2026 ISPE Pharma 4.0™ and Biopharma Conference

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