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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

Panel Discussion

Speaker(s)

Markham  Luke, MD, PhD

Moderator

Markham Luke, MD, PhD

Director for Therapeutic Performance, Office of Generic Drugs, CDER, FDA, United States

Charles  DiLiberti, MS

Panelists

Charles DiLiberti, MS

President, Montclair Bioequivalence Services, LLC, United States

Xiaohui (Jeff)  Jiang

Panelists

Xiaohui (Jeff) Jiang

Division Deputy Director, Division of Therapeutic Performance, Office of Generic, FDA, United States

Darby  Kozak, PhD

Panelists

Darby Kozak, PhD

Lead for Complex Drug Substances and Dosage Forms, OGD, CDER, FDA, United States

Andrew A. LeBoeuf, JD, MS

Panelists

Andrew A. LeBoeuf, JD, MS

, Neurocrine, United States

Sam G. Raney, PhD, MS

Panelists

Sam G. Raney, PhD, MS

Associate Director for Science, ORS, Office of Generic Drugs, CDER, FDA, United States

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