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Advancing Generic Drug Development:
Leveraging Model-Integrated Evidence (MIE) in the
Development and Approval of Generic Drugs
August 27, 2026

Agenda & Speaker Bios

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Event Agenda

The event agenda is still being refined and may be updated over time. The current version is v3, uploaded on July 21, 2026.

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Speaker Biographies

The speaker biographies document provides detailed information for each of the event presenters.

Files & Recordings

Download Presentation Slides

Download Presentation Slides

Event Evaluation & Certificate

Evaluation & Certificate

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: