SBIA Education Events

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

Generic Drugs Forum 2017 – Files Page

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April 4:

Keynote
Kathleen Uhl, MD
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Pharmaceutical Quality Update
Michael Kopcha, PhD, RPh
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ANDA Performance/Operations Update
Edward “Ted” Sherwood
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OPQ Policy Update
Ramesh Menon, JD
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GDUFA Regulatory Science Research Update
Stephanie H. Choi, Ph.D.
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Preparing for GDUFA II User Fees
Donal Parks MBA, MPM
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eCTD
Jonathan Resnick
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Q&A Panel Discussion
Parks and Resnick
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GDUFA II
Amy Bertha
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Development of Single, Shared System REMS
Elaine Lippmann, JD
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Introduction to “The ANDA Pathway”
Tom Hinchliffe
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ANDA Policy and Regulatory Considerations Prior to Filing
Martha Nguyen, JD
Maarika Kimbrell, JD, MS
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Q&A Panel Discussion
Bertha, Lippmann, Hinchliffe, Nguyen and Kimbrell
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April 5:

Filing Review – Do’s and Don’ts
Rosanne Chandra, PharmD
Ankit Ghodasara, PharmD
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RPM Communications Associated with “Take Action” Process (Complete Responses and Approval)
Dawn Kimble-Vance, RPh, PN
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FDA’s Bioequivalence Recommendations for Generic Drug Products
Xiaojian Jiang, PhD
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Review of Clinical Endpoint Bioequivalence Studies in ANDAs
Carol Kim, PharmD
Michael Spagnola, MD
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Generic Drug Labeling: Strategies for Providing High-quality Submissions
Lillie Golson, PharmD
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Q&A Panel Discussion
Lee, Chandra, Ghodasara, Kimble-Vance, Jiang, Kim, Spagnola, Golson
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OPQ Integrated Quality Assessment (IQA) Process
Don Henry
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OPQ Communications with Industry
Robert Gaines, PharmD, MBA
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Drug Substance
Benjamin Lim, PhD
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Generic Drug Product Quality Review
Guoping Sun, PhD
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Dissolution Method Development for Generic Drug Products – Present and Future Considerations
Banu Sizanli Zolnik, PhD
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Manufacturing Process and Controls: How to Avoid Major Review Issues Turning into Potential Deficiencies/Approvability Issue
Nallaperumal Chidambaram (Chid), PhD
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Facility Evaluation and Inspection
B.J. Ryan
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Product Quality Microbiology Assessment: The What and The Where
Marla Stevens-Riley, PhD
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Q&A Panel Discussion
Henry, Gaines, Lim, Sun, Zolnik, Chidambaram, Ryan, & Stevens-Riley
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