Co Chair
Senior Business Developer
Bilthoven Biologicals
Conference Overview
10 - 11 Dec 2026 Berlin, Germany and Virtual
The 2026 ISPE Pharma 4.0™ and Biopharma Conference brings together pharmaceutical and biopharmaceutical manufacturers, technology partners, academic experts, and global regulators to explore what’s next and how to make it real.
This year focuses on turning digital ambition into operational impact across the entire value chain. Expect practical insights on automation, AI and machine learning, digital twins, and advanced modelling, with real examples of how to build scalable, resilient, future-ready manufacturing.
A major theme is strengthening the fundamentals that make transformation stick: data readiness, governance, system architecture, and integration to enable true interoperability, especially in legacy and brownfield environments, while staying aligned with GAMP® principles and ensuring digital continuity from design through operations.
Regulatory expectations are evolving fast. Dedicated sessions will cover data integrity, digital evidence, inspection readiness, smart validation, and risk-based assurance for AI-driven systems, offering practical guidance to accelerate innovation while maintaining compliance and trust.
For the first time, the Pharma 4.0™ and Biopharma conference topics are brought together in a single program. This creates a focused space for advanced therapeutics such as cell and gene therapy, ATMPs, and mRNA, and for how digital capabilities can enable faster time to market, lower cost of goods, and scalable manufacturing for high-variability processes. You will also hear perspectives on process intensification, continuous manufacturing, and modular or decentralized models.
Beyond technology, the program is built around real-world case studies, measurable business value, supply chain resilience, and the human factor, from upskilling and operator enablement to change management in increasingly digital organizations.
Participants will leave with more than inspiration: actionable strategies, lessons learned, and real-world examples they can apply immediately
Featured Speakers
Justify your attendance to the 2026 ISPE Pharma 4.0™and Biopharma Conference
Use this letter to help you communicate the value of attending the 2026 ISPE Pharma 4.0™ and Biopharma Conference. Show your employer how your participation will support your professional development, expand your expertise, and provide valuable takeaways for your team.
Your Conference Experience
Expo Hall
Expo Hall
Explore groundbreaking innovations and network with industry leaders at our dynamic expo hall.
Professional Training
Professional Training
Courses present exercises that use current problems and situations common to the industry.
Live Streams
Live Streams
Experience the conference from anywhere with our interactive live stream.
Keynote Speakers
Keynote Speakers
Subject matter experts and top leaders in the pharmaceutical industry.
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50
Speakers
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7
Networking Hours
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18
Education Hours
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40
Exhibitors
Unlock your potential with Continuing Education!
Invest in your future! Join us at the 2026 ISPE Pharma 4.0™ and Biopharma Conference to enhance your skills, share ideas, connect with peers, and earn 1.8 CEUs. Start your journey towards lifelong learning and career advancement today!
Conference Highlights
Pharma 4.0™ in Action: Real-World Examples of AI, Digital Twins, and Automation in Biopharma Manufacturing
A decade after Pharma 4.0™ began reshaping discussions around digital transformation in the pharmaceutical industry, organizations are increasingly focused on implementation. The conversation has evolved beyond vision and strategy to a more practical question: What does Pharma 4.0™ look like in day-to-day biopharmaceutical manufacturing operations?
How Pharma 4.0™ Supports Inspection-Ready Compliance at the 2026 ISPE Pharma 4.0™ and Biopharma Conference
How can pharmaceutical companies achieve inspection-ready digital compliance in the Pharma 4.0™ era? As manufacturers adopt artificial intelligence (AI), connected manufacturing systems, advanced analytics, cloud platforms, and digital quality processes, regulatory compliance must be built into operations from the beginning rather than addressed after implementation. Successful Pharma 4.0™ initiatives depend on trusted data, strong governance, cybersecurity, quality oversight, and systems designed to meet evolving regulatory expectations.
One Mission, Two Strengths: Why the ISPE Conference in Berlin Brings Pharma 4.0™ and Biopharma Together
The industry has spent a decade talking about digital transformation. The conversation is no longer about whether to transform, but about how to do it in a way that holds up — technically, operationally, and in front of a regulator. That shift in maturity is what the 2026 ISPE Pharma 4.0™ and Biopharma Conference, 10–11 December in Berlin, is built to address.
International Program Committee
Co Chair
DT Lead TechOps & Quality
Argenx
Board Liason
SVP Global Engineering, EHS & Sustainability
GSK
WiP Liason
GMDP Quality Auditor & Quality Manager
GMP Check
Executive Industry Advisor
Körber Pharma Software GmbH
Director, Life Sciences
BW Design Group
Senior Director, Global Quality Compliance
BioNTech US Inc.
Senior Fellow - Digital Technology, Associate
CRB
Digital Strategy Delivery Specialist
Roche
Engineering Automation Solutions Director
GSK
Emerging Leader
Process Engineer MS&T Drug Substance
Takeda
SVP, Head of Global CMC Development
Merck KGaA
Emerging Leader
Process Engineer
Castus Sterile Systems
Emerging Leader
Project Advisor
Aseptic Mind
Emerging Leader
Independent
Zauner Consulting
Corporate Partners
