Thank you to all who made the 2025 ISPE Pharma 4.0™ Conference such a big success!
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Featured Sessions
Navigating Innovation and Regulation – Annex 11 and the New Annex 22
The pharmaceutical industry faces a critical juncture of technological innovation and evolving regulations. Annex 11 updates governance of computerized systems, while Annex 22 introduces guidance for AI and Machine Learning, raising key questions: How far should regulations extend into emerging technologies, and how can compliance align with progress? In this keynote, Ib Alstrup will explore the risks, benefits, and strategic opportunities these annexes present, offering practical insights into their potential impact on pharmaceutical regulation and technology adoption.
Digital Innovation to Enable Operational Excellence
This presentation highlights how Eli Lilly leverages digital innovation to drive operational excellence and supply resiliency. It showcases technologies like virtual reality for aseptic practices, operator training, and error reduction, as well as “release by exception” to accelerate cycle times. AI applications improve defect detection and compliance, while data models monitor operator movement for real-time feedback. These examples demonstrate how digitalization minimizes variability and unlocks full operational potential, emphasizing the need for continued investment in advanced technologies.
SMARTfacturing – Shaping the Possible
Pharma 4.0 is shifting from vision to reality, though adoption remains uneven. In this keynote, Michelangelo Canzoneri, Global Head of Group Smart Manufacturing at Merck KGaA, will share how SMARTfacturing bridges vision and execution, guiding the industry forward. He’ll explore how AI and data-driven operations boost competitiveness and speed patient access, why collaboration and regulatory alignment build trust and scalability, and how workforce empowerment ensures sustainable adoption. Learn how leaders can shape resilient, reliable access to medicines worldwide.
Regulatory and Industry Panel Discussion
The pharmaceutical industry is undergoing a digital revolution powered by AI and machine learning, transforming every stage of the product lifecycle—from R&D and clinical development to manufacturing, quality assurance, and supply chain operations. A key focus is the GMP-regulated segment, where innovation must align with strict safety and efficacy standards. This panel will explore opportunities and limitations of AI/ML in this context, addressing challenges and strategies to foster innovation while maintaining compliance and ensuring patient safety in a rapidly evolving sector.
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