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Perspectives on the Adoption of Advanced Manufacturing Technologies
Session Chair(s)
Evdokia Korakianiti, PhD, MSc
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)
Implementation Journey of a Digital Twin
Benjamin Stevens, PhD, MPH
GlaxoSmithKline, United States
Director CMC Policy and Advocacy
Implementation Journey for AI use in Manufacturing (without hallucinating)
Gert Thurau, DrSc, PhD
F. Hoffmann-La Roche Ltd, Switzerland
Head of CMC Regulatory Policy for Manufacturing Technology Innovation in
Enabling Regulatory Frameworks to Foster Innovation - Regulatory Perspective
Marcel Hoefnagel, DrSc, PhD, MSc
Medicines Evaluation Board , Netherlands
Senior Assessor Biopharmaceuticals
mRNA-Based Vaccines: From First Approvals Towards a Platform Technology
Brian Doyle
Moderna, United States
Senior Director, Technical Development
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