Download the Agenda – Evaluation & Certificate
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 |
View Recording Note: The first 8 minutes of Dr. Chazin’s presentation did not record properly. We will be re-recording his session and will have the new recording posted by May 1 |
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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