About the Event:

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.

The MMF is a framework aimed at model-sharing and model-reusability. Similar to drug master files, MMFs can be referenced by multiple applications for a similar purpose of use, thus improving model sharing, model standardization, and regulatory consistency and efficiency. Quantitative models which include, but are not limited to, physiologically based pharmacokinetic models, population pharmacokinetics models, and mechanistic in vitro in vivo correlations may be developed as MMFs. Discussions are essential on practical aspects and best practices for MMFs that are included in regulatory submissions with modeling and simulation approaches.

The workshop will discuss the concept, scope, and operational aspects for MMF implementation in regulatory submissions. The workshop will engage experts from the FDA, new and generic drug developers, academic institutions, contract research organizations (CROs), consultants and others involved in drug product development to improve understanding of the role of MMFs in supporting drug product development and enhancing regulatory consistency and efficiency. The workshop will also allow all interested parties to coordinate and collaborate toward the implementation of model integrated evidence (MIE) to increase efficiency in drug product development and to streamline drug product approval.

Virtual Attendees will have free access to all sessions of the workshop except the small group working sessions. They will be able to:

Attend all presentations and panel discussions
Participate in all Q&A panel discussions by submitting questions online in real time to the speakers and panelists
Enjoy free access to workshop recordings of presentations and panel discussion (not including the working sessions)

In-Person Attendees will play an active part in advancing the role of MMF in regulatory submissions by:

Collaborating in person with FDA and industry experts to inform best practices for developing, validating, implementing and submitting MMFs in support of M&S approaches that support drug product development and regulatory approvals throughout the workshop, and particularly during small group working sessions at the end of Days 1 and 2 of the workshop
Developing a clear understanding of the concept, scope, and operational aspects of MMFs
Engaging in dialogue with attendees and faculty about the challenges and benefits of MMFs contained in regulatory applications for industry, CROs, consultants, and regulatory agencies
Conversing with panelists during discussion panel Q&As
Networking with colleagues during breaks with light snacks and beverages, and catered lunches

Workshop Topics:

Understanding of the MMF framework and discussing challenging aspects of MMF development and implementation in regulatory submissions
Considering best practices for the development and application of MMFs in drug development and regulatory submissions for generics and brand name products
Exploring opportunities for standardizing model sharing in the generic and new drug space
Discussing case studies that illustrate how MMFs can be leveraged within the scope of successful MIE and model informed drug development (MIDD) approaches to support drug product development and regulatory approval
Deliberating about how the MMF framework can enhance the regulatory use and acceptance of M&S approaches

Audience:

This workshop is primarily developed for the generic and new drug industry and associated collaborators, including consultants and CROs whose work supports new and generic drug applications.

Virtual Attendance is optimal for an audience that is interested in an introduction to the concept of a MMF, and in understanding the potential benefits of integrating model-based evidence in regulatory submissions through the MMF framework.
In-Person Attendance is optimal for an audience that is invested in actively engaging with the FDA, industry colleagues, representatives from CROs and consultants to develop best practices related to utilizing MMFs in support of regulatory submissions, discussing how challenges related to developing and submitting MMFs can be addressed, and sharing insights about how MMFs can enhance regulatory submissions and improve regulatory acceptance for M&S approaches.

Registration:

This workshop is FREE for virtual attendees. The combined cost for both days of in-person attendance and activities is $500 and will cover event-related expenses.

In-person attendees: please register by April 24, 2024 by 5 PM ET.

For faculty and students from the University of Maryland, Baltimore; Universities at Shady Grove; and University of Michigan, the workshop is free for in-person attendance. Please contact us (info@complexgenerics.org) and indicate which workshop you are interested in.

Continuing education (CE) credits will not be provided for attending this workshop. A certificate of attendance will only be provided to individuals attending the workshop in-person.

Photography, Audio, and Video Recording:

This is a public event and photography, audio, and video recording will take place. By entering this event, you understand that you may be photographed, filmed, and/or otherwise recorded, and these images may be published for use on, but not limited to, websites, social media, news, and advertising in connection with the CRCG program. Registering for this event constitutes acknowledgment of this statement.

Considerations and Potential Regulatory Applications for Model Master File