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

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This half-day workshop includes a series of expert-lead presentations and audience Q&A sessions focused on the latest advancements and regulatory considerations in the evolving field of Model-Integrated Evidence (MIE)-supported generic drug development and approval.

The use of quantitative medicine (QM) approaches to support the development and approval of generic drug products continues to evolve rapidly. When combined with all available in vitro and in vivo evidence, these approaches constitute MIE, a holistic framework that FDA and industry are increasingly leveraging to establish bioequivalence for generic drug products.

Attendees at this workshop will gain valuable insights into FDA’s regulatory expectations for MIE submissions, practical strategies for avoiding common pitfalls, and real-world case studies demonstrating how MIE has successfully supported FDA guidance development and generic drug approvals.

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Agenda & Speaker Bios

PDF Download
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.

PDF Download
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.

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: