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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: 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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