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2019 Complex Generic Drug Product Development Workshop
September 25-26

Full Agenda

Agenda & Speaker Bios

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Event Agenda

The agenda is subject to change. Updated versions will be linked here as they become available. The current version is 6, uploaded on September 24, 2019.

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Speaker Biographies

This PDF file contains brief biographies of the FDA speakers participating in the conference.

Files, Certificate & Recordings

Session Recordings:

The links to the recordings (below) will become active within 24 hours after each session concludes.

Day One:

  • Opening Remarks/Keynote: Sally Choe
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  • Pre-ANDA Program Update – Karen Bengtson & Suneela Prodduturi
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  • FDA’s Inactive Ingredient Database: Improvements on the Path to 2020 – Susan Zuk
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  • Q&A and Panel Discussion
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  • Research Activities, Scientific Advances, & Modernization of Bioequivalence Standards for Generic Topical and Transdermal Products – Sam Raney
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  • Innovation and Harmonization of Bioequivalence Standards for Generic Topical and Transdermal Products – Priyanka Ghosh
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  • Best Practices & Efficient Strategies for Generic Topical Product Development – Tannaz Ramezanli
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  • Critical Quality Considerations for Transdermal Delivery Systems – Brock Roughton
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  • Q&A and Panel Discussion
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  • Characterization and Comparative Evaluation Strategies to Demonstrate Complex API Sameness – Deyi Zhang
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  • Complex Peptide ANDAs: Test and Reference Product Comparability Studies from a Quality Perspective – Cameron Smith
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  • Development, Characterization, and Evaluation Considerations of Particle Analysis to Support Generic Product Quality and Bioequivalence Determination – Xiaoming Xu
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  • Q&A and Panel Discussion
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  • Bioequivalence Approaches for Long Acting Drug Products: Regulatory and Scientific Considerations – Yan Wang
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  • Characterization and Comparative Evaluation Strategies to Demonstrate Complex Excipient Sameness – Bin Qin
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  • Considerations on In Vitro Drug Release Testing for Long Acting Drug Products for Quality Control Purpose – Vidula Kolhatkar
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  • Q&A and Panel Discussion
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Day Two:

  • Overview of Drug-Device Combination and What Constitutes Complex Drug-Device Combination – Lisa Bercu
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  • Overview of Comparative Analyses (Clinical Perspective) – Michelle Lin
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  • Injectable Product Considerations From a Quality Perspective – Bita Mirzai Azarm
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  • Comparative Analyses: Focus on Injectable Drug-Device Combination Products – Andrew Fine
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  • Q&A and Panel Discussion
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  • PSG Recommendations and Updates for OINDPs – Bryan Newman
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  • Considerations for Pre-ANDA Meeting Requests for Orally Inhaled and Nasal Drug Products – Denise Conti
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  • Comparative Analysis: Device and User Interface Considerations – Kimberly Witzmann
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  • Bioequivalence Considerations for Conducting Bridging Studies with OINDPs – Tian Ma
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  • CMC Updates and Other Considerations for Generic Orally Inhaled Drug Products – Fang Yuan
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  • Q&A and Panel Discussion
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  • General Overview: The Use of Quantitative Methods and Modeling to Facilitate Generic Drug Development and Regulatory Assessment – Liang Zhao
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  • PK/PD Meta-analysis of Abuse Deterrent Opioid Drug Products: PSG Development, Research and ANDA Assessment – Lucy Fang
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  • Regulatory Considerations on Dose-scale Analysis in Assessing Pharmacodynamic Equivalence – Xiajing Gong
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  • Physiologically-based Pharmacokinetic Modeling and Simulation Approaches: Best Practices for Regulatory Applications Related to Locally-acting Generic Drugs – Eleftheria Tsakalozou
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  • Credibility Establishment for Computational Fluid Dynamics Models of Complex Generic Drug Delivery – Ross Walenga
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  • Application of Quantitative Clinical Pharmacology (QCP) in Development of Long Acting Injectable Products – Satish Sharan
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  • Q&A and Panel Discussion & Closing Remarks
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