The event is organized by CDER (Center for Drug Evaluation and Research) and the discussion will be of some interest to the combination products & medical device communities as reliance on in silico tools (including AI and physics-based modeling) increases.
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.
