Advancing Generic Drug Development:
Modernizing Bioequivalence Approaches for
Topical & Transdermal Products
September 10, 2026
View Start Time on World Clock
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!
Click Here for Details
Agenda & Speaker Bios
Event Agenda
The event agenda is still being refined and may be updated over time. The current version is v4, uploaded on August 4, 2026.
Speaker Biographies
The speaker biographies document provides detailed information for each of the event presenters. It is under development and will be added as soon as it is ready.
LOGIN Links
The links below will become active on the day of the event.
Login One
Ability to submit questions
Cannot pause or rewind
Limited to 1,000 seats
Use Login Two if this room is full
Login Two
Ability to pause or rewind
Cannot submit live questions
Unlimited Seating
Livestream Direct
Use this if you encounter issues
with the other links
Your attendance will NOT
be tracked in our system
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 September 10, 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?
Please refer the FAQs page on this website. If you are not able to find your answer there, please email us at info@sbiaevents.com.
If you have questions regarding the content of the event or other CDER-specific information, please:
- Visit the CDER SBIA website
- Learn more about CDER SBIA Workshops and Webinars
- Subscribe to the CDER SBIA email updates
- Follow us on LinkedIn