Location: In person (at The Universities at Shady Grove; Rockville, MD) and virtual workshop.

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.

Presentations

Model master file for oral dosage forms: Important considerations and potential applications

Presenter: Viera Lukacova, Chief Science Officer
Date/Time: Thursday, May 2nd, 2024 from 11:55 am – 12:10 pm
Session 3: MMF Applications for Long-Acting Injectable Drug Products
Format: Presentations and a Panel Discussion Q&A (Virtual and In-Person Attendees)

This session will offer case studies and discussions about situations in which an MMF can support product development and regulatory submissions for long-acting injectable drug products.

Model master file in the context of long acting injectables
Presenter: Daniela Silva, Scientist II
Date/Time: Thursday, May 2nd, 2024 from 2:45 PM – 3:00 PM
Session 2: MMF Applications for Oral Drug Products
Format: Presentations and a Panel Discussion Q&A (Virtual and In-Person Attendees)

This session will offer case studies and discussions about situations in which an MMF can support product development and regulatory submissions for oral drug products.