combination products, ongoing regulatory science initiatives at CDER, and legislative changes designed to accelerate the availability of these products.

Learning Objective :
Discuss challenges associated with establishing bioequivalence for generic products
Describe ways to establish bioequivalence for combination products
Summarize legislative changes affecting generics for combination products

Speaker(s)

Robert A. Lionberger, PhD

Speaker

Robert A. Lionberger, PhD

FDA, United States

Director, Office of Research and Standards, Office of Generic Drugs, CDER

Devices for Drug-Device Combo Products – How Similar is Similar?

Cory Wohlbach

Teva Pharmaceuticals, United States

Global Vice President, Biosimilar Regulatory Affairs

Speaker

Kurt R. Karst, JD

Hyman, Phelps & McNamara, PC, United States

Director, Prescription Drugs and Biologics, Corporate Transactions, Enforcement

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