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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

Moderator

Roisin Wallace

Viatris, Ireland

Vice President, Head of Global Device Development and Operations

Denise  Conti, PhD, MSc

Panelists

Denise Conti, PhD, MSc

FDA, United States

Senior Staff Fellow, Division of Therapeutic Performance, ORS, OGD, CDER

Anthony  Hickey

Panelists

Anthony Hickey

RTI International, United States

Distinguished Fellow

Guenther  Hochhaus, PhD

Panelists

Guenther Hochhaus, PhD

University of Florida, United States

Professor

Jason D. Rodriguez, PhD

Panelists

Jason D. Rodriguez, PhD

FDA, United States

Division Director, CDER/OPQ/OTR/Division of Complex Drug Analysis

Kimberly A. Witzmann, MD

Panelists

Kimberly A. Witzmann, MD

FDA, United States

Acting Deputy Director, Office of Bioequivalence, Office of Generic Drugs, CDER

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