Shaping the regulated quality of tomorrow.

Oliver Herrmann will serve as Track Lead for the GAMP track at the ISPE Europe Annual Meeting 2026 in Copenhagen: ‘Digital Compliance by Design.’ The call for presentations is open – we welcome submissions on AI, cloud, data integrity, and digital validation in a GxP context.

Oliver Herrmann to Lead GAMP Track at ISPE EU Annual Meeting 2026 in Copenhagen – Call for Presentations Now Open

QFINITY is proud to announce that our Managing Director, Oliver Herrmann, will serve as Track Lead for the GAMP Track at the ISPE Europe Annual Meeting 2026 in Copenhagen this December.

Compliance by Design means building conformity into processes and systems from the start – enabling innovation without compromising GxP.

Track Title:

Digital Compliance by Design: GAMP, AI, Data Integrity & Digital Validation in a Digitized World

The life sciences industry is undergoing a profound digital transformation. Cloud-based platforms, AI-powered tools, and intelligent automation are reshaping how we develop, validate, and operate systems. These technologies bring tremendous opportunities – but also new risks, expectations, and regulatory demands.

This track will explore how to put Compliance by Design into practice – embedding it into processes, systems, and technologies from the start and enabling innovation without compromising GxP compliance.

A special focus will be on data integrity as the foundation for AI: without trustworthy, high-quality, and well-governed data, AI systems cannot function reliably – especially in regulated environments.

Call for Presentations – Submit Now!

We invite regulators, industry experts, solution providers, and thought leaders to submit proposals on:

• Compliance by Design in Practice – implementing AI, cloud, and automation in line with GxP and regulatory expectations
• Applying GAMP 5 Second Edition, the GAMP AI Guide, and the Digital Validation Guide in digital initiatives
• Annex 11 vs. Annex 15 – clarifying overlaps and distinctions for QA, IT, and project teams
• Data Integrity in the Digital Era – particularly in the context of AI
• Translating process requirements into risk-based, testable, and GxP-compliant system requirements
• Supplier qualification and continuous oversight in outsourced or cloud environments
• Business continuity and disaster recovery for regulated digital infrastructures

We particularly welcome case studies, lessons learned, collaborative approaches, and forward-looking insights on emerging technologies and future regulatory expectations.

👉 Submission deadline: 17th October 2025
👉 More information & submissions: https://ispe.org/conferences/2026-europe-annual-conference 

QFINITY – Connecting Compliance & Innovation
With Oliver Herrmann as Track Lead, we’re shaping the future of digital compliance in pharma – digital by default, compliant by design.