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#437: Opportunity, Caution or Reluctance: Global Trends for Regulating AI in Pharmaceutical Manufacturing
Monday June 15, 2026 2:30pm - 3:30pm EDT
118C
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Application UAN: 0286-0000-26-533-L04-P; CME 1.00; RN 1.00

Artificial intelligence is revolutionizing drug manufacturing, yet regulations are still catching up. With key guidance from the EU and US in development, a proactive and collaborative approach is needed for global regulatory alignment, ensuring AI i

Learning Objectives

Identify and summarize regulatory trends specific to AI use in Manufacturing; Distinguish AI use in manufacturing from use in product development.

Chair

Gert Thurau, PHD

Speaker

PMDA regulatory perspectives on AI in Manufacturing
Yoshihiro Matsuda, DrMed

Case Study Industry applications of AI
Thomas O'Connor, PHD

FDA regulatory perspectives on AI in Manufacturing
Tina Kiang, PHD


Speakers
avatar for Tina Kiang

Tina Kiang

Director, Division of Regulation and Guidance, OPPQ, OPQ, CDER, FDA, United States
Tina Kiang, Ph.D. currently serves as the Director of the Division of Regulation and Guidance in OPQ/OPPQ. She has over 20 years of combined regulatory and leadership experience at the FDA. Tina has led and supervised the development and finalization of guidance and regulations on... Read More →
avatar for Yoshihiro Matsuda

Yoshihiro Matsuda

Senior Scientist (for Quality), Pharmacist, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Matsuda is a pharmacist and a Principal Senior Scientist for Quality at the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. He received his Bachelor of Pharmaceutical Sciences from Toho University in 1997 and his Master’s degree from Toyama Medical and Pharmaceutical... Read More →
TO

Thomas O'Connor

Director Process Analytics, GSK, United States
Tom is a director for process analytics at GSK. His team develops models to accelerate process development and increase the robustness of commercial manufacturing. Tom joined GSK from the FDA where he was the deputy director of the Office of Pharmaceutical Quality Research in the... 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 →
Monday June 15, 2026 2:30pm - 3:30pm EDT
118C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  07: RegCMC-Product Quality, Session |   03: Data-Tech-AI, Session
  • Audience Advanced
  • Area Artificial Intelligence
  • Level Advanced
  • format csv
  • Credit Type ACPE, CME, RN
  • Feature Topics Artificial Intelligence
  • Interest Area Quality Assurance / Control & CMC,Health Technology & AI
  • Tags Session

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