FDA CDER SBIA 将于2026年8月27日举办“推进仿制药开发：在仿制药开发与批准中运用模型整合证据（MIE）”线上研讨会
Advancing Generic Drug Development: Leveraging Model-Integrated Evidence (MIE) in the Development & Approval of Generic Drugs - 08/27/2026
FDA CDER SBIA 将于2026年8月27日8:30-12:30 ET举办线上研讨会，聚焦模型整合证据（MIE）支持仿制药开发与批准的最新进展与监管考量。会议将介绍FDA收到的MIE申报概况，以及群体药代动力学（popPK）、局部作用PBPK和口服PBPK建模的监管预期与经验教训。议题还涵盖MIE在口腔吸入、长效注射、眼科及口服药品指南制定中的作用，并更新ICH M15指南进展。
Workshop | Virtual
Event Title
Advancing Generic Drug Development: Leveraging Model-Integrated Evidence (MIE) in the Development & Approval of Generic Drugs
- Date:
- August 27, 2026
- Time:
- 8:30 a.m. - 12:30 p.m. ET
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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.
FDA Resources
来源：FDA 官方药品与生物制品信息 · fda.gov