SBIA Education Events

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

Generic Drugs Forum 2018 – Files Page

Download the Agenda

Day 1: April 11:

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
Brian Hasselbalch
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Good ANDA Submission and Assessment Practices and Software Support
Lisa Bercu, JD
Sarah Kurtz, PharmD
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Challenges in Generic Drug Safety and Surveillance
Howard D. Chazin, MD, MBA
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Note: Due to technical issues with the live recording, Dr. Chazin’s re-recorded his presentation after the event.
Electronic Submissions
Jonathan Resnick
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Using the ePortal to Submit a pre-ANDA Meeting
Kris André
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Q&A Panel Discussion
Sherwood, Hasselbalch, Bercu, Kurtz, Chazin, Resnick, André
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Pre-ANDA Meeting Process
Kris André
Katherine Tyner, PhD
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Orange Book – 101
Kun Shen, PharmD, MS, BCPS
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Determining Whether to Submit an ANDA or a 505(b)(2) Application
Elizabeth Giaquinto Friedman, JD, LLM
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Q&A Panel Discussion
Friedman, Shen, Tyner, Andre, and Kendra Stewart
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Day 2: April 12:

GDUFA II – Review Timelines
Vincent Sansone, PharmD, PMP
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Filing Review Basics – Examples of RTR
Bijal Patel, PharmD, BCPS
Mavis Mbi, PharmD, RPh.
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Best Practices for Conducting Bioequivalence Studies
Utpal Munshi, PhD
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Expectations for Including Facility and Site Information in Applications
Derek Smith
Jia Jian (JJ) Shen
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Microbiology Quality Assessment
Elizabeth Bearr, PhD
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Integrated Quality Assessment Process
Savan Khanna, PharmD
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Q&A Panel Discussion
Khanna, Bearr, Shen, Smith, Munshi, Patel, Mbi, Sansone,
and Julia Lee, PharmD and Andrea Bautista, JD, MBA
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GDUFA II User Fees: Update on Year One
Donal Parks MBA, MPM
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Generic Drug Product Quality Assessment
Robert T. Berendt, PhD
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Drug Substance Quality Assessment: Best Practices
Ramnarayan Randad, PhD
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Application Communications
Jennifer H. Nguyen, PharmD
Yen Anh Bui, Pharm.D.
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Laboratory Science to Support Risk-Based Quality Assessments
Jason D. Rodriguez, PhD
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Integrated Process and Facilities Assessment
Edwin Jao, Ph.D.
B.J. Ryan
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Q&A Panel Discussion
Ryan, Jao, Rodriguez, Anh Bui, Nguyen, Randad, Berendt, and Parks
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