SBIA Education Events

US FDA – Center for Drug Evaluation & Research – Small Business & Industry Assistance

Generic Drugs Forum 2015 Files

The resource links below are available only to registered participants.

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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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