返回 Agenda
Session 2: Bioequivalence Considerations for Complex Generic Inhalation, Nasal, and Auto-Injector Drug-Device Combination Products (Continued)
Session Chair(s)
Kimberly A. Witzmann, MD
Acting Deputy Director, Office of Bioequivalence, Office of Generic Drugs, CDER
FDA, United States
Session 2: Bioequivalence Considerations for Complex Generic Inhalation, Nasal, and Auto-Injector Drug-Device Combination Products (Continued)
Speaker(s)
Moderator
Roisin Wallace
Viatris, Ireland
Vice President, Head of Global Device Development and Operations
Panelists
Denise Conti, PhD, MSc
FDA, United States
Senior Staff Fellow, Division of Therapeutic Performance, ORS, OGD, CDER
Panelists
Anthony Hickey
RTI International, United States
Distinguished Fellow
Panelists
Guenther Hochhaus, PhD
University of Florida, United States
Professor
Panelists
Jason D. Rodriguez, PhD
FDA, United States
Division Director, CDER/OPQ/OTR/Division of Complex Drug Analysis
Panelists
Kimberly A. Witzmann, MD
FDA, United States
Acting Deputy Director, Office of Bioequivalence, Office of Generic Drugs, CDER