Event
Considerations and Potential Regulatory Applications for a Model Master File
Friday, May 3, 2024
8:30 a.m.-4:00 p.m.
Hybrid: The Universities at Shady Grove, Rockville, MD
M-CERSI
cersi@umd.edu
Registration
In-person attendees: please register by April 24, 2024, by 5 PM ET.
You will receive emails from Eventbrite when you register and closer to the workshop with information related to the event including event location (for in-person attendees only) and Zoom link (for virtual attendees only) after you successfully complete registration. Please check your spam if you do not receive the email in your inbox.
Workshop Supplementary Information
The supplementary information document contains additional information on discussion topics for the Small Group Discussion Session (in-person only), MMF proposed definition and two MMF case studies that we will be discussing at the workshop. It also contains additional information from two workshops co-hosted by the FDA and the (CRCG) in the past that introduced and discussed the MMF framework.
About
The purpose of this workshop is to engage stakeholders among model developers, industry, and FDA in a discussion on the concept, scope, and regulatory application of a Model Master File (MMF). The goals of this workshop are to illustrate how MMFs can improve the efficiency with which evidence from modeling and simulation (M&S) can facilitate drug product development. Additionally, the workshop will explore how M&S can increase efficiency in application assessment and consistency in regulatory use and acceptance of established models.
To view additonal information, please view this link
