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April 22:
| Keynote: Update on Generic Drugs Edward “Ted” Sherwood |
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| Overview of Office of Pharmaceutical Quality (OPQ) Larisa C. Wu, Ph.D |
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| GDUFA Implementation Update Keith Flanagan, J.D. |
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| Hatch-Waxman Patent and Certification Process 101 Maryll W. Toufanian, J.D. Martin Shimer, R.Ph. |
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| ANDA Pre-Approval Inspections, case histories and current Topics Krishna Ghosh, Ph.D. |
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| Current Regulatory Practice in Type II API DMF Review Huyi Zhang, Ph.D. |
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| Proper Regulatory Submission During the Lifecycle of Generic Drug Products: Drug Product Perspective Geoffrey Wu, Ph.D. |
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| The Drug Supply Chain Security Act: Readiness and Implementation Connie T. Jung, R.Ph., Ph.D. |
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April 23:
| Stability Recommendations Considered for Filing Acceptance Johnny Young, M.A. |
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| GDUFA Regulatory Science Robert A. Lionberger, Ph.D. |
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| Update on Question-based Review Robert Iser, M.S. |
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| ANDA Stability Guidances Radhika Rajagopalan, Ph.D. Suhas Patankar, Ph.D. |
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| Real Time Communications and the Office of Lifecycle Drug Products Glen Smith, M.S., M.A.S. |
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| User Fee Insights – How Other People Are Getting Their User Fee Obligations Wrong Gisa Perez, M.B.A. |
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| Dissolution Method Development for Generic Drug Products Banu Sizanli Zolnik, Ph.D. |
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| Amendments to Original ANDAs and PASs under GDUFA Elizabeth Giaquinto, J.D., L.L.M. |
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