ISPE Announces its 2025 ISPE Pharma 4.0™ Conference Keynote Speakers and Tracks
02 October, 2025
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
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”