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2019 Complex Generic Drug Product Development Workshop
September 25-26

Sally ChoeAs a continuation from the 2018 workshop on complex generic drug products, the goal of this science-focused workshop is to communicate to the generic industry how FDA research outcomes guide and facilitate complex generic drug product development. FDA will link GDUFA science and research on complex products to product-specific guidance development, discuss pre-ANDA meetings and review, and examine various areas of complex product science.

Keynote Speaker:
Sally Choe
Director of the Office of Generic Drugs

Full Agenda

Continuing Education Credit

  • This two-day conference has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
  • This event has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • ACRP provides continuing medical education for the completion of this educational activity. Contact hours are provided at 1 unit for at least 45 minutes of qualified material.
  • SOCRA accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area.
  • Attendance is required for attendance certificates which are only available during the two weeks after the event.
  • CME | CPE | CNE will NOT be provided for this event.
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
    View Recording
  • Pre-ANDA Program Update – Karen Bengtson & Suneela Prodduturi
    View Recording
  • FDA’s Inactive Ingredient Database: Improvements on the Path to 2020 – Susan Zuk
    View Recording
  • Q&A and Panel Discussion
    View Recording
  • Research Activities, Scientific Advances, & Modernization of Bioequivalence Standards for Generic Topical and Transdermal Products – Sam Raney
    View Recording
  • Innovation and Harmonization of Bioequivalence Standards for Generic Topical and Transdermal Products – Priyanka Ghosh
    View Recordin
  • Best Practices & Efficient Strategies for Generic Topical Product Development – Tannaz Ramezanli
    View Recording
  • Critical Quality Considerations for Transdermal Delivery Systems – Brock Roughton
    View Recording
  • Q&A and Panel Discussion
    View Recording
  • Characterization and Comparative Evaluation Strategies to Demonstrate Complex API Sameness – Deyi Zhang
    View Recording
  • Complex Peptide ANDAs: Test and Reference Product Comparability Studies from a Quality Perspective – Cameron Smith
    View Recording
  • Development, Characterization, and Evaluation Considerations of Particle Analysis to Support Generic Product Quality and Bioequivalence Determination – Xiaoming Xu
    View Recording
  • Q&A and Panel Discussion
    View Recording
  • Bioequivalence Approaches for Long Acting Drug Products: Regulatory and Scientific Considerations – Yan Wang
    View Recording
  • Characterization and Comparative Evaluation Strategies to Demonstrate Complex Excipient Sameness – Bin Qin
    View Recording
  • Considerations on In Vitro Drug Release Testing for Long Acting Drug Products for Quality Control Purpose – Vidula Kolhatkar
    View Recording
  • Q&A and Panel Discussion
    View Recording

Day Two:

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

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More Information

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