Advancing Generic Drug Development (AGDD) 2026:
Bioequivalence Challenges and Approaches of
Patient-Centric Oral Formulations
June 11, 2026
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The annual Generic Drugs Forum is a two-day event designed to facilitate the development and approval of safe, effective, and high-quality generic medicines. This premier event brings together FDA subject matter experts from every aspect of the pre-ANDA and ANDA assessment programs, offering unparalleled insights and guidance.
Attendees will gain practical regulatory knowledge to enhance their applications, streamline the assessment process, and reduce cycles. The forum’s primary goal is to support prospective and current applicants in submitting complete and high-quality submissions, ultimately ensuring timely access to affordable medications that benefit public health.
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Agenda & Speaker Bios
Event Agenda
The event agenda is still being refined and will be posted here when it is complete.
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
The links above will become active on the day before the event begins.
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?
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
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