Webinar for Stakeholder Engagement on the New Final Guideline on General Principles for Model-Informed Drug Development (ICH M15) October 29, 2026

https://www.fda.gov/drugs/news-events-human-drugs/webinar-stakeholder-engagement-new-final-guideline-general-principles-model-informed-drug?utm_medium=email&utm_source=govdelivery On October 29, 2026, the U.S. Food and Drug Administration (FDA), in collaboration with the International Council for Harmonisation (ICH), will host a webinar entitled “Stakeholder Engagement on the New Final Guideline on General Principles for Model-Informed Drug Development (ICH M15).” 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.” At this webinar, members of the ICH M15 Expert Working Group will: (1) describe the concepts introduced in the M15 final guideline and facilitate timely adoption to streamline new drug development and regulatory interaction; (2) address common questions on applying the general principles introduced by the guideline; (3) obtain feedback to aid the development of additional training materials and case examples. More information about this event can be found on the Webinar for Stakeholder Engagement on the New Final Guideline on General Principles for Model-Informed Drug Development (ICH M15) web page. For more information about this event or to submit questions, please contact DPM-CONTACT@fda.hhs.gov. https://www.fda.gov/drugs/news-events-human-drugs/webinar-stakeholder-engagement-new-final-guideline-general-principles-model-informed-drug?utm_medium=email&utm_source=govdelivery