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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 3: Quality Considerations for Generic Drug-Device Combination Products (Continued)

Session Chair(s)

Susan  Rosencrance, PhD

Susan Rosencrance, PhD

Acting Director, Office of Generic Drugs, CDER

FDA, United States

Session 3: Quality Considerations for Generic Drug-Device Combination Products (Continued)

Speaker(s)

Bing  Cai, PhD

Panelist

Bing Cai, PhD

FDA, United States

Division Director, OPQ, CDER

Intira  Coowanitwong

Panelist

Intira Coowanitwong

FDA, United States

Acting Quality Assessment Lead, OPQ, CDER

Gary  Henniger

Panelist

Gary Henniger

Teva Pharmaceuticals, United States

Sr Director, Global Device R&D Operations

Steven  Hertz, MBA, MS

Panelist

Steven Hertz, MBA, MS

FDA, United States

Consumer Safety Officer, Office of Pharmaceutical Quality, CDER

James Jefferis Norman, PhD

Panelist

James Jefferis Norman, PhD

FDA, United States

Senior Chemist, OPF, OPQ, CDER

Brock  Roughton

Panelist

Brock Roughton

FDA, United States

Acting Quality Assessment Lead, OPQ, CDER

Alan  Stevens, MS

Panelist

Alan Stevens, MS

FDA, United States

Acting Division Director, Division of Drug Delivery, General Hospital and Human

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