ISPE EU Annual Conference 2026

Meet QFINITY on site at the ISPE EU Annual Conference 2026 in Copenhagen and learn how digital compliance, AI, and GxP requirements can be brought together in a safe, future-proof, and practical way.

Event: ISPE EU Annual Conference 2026
Location: Copenhagen, Denmark, and virtual
Date: April 20–22, 2026
Organizer: International Society for Pharmaceutical Engineering
QFINITY Role: Program Team & Track Lead Digital Compliance

QFINITY’s Contribution to ISPE Europe 2026

The digital transformation of the pharmaceutical industry is progressing rapidly. Artificial intelligence, cloud technologies, and data-driven automation are now integral parts of GxP-critical processes. At the same time, regulatory requirements for data integrity, transparency, and patient safety remain uncompromising.

Oliver Herrmann, CEO of QFINITY, is a member of the event’s Program Team. In addition, together with Josef Trapl and Niels de Blende, he serves as Track Lead for the Digital Compliance track. In this role, he is responsible for the structure, technical depth, and overall content direction of the track.

Content Focus: Digital Compliance

The Digital Compliance track addresses one central question:

How can GxP compliance be sustainably ensured in AI-enabled, cloud-based, and continuously evolving system landscapes?

1. GxP Principles in the Age of AI

Risk-based application of GAMP® principles to AI systems
Compliance-by-design for automation and cloud architectures
Clear accountability for automated decisions

2. From Document-Based to Data-Driven Validation

Digital, record-based validation approaches
Inspection-ready, data-centric evidence
Scalable Validation 4.0 models

3. Data Integrity, Trust, and Decision-Making

Practical data integrity concepts
Audit trail design and review in complex GxP landscapes
Traceable models for AI-supported review by exception

4. Next Generation Digital Compliance

End-to-end validation of AI systems
Intelligent agents and embedded compliance
Explainability as the foundation of regulatory trust

For further information about the event and registration for the ISPE EU Annual Conference, please visit the ISPE website.