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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 AG, 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)
Demetra Macheras, MBA
Director, Regulatory Policy and Intelligence - Regulatory Affairs, AbbVie, United States
Introduction
Grzegorz (Greg) Podrygajlo, PHD
GRA CMC Director, Head of Global Manufacturing Support , CSL Behring AG, Switzerland
Application of AI Tools to Support the Decision Process in Regulatory CMC
Gert Thurau, PHD
Head of CMC Regulatory Policy for Manufacturing Technology Innovation in , F. Hoffmann-La Roche Ltd, Switzerland
Use of AI and ML in Pharmaceutical Manufacturing: Case Studies from the Shop Floor and Regulatory Landscape
Hubert Niewiadomski, PHD
Chief Executive Officer, CLEDAR Sp. Z O.O., Poland
How to Use GenAI in a Smart Way for Now and for the Future
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