ISPE Announces its 2025 ISPE Pharma 4.0™ Conference Keynote Speakers and Tracks

The 2025 ISPE Pharma 4.0™ Conference, focused on enabling effective digital transformation in operations, will take place from 9–10 December in Barcelona, Spain, and virtually

NORTH BETHESDA, Md., Sept. 30, 2025 /PRNewswire/ -- The International Society for Pharmaceutical Engineering (ISPE) has announced its keynote speakers for the 2025 ISPE Pharma 4.0™ Conference, set for Tuesday, 9 December, through Wednesday, 10 December, in Barcelona, Spain, and virtually.

"The 2025 ISPE Pharma 4.0™ Conference offers a unique opportunity for industry experts, regulators, and professionals from around the world to come together and connect, share resources, and navigate the evolving challenges and opportunities impacting life sciences," said Mike Martin, President and CEO of ISPE. "With increasing industry pressure around cost and efficiency, and growing investments in AI, the event will address how to build credible, validated models for pharmaceutical manufacturing processes. Together, we'll explore risk assessment frameworks, validation strategies, and approaches like the ISPE and GAMP®-related approaches like the 'ISPE GAMP® Guide: Artificial Intelligence.'"

This year's conference will feature eight technical tracks:

• AI Case Studies: Benefits and Challenges 
• Automation and Advanced Robotics 
• Data-Driven Manufacturing Excellence Solutions 
• Data-Driven Quality Decisions 
• Innovative Facility Design 
• Process Analytical Technology (PAT) as an Enabler for Digital Transformation 
• Pharma 4.0™: Preparing for the Future 
• Smart Validation and Quality Assurance (QA) for Smart Technologies: AI and Beyond

ISPE has announced its confirmed keynote speakers for the event:

• Ib Alstrup, Medicines Inspector, GxP IT, Danish Medicines Agency, presenting a regulatory keynote
• Carmen Araujo, Head of Global Quality Audit and Supplier Quality, Takeda, presenting "Strategic AI Integration in GxP Environments: Takeda's Path to Operational Excellence"
• Michelangelo Canzoneri, Global Head of Group Smart Manufacturing, Merck KGaA Darmstadt, Germany, presenting "SMARTfacturing – Shaping the Possible"
• Lena Hinløv, Vice President IT/OT Future Standards, Novo Nordisk, presenting "AIming for Smarter and Faster Operations by One Unified Data Ecosystem"
• Heike Roeder, Vice President Quality Assurance International, Cencora, presenting "From Plant to Patient – Enhancing Patient Access through Digitalization"

Learn more and register for the 2025 ISPE Pharma 4.0™ Conference today by visiting ISPE.org/2025-Pharma-40.

About ISPE
The International Society for Pharmaceutical Engineering (ISPE) is a global nonprofit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 24,000+ members of ISPE provide solutions to complex pharmaceutical industry challenges through innovation, member and workforce development, and technical, regulatory, and compliance collaborations in more than 120 countries worldwide. Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland, USA, and its operations center in Tampa, Florida, USA. For more information, visit ISPE.org.

SOURCE ISPE