Considerations and Potential Regulatory Applications for a Model Master File Workshop May 2-3, 2024

https://www.complexgenerics.org/education-training/considerations-and-potential-regulatory-applications-for-a-model-master-file/?utm_medium=email&utm_source=govdelivery Considerations and Potential Regulatory Applications for a Model Master File Workshop May 2-3, 2024 FDA, model developers, and industry will discuss the concept, scope, and regulatory application of a Model Master File. FDA will illustrate how model master files can improve the efficiency with which evidence from modeling and simulation can facilitate drug product development. Additionally, presenters will explore how modeling and simulation can increase efficiency in application assessment and consistency in regulatory use and acceptance of established models.