FDA 关于 ICH M15《模型引导药物开发通用原则》最终指南的利益相关方参与网络研讨会（2026年10月29日）

Webcast | Virtual

Event Title

Webinar for Stakeholder Engagement on the New Final Guideline on General Principles for Model-Informed Drug Development (ICH M15)

October 29, 2026

Date:

October 29, 2026

Time:

8:30 a.m. - 10:00 a.m. ET

Attend the Live Webinar

Pre-recorded Presentations

About This Event

Adopted by the International Council for Harmonisation (ICH) in February 2026, the new ICH M15 guideline, “General Principles for Model-Informed Drug Development,” provides general recommendations for planning, model evaluation, and documentation of evidence derived from model-informed drug development (MIDD). This guideline establishes a harmonized assessment framework (including associated terminology) for MIDD evidence.

In June 2026, FDA implemented the ICH M15 guideline by issuing the final guidance for industry titled “M15 General Principles for Model-Informed Drug Development.”

This webinar presents the final M15 guideline, explaining the concepts introduced in the guideline, illustrating them through a case example, and addressing common questions about applying these principles.

This event includes two separate sessions:

• Pre-recorded presentations illustrating concepts and principles introduced by the ICH M15 guideline
• A live webinar on October 29, 2026, for broader engagement with scientists in the MIDD community

Workshop Objectives

• Describe the concepts introduced in the M15 final guideline and facilitate timely adoption to streamline new drug development and regulatory interaction
• Address common questions on applying the general principles introduced by the guideline
• Obtain feedback to aid the development of additional training materials and case examples

Meeting Information

There is no cost to attend, and registration is not required. For more information about this event or to submit questions, please contact DPM-CONTACT@fda.hhs.gov.