Advancing Generic Drug Development: Bioequivalence
Challenges for Patient-Centric Oral Formulations
June 11, 2026
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The field of patient-specialized oral drug formulations continues to evolve, presenting unique bioequivalence (BE) challenges that require innovative regulatory approaches. This workshop is designed to facilitate discussions about the latest advancements and regulatory considerations in the evolving field of patient-centric (including pediatric) generic oral products, addressing product development and regulatory assessment challenges for these important medicines.
Attendees will gain valuable insights into the intricacies of developing generic versions of specialized oral formulations across diverse areas. The scope of discussions will include chewable tablets, orally disintegrating tablets, pellet/granule formulations, suspension products, and sublingual/buccal formulations. This workshop will also address challenges for the development and assessment of generic pediatric-specific formulations designed to meet the unique needs of patient populations with swallowability challenges.
Through a series of expert-led presentations and Q&A sessions, participants will have the opportunity to hear from and pose questions to experts from FDA, to help deepen their understanding of current best practices, challenges and opportunities, regulatory expectations, and emerging trends. Specifically, the workshop will cover critical areas such as regulatory strategies for patient-centric formulations, formulation-specific development issues, regulatory strategies for pediatric formulations, and innovative BE approaches including physiologically based pharmacokinetic (PBPK) modeling to support generic pediatric product development. These topics reflect some of the most challenging issues facing patient-centric oral generic drug development, and the workshop will facilitate a discussion of the scientific and regulatory innovations being deployed to overcome these challenges.
Don’t miss this unique opportunity to learn how to improve your generic drug development!
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Agenda & Speaker Bios
Event Agenda
The event agenda is still being refined and may be updated over time. The current version is v3, uploaded on May 11, 2026.
Speaker Biographies
The speaker biographies document provides detailed information for each of the event presenters.
LOGIN Links
The links below will become active on the day of the event.
The above rooms will open ~15 minutes before each day begins.
If you encounter any technical issues, visit the Technical Issues Support Page
Files & Recordings
Download Presentation Slides
A link for you to download the presentation slides will be added here when they are available.
Event Evaluation & Certificate
A link for you to evaluate the Event and access the online certificate will be added here on the second afternoon of the event.
Session Recordings
Recordings will be linked here as soon as they are available.
Questions & More Information
Continuing Education
Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations.
Certificates are only available during the two weeks post-event (until June 25, 2026).
This event has been pre-approved by:
- RAPS as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
- SOCRA who 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.
- SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
- ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.
Questions?
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