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

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2019 Complex Generic Drug Product Development Conference
September 25-26

This event is FREE to attend

The Hotel at the University of Maryland – College Park, Maryland
or attend Virtually Online

Norman E. As 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:
Norman E. “Ned” Sharpless, MD
Acting Commissioner of Food and Drugs

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Topics Include:

  • Pre-ANDA program update
  • FDA’s inactive ingredient database: improvements on the path to 2020
  • Scientific and regulatory advances for generic topical and transdermal product development
  • Characterization of complex injectable active pharmaceutical ingredient API and formulations
  • Bioequivalence approaches for complex injectable API and formulations
  • Complex drug-device combination products – injectable products
  • Complex drug-device combination products – orally-inhaled and nasal drug products
  • Quantitative methods and modeling-informed regulatory decision making

Full Agenda

Who Should Attend?

Scientists, researchers, and regulatory affairs professionals who work on or are interested in working on the development of complex generic drugs.

Learning Objectives

After this workshop, participants will be able to:

  • Explain various mechanisms and processes that industry can use to obtain advice from the FDA to facilitate complex generic drug product development; and
  • Summarize new developments in science, guidance, and review experience for specific types of complex generic drug products.

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 3, uploaded on September, 2019.

PDF Download
Speaker Biographies

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

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Onsite Attendance Information

VenueImage of the ballroom in The Hotel at UMD

The Hotel at the University of Maryland (thehotelumd.com)
7777 Baltimore Avenue, College Park, Maryland 20740
Phone: 301-277-7777

Conference is in Ballroom A

Hotel Room Block Information

You may reserve your guest room within the FDA Complex Generic Product Workshop room block using this link or by calling THE HOTEL’s reservations line at 844-954-6835. The discounted rate of $169 will expire on September 9, 2019 or when the block is filled, whichever comes first, so please book your rooms now. You will be responsible to reserve and pay for your own room accommodations. Please be mindful of the hotel’s policy regarding cancellations and early checkout.

Transportation & Parking

Please view the hotel’s Transportation page for transportation and parking information.

Networking Opportunity

A networking opportunity is available for on-site attendees during the conference. The networking event will be held in the Lobby Bar at the hotel. This is an optional self-pay event.

Recording Disclosure

This event will be recorded and made available to the public after its conclusion. Any information shared publicly by participants during the event will become part of that recording. This includes the verbal questions and answers sessions.

For Reasonable Accommodations

If special accommodations at the workshop are needed due to a disability, please email [email protected] at least 7 days in advance of the workshop date. Requests for sign language interpretation or Computer Aided Realtime Translation (CART)/captioning should be made 2 weeks in advance of the workshop and should be sent directly to the FDA Interpreting Services Staff email account: [email protected]

Virtual Attendance Information

Please register to attend virtually if you are unable to travel to College Park, MD to attend in-person. The virtual conference will be hosted via Adobe Connect and is limited to 2,000 simultaneous attendees (1,000 each in Room One and Room Two). If a room is full when you attempt to enter, please try the other room. The recordings of each of the sessions will be posted on the Past Events page within 24 hours.

The links below to the Adobe Connect room for each track will be activated shortly before the event begins.

The above rooms will open 15 minutes before each day begins.

Randomly pick whichever Room you prefer.   Please do not join both rooms at the same time.

The audio for the event will be provided through your computer speakers via Adobe Connect (there will NOT be a teleconference number to dial into). We recommend that you test your PC or mobile device prior to the event and you join the event a few minutes early to address any issues.

To test your PC, please visit:

https://concerted.adobeconnect.com/common/help/en/support/meeting_test.htm

Files, Certificate & Recordings

The ZIP files above will be available for download 24 hours before the event.

Link to Final Evaluation & Certificate of Attendance

The above link will become active at the conclusion of the event.

Session Recordings:

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

Day One:

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

Day Two:

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

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Questions & More Information

Questions?

Please refer the FAQs page on this website. If you are not able to find your answer there, please email us at [email protected].

More Information

If you have questions regarding the content of the event or other CDER-specific information, please: