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Sheraton Silver Spring

Oct 09, 2018 7:30 AM - Oct 10, 2018 5:15 PM

8777 Georgia Ave, Silver Spring, MD 20910

Complex Drug-Device Generic Combination Products Meeting

Session 2: Bioequivalence Considerations for Complex Generic Inhalation, Nasal, and Auto-Injector Drug-Device Combination Products (Continued)

Session Chair(s)

Kimberly A. Witzmann, MD

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)

Roisin  Wallace

Roisin Wallace

Vice President, Head of Global Device Development and Operations, Viatris, Ireland

Moderator

Denise  Conti, PhD, MSc

Denise Conti, PhD, MSc

Senior Staff Fellow, Division of Therapeutic Performance, ORS, OGD, CDER, FDA, United States

Panelists

Anthony  Hickey

Anthony Hickey

Distinguished Fellow, RTI International, United States

Panelists

Guenther  Hochhaus, PhD

Guenther Hochhaus, PhD

Professor, University of Florida, United States

Panelists

Jason D. Rodriguez, PhD

Jason D. Rodriguez, PhD

Division Director, CDER/OPQ/OTR/Division of Complex Drug Analysis, FDA, United States

Panelists

Kimberly A. Witzmann, MD

Kimberly A. Witzmann, MD

Acting Deputy Director, Office of Bioequivalence, Office of Generic Drugs, CDER, FDA, United States

Panelists

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