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Perspectives on the Adoption of Advanced Manufacturing Technologies
Session Chair(s)
Evdokia Korakianiti, PharmD
Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
Share regulatory efforts to support advanced manufacturing, including global regulatory developments from EMA and FDA; Listen to Industry cases studies showing implementation journeys and interactions with Regulators globally. Describe avenues available to industry and academia to support development of advanced manufacturing technologies; Discuss remaining challenges and priority areas for Industry and Regulators to work collaboratively to promote the adoption of advanced manufacturing technologies.
Learning Objective : Discuss regulatory efforts to support advanced manufacturing, including global regulatory developments from EMA and FDA; Describe avenues available to industry and academia to support development of advanced manufacturing technologies; Discuss priority areas for regulatory consideration to promote the adoption of advanced manufacturing technologies.
Speaker(s)
Benjamin Stevens, PhD, MPH
Senior Director, Regulatory Affairs CMC Policy and Advocacy, Alnylam Pharmaceuticals, Inc., United States
Implementation Journey of a Digital Twin
Gert Thurau, PhD
Head of CMC Regulatory Policy for Manufacturing Technology Innovation in , F. Hoffmann-La Roche Ltd, Switzerland
Implementation Journey for AI use in Manufacturing (without hallucinating)
Marcel Hoefnagel, DRSc, PhD, MSc
Senior Assessor Biopharmaceuticals, Medicines Evaluation Board , Netherlands
Enabling Regulatory Frameworks to Foster Innovation - Regulatory Perspective
Brian Doyle
Senior Director, Technical Development, Moderna, United States
mRNA-Based Vaccines: From First Approvals Towards a Platform Technology
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