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Digitalisation is already transforming industries and its application in the world of regulatory assessment is on the horizon. Multiple recent efforts have focused on digitalisation and its potential to increase efficiency in submission and review, for both industry and agencies. Initiatives such as Accumulus, data standardization, and the revision of M4Q are all intended to facilitate global harmonization, thereby enhancing submission efficiency, regulatory assessment, and enabling pharmaceutical supply to patients worldwide. This session will focus on several key efforts in this space and will explore the specific activities ongoing in each, as well as reflections from Industry and Regulatory Agencies perspectives.
Session Speakers: EMA Perspectives on ICH M4Q(R2) and Digital Regulatory Assessments Klara Tiitso, EMA-European Medicines Agency, Netherlands
FDA Perspective on Opportunities for Modernization of Regulatory Submissions Ingrid Markovic, CBER, FDA, United States
M4Q ICH Current Status and Vision from Industry Sarah Pope Miksinski, AstraZeneca, United States
The Power of Data Exchange CMC Interoperability and a Cloud-based Ecosystem Michael Abernathy, Amgen Inc., United States