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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

Bing Cai, PhD

Division Director, OPQ, CDER , FDA, United States

Panelist

Intira  Coowanitwong

Intira Coowanitwong

Acting Quality Assessment Lead, OPQ, CDER, FDA, United States

Panelist

Gary  Henniger

Gary Henniger

Sr Director, Global Device R&D Operations , Teva Pharmaceuticals, United States

Panelist

Steven  Hertz, MBA, MS

Steven Hertz, MBA, MS

Consumer Safety Officer, Office of Pharmaceutical Quality, CDER , FDA, United States

Panelist

James Jefferis Norman, PhD

James Jefferis Norman, PhD

Senior Chemist, OPF, OPQ, CDER, FDA, United States

Panelist

Brock  Roughton

Brock Roughton

Acting Quality Assessment Lead, OPQ, CDER, FDA, United States

Panelist

Alan  Stevens, MS

Alan Stevens, MS

Global Head, Complex Devices and Drug Delivery Systems, AbbVie, United States

Panelist

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