Workshop | Virtual

Event Title

Advancing Generic Drug Development: Leveraging Model-Integrated Evidence (MIE) in the Development & Approval of Generic Drugs

August 27, 2026

Date:: August 27, 2026
Time:: 8:30 a.m. - 12:30 p.m. ET

This virtual event is FREE!

Agenda

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About this Event (Hosted by CDER SBIA)

This workshop will be hosted virtually on Adobe Connect. Registration information coming soon.

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, learn practical strategies for avoiding common pitfalls, and hear real-world case studies demonstrating how MIE has successfully supported FDA guidance development and generic drug approvals.

Intended Audience

Scientists, researchers, current and prospective generic drug applicants, regulatory affairs professionals, and modelers who work on or have an interest in the use of quantitative modeling and simulation approaches to support the development and approval of generic drug products.

Topics Covered

An overview of MIE submissions received by FDA and key takeaways for the field.
Up-to-date regulatory expectations and lessons learned for population pharmacokinetics (popPK) modeling, locally-acting physiologically based pharmacokinetic (PBPK) modeling, and oral PBPK modeling in generic drug submissions.
The role of MIE in shaping FDA product-specific and general guidance development across a range of drug products, including orally inhaled drug products, long-acting injectables, ophthalmic drug products, and oral drug products.
An update on the ICH M15 guidance on “General Principles for Model-Informed Drug Development”.

Learning Objectives

Stay up to date with the latest advancements in QM science, MIE methodology, FDA guidance recommendations, and regulatory perspectives related to generic drug products.
Learn how to structure MIE submissions effectively and avoid common mistakes identified by FDA assessors.
Understand how MIE approaches have been successfully applied to support generic drug development and approval.

Continuing Education (CE)

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.

This course 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.

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