FDA/CRCG Workshop: Considerations and Potential Regulatory Applications for a Model Master File
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  • Rockville, MD
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FDA/CRCG Workshop: Considerations and Potential Regulatory Applications for a Model Master File
Co-hosted by the FDA and the Center for Research on Complex Generics (CRCG)

Dates and Times: 

  • May 2nd from 8:30 am – 5:35 pm
  • May 3rd from 8:30 am – 3:50 pm

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 in the context of long acting injectables
Presenter: Daniela Silva, Scientist II
Date: Thursday, May 2nd, 2024
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.


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

Presenter: Viera Lukacova, Chief Science Officer
Date: Thursday, May 2nd, 2024
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.