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Revolutionizing Regulatory CMC and Advanced Manufacturing with the Power of AI: Unleashing Innovation and Efficiency
Session Chair(s)
Grzegorz (Greg) Podrygajlo, PhD
GRA CMC Director, Head of Global Manufacturing Support
CSL Behring, Switzerland
This forum session will explore the transformative potential of Artificial Intelligence (AI) in biotech RA CMC and advanced manufacturing. Discover how AI can optimize processes, improve efficiency, and ensure compliance of your data.
Learning Objective : Define key concepts and principles of artificial intelligence (AI) in the context of biotech industry, regulatory CMC and advanced manufacturing; Identify the potential applications and benefits of AI including how it can automate deviation and change control processes or support strategic decision-making; Discuss the benefits, challenges and cons of AI i.e. data integrity and security.
Speaker(s)
Introduction
Demetra Macheras, MBA
AbbVie, United States
Director, Regulatory Policy and Intelligence - Regulatory Affairs
Application of AI Tools to Support the Decision Process in Regulatory CMC
Grzegorz (Greg) Podrygajlo, PhD
CSL Behring, Switzerland
GRA CMC Director, Head of Global Manufacturing Support
Use of AI and ML in Pharmaceutical Manufacturing: Case Studies from the Shop Floor and Regulatory Landscape
Gert Thurau, DrSc, PhD
F. Hoffmann-La Roche Ltd, Switzerland
Head of Manufacturing Technology Innovation in CMC Regulatory Policy
How to Use GenAI in a Smart Way for Now and for the Future
Hubert Niewiadomski, PhD
CLEDAR Sp. Z O.O., Poland
Chief Executive Officer
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