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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
There are lots of exciting developments and innovations for biopharma products and processes that have the potential to transform healthcare treatment and delivery…
The EFPIA Biomanufacturing Working Group is a cross-company industry team working to aid the development of biological products for patients. Through areas of special interests, the group supports and develops cutting edge science and technology strategies…
To meet the demands of increasingly complex medicinal products, technologies like mass spectrometry are needed – also in a QC lab. However, for methods like MAM by LC-MS and HCP by MS little experience on how to handle mass spectrometry in a QC lab is currently available…