戻る Agenda
Session 5: Generics for Combination Products: It’s Complicated
Session Chair(s)
Kim Quaintance-Lunn
Vice President, Head of Regulatory Science and Execution
Alexion, United States
Learning Objective :
Speaker(s)
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