SBIA Education Events

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

Complex Generic Drug Products Conference 2018 – Files Page

Download the Agenda  – Speaker Bios

Final Evaluation & Certificate

Day 1: September 12:

Opening Remarks
Kathleen Uhl, MD
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SESSION 1: Overview of Pre-ANDA Program for Complex Generic Drug Products
Pre-ANDA program overview
Lei Zhang, PhD (OGD/ORS)
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Pre-ANDA logistics and best practices
Kris Andre, MS (OGD/ORS)
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Pre-ANDA review perspectives: Office of Pharmaceutical Quality (OPQ) experience
Suneela Prodduturi, PhD (OPQ/IO)
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Q&A and Panel Discussion View Recording
SESSION 2: Complex Active Pharmaceutical Ingredients (APIs)
Resolving peptide drug challenges through Pre-ANDA processes
Eric Pang, PhD (OGD/ORS)
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Considerations in demonstrating complex API sameness
Deyi Zhang, PhD (OGD/ORS)
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Common issues in complex drug substance review for generic drug products
Jane Chang, PhD (OPQ/OPF)
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Q&A Panel Discussion View Recording
SESSION 3: Complex Formulations/Dosage Forms
Considerations for establishing Q1/Q2 sameness of complex formulations
Bin Qin, PhD (OGD/ORS)
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Considerations and expectations for in vitro release testing of complex formulations
Yan Wang, PhD (OGD/ORS)
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Liposomes: Physicochemical characterization and in vitro drug release testing
Soumyarwit Manna, PhD (OGD/ORS)
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Iron carbohydrate colloid drug products: Characterization and impurity considerations
Yiwei Li, PhD (OPQ/OLDP)
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Application of modeling and simulation in establishing appropriate bioequivalence limits for complex formulations
Satish Sharan, PhD (OGD/ORS)
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Equivalence testing of complex particle size distribution profiles based on earth mover’s distance
Meng Hu, PhD (OGD/ORS)
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Q&A and Panel Discussion View Recording
SESSION 4: Complex Route of Delivery: Ophthalmic
In vitro bioequivalence testing for topical ophthalmic suspension products
Darby Kozak, PhD (OGD/ORS)
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Product quality testing for topical ophthalmic suspension products
Patricia Onyimba (OPQ/OLDP)
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Physiologically-based pharmacokinetic modeling and simulation used in assessing bioequivalence for generic ophthalmic products
Andrew Babiskin, PhD (OGD/ORS)
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Q&A and Panel Discussion View Recording

 
 

Day 2: September 13:

SESSION 5: Complex Route of Delivery/Dosage Forms: Topical and Transdermal
Overview of current science-based regulatory standards
Sam G. Raney, PhD (OGD/ORS)
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Product development considerations for generic topical products
Priyanka Ghosh, PhD (OGD/ORS)
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How to resolve current challenges in ANDAs for topical products
a. Common deficiencies – OPQ considerations

Kelley Burridge, PhD (OPQ/OLDP)
b. Common deficiencies – OGD considerations
Usha Katragadda, PhD (OGD/OB)
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Physiologically-based pharmacokinetic modeling and simulation used in assessing bioequivalence for generic dermatological products
Eleftheria Tsakalozou, PhD (OGD/ORS)
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Q&A and Panel Discussion View Recording
Product development considerations for generic transdermal delivery systems (TDS)
Tannaz Ramezanli, PhD (OGD/ORS)
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How to resolve current challenges with ANDAs for TDS
a. Common deficiencies-OPQ considerations

Robert Berendt, PhD (OPQ/OLDP)
b. Common deficiencies-OGD considerations
Ying Fan, PhD (OGD/OB)
c. Common deficiencies-Statistical considerations
Stella Grosser, PhD (OTS/OB)
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Q&A and Panel Discussion View Recording
SESSION 6: Complex Generic Drug-Device Combination Products and Complex Abuse Deterrent Formulations
Developing generic drug-device combination products: Regulatory considerations for user-interface and the role of comparative analyses
Andrew LeBoeuf, MS, JD (OGD/OGDP)
Kimberly Witzmann, MD (OGD/ORS)
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In vitro and in vivo abuse deterrence evaluation of generic opioid products
Xiaoming Xu, PhD (OPQ/OTR)
Dajun Sun, PhD (OGD/ORS)
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SESSION 7: Complex Routes of Delivery: Orally Inhaled and Nasal Drug Products (OINDPs)
Current product-specific guidances and common questions in pre-ANDA communications
Denise Conti, PhD (OGD/ORS)
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Common bioequivalence deficiencies for orally inhaled drug products in ANDAs
Tian Ma, PhD (OGD/OB)
Michael Spagnola, MD (OGD/OB)
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OPQ’s perspective on quality considerations for generic orally inhaled drug products
Dhaval Gaglani, MS (OPQ/OLDP)
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Batch-to-batch pharmacokinetic variability of orally inhaled drug products
Zhichuan (Matt) Li, PhD (OGD/ORS)
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Computational fluid dynamics (CFD) modeling for product development of generic OINDPs and for supporting novel BE approaches
Ross Walenga, PhD (OGD/ORS)
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Q&A and Panel Discussion View Recording
Panel Discussion: All Topics & Closing Remarks
Robert Lionberger, PhD (OGD/ORS)
Kris Andre, MS (OGD/ORS)
Dale Conner, PharmD (OGD/OB)
Kamal Tiwari, PhD (OPQ/OPF)
Katherine Tyner, PhD (OPQ/IO)
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