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#368: Perspectives on the Adoption of Advanced Manufacturing Technologies
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
143ABC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-664-L04-P; CME 1.00; RN 1.00

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 Objectives

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.

Chair

Evdokia Korakianiti, PhD, MSc

Speaker

Implementation Journey for AI use in Manufacturing (without hallucinating)
Gert Thurau, DrSc, PhD

Implementation Journey of a Digital Twin
Benjamin Stevens, PhD, MPH

mRNA-Based Vaccines: From First Approvals Towards a Platform Technology
Brian Doyle


Speakers
avatar for Brian Doyle

Brian Doyle

Senior Director, Technical Development, Moderna, United States
Brian Doyle has over 15 years of experience in technical and CMC development for vaccines and therapeutics. Since joining Moderna in 2019, Brian has led organizations focused on late-stage and commercial process development and CMC technical writing, with a particular interest at... Read More →
avatar for Evdokia Korakianiti

Evdokia Korakianiti

Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
Evdokia joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which includes Quality, GxP Compliance, Referrals and PhV. She is the EMA lead of the EU Network's strategic priority to facilitate the uptake of advanced manufacturing approaches. She... Read More →
avatar for Benjamin Stevens

Benjamin Stevens

Director CMC Policy and Advocacy, GlaxoSmithKline, United States
Ben Stevens is a Director of CMC Policy and Advocacy at GlaxoSmithKline and has nearly 15 years of drug discovery and regulatory experience. Prior to GSK, Ben was a Director of Regulatory Affairs CMC at Alnylam, a Principal Consultant at PAREXEL and an acting Branch Chief in the Office... Read More →
avatar for Gert Thurau

Gert Thurau

Head of CMC Regulatory Policy for Manufacturing Technology Innovation in, F. Hoffmann-La Roche Ltd, Switzerland
Dr. Gert Thurau is the Head of Manufacturing Technology and Innovation Advocacy in the CMC Reg PTR Policy team at Hoffmann- La Roche in Basel, Switzerland. His responsibility includes the regulatory advocacy for the adoption of advanced technologies in GMP manufacturing – covering... Read More →
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
143ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session

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