Events & Insights

Giskard Consulting had a successful exhibition at Future Labs Live Basel 2026, joining the Startup Village to discuss pharma automation practices and the technologies reshaping regulated manufacturing.

One shift was impossible to miss: the industry has stopped debating whether AI works. The conversation has moved to safety, integration, and scale. AI literacy on the floor was exceptionally high: whether tools are adopted or in active experimentation, the technical foundation is firmly in place.

The keynotes revealed where the real work is happening:

• Structural Productivity — scaling AI across pharma operations without losing process consistency.
• Proactive Governance — making AI usage demonstrably safer without paralysing innovation.
• Ecosystem Connectivity — moving from isolated experiments to connected, governed digital ecosystems.

Companies headlining the event included NVIDIA, Roche, Novo Nordisk, GSK, Siemens, and Nestlé.

The hard truth: innovation without validation is a liability. The organisations pulling ahead are building compliance foundations first, automation second. For Pharma QA and Digital Transformation leaders, the challenge is no longer technical adoption — it is building the governance architecture fast enough to match the pace of deployment.

Spent four days in London with my Quantic EMBA cohort — finally meeting the real faces behind the alumni network. Learning and workshopping together takes networking to another level and builds genuinely fruitful connections.

The Global Conference covered a remarkable range of frontier technology — Quantum Computing, Space, applied AI, and the future of defence technology.

Three keynotes stood out:

• Prof. Dr. Patrick Glauner's keynote mapped where AI is already disrupting industries and where real organisational opportunities lie.
• Robert Steele Ph.D went deep into applied AI in high-pressure, high-consequence environments.
• Marc Lindner closed with a session on innovation, ethics, and defence technology that made the room go quiet.

The thread connecting all of it: we are racing ahead of our own governance frameworks. The models are getting faster, more autonomous, and more consequential — and the regulatory architecture designed to oversee them is struggling to keep up. That is not a criticism. It is the defining puzzle of this decade.

A pattern emerged across multiple vendor conversations at Tech Show London. The technology was sophisticated — autonomous AI systems, cloud-native cybersecurity, multi-tenant data infrastructure operating across jurisdictions.

But when the conversation turned to EU market operations and data handling, the framing was consistent: "We don't store data directly." "We operate as middleware." "We handle metadata, not the records themselves." Every statement technically defensible. None of them regulatory safe.

Under EU MDR and the EU AI Act's supply chain obligations, the question is not whether your vendor stores data — it is whether they orchestrate any part of the pipeline that feeds a regulated output. If they do, they sit inside your compliance boundary, regardless of how they classify themselves. This is the blind spot I see consistently across scaling MedTech and Digital Health companies: the software supply chain is mapped for functionality, not for regulatory exposure.

"If you're in the data path, you're in scope — regardless of "middleware" labels."

A highly focused conference organised by the EOQ MNB Pharmaceutical Committee in Budapest, exploring the rapidly evolving intersection of technology and Quality Assurance in the pharmaceutical industry.

Key sessions covered the EU AI Act's specific technical requirements embedded within the legal text — including "Security-by-Design" and "Risk-Aware Engineering" as presented by EY. The NNGYK (Hungarian National Public Health and Drug Authority) and industry experts addressed approaches to AI validation under EU GMP Annex 22. The Hungarian National AI Strategy (2025–2030) roadmap provided valuable local context on how national regulation is aligning with European standards.

Speakers represented NNGYK, EY, WIL-ZONE, hello-ai, Teva Pharmaceuticals, Egis Pharmaceuticals, and Sanofi — covering everything from large language models to the Pharma Factory of the Future. The balance between AI automation and human oversight is where Quality Assurance professionals will define their value in the coming decade.

ISPE Ireland Affiliate brought together the pharmaceutical and biotech sectors — alongside the HPRA, Ireland's Health Products Regulatory Authority — to explore the real-world impact of new regulations, particularly CSA and AI guidance.

Practical use cases were presented by AbbVie, MSD, and Astellas Pharma, showcasing AI systems in production, cloud-based MES deployments, and shop floor equipment integration. Orise demonstrated new approaches to automated Audit Trail review. EIS presented OpsTrakker's role in enhancing efficiency and traceability in regulated environments. Notably, the HPRA used its platform to actively welcome this dialogue between manufacturers and frontier-technology service providers — a regulator keen to build a shared view of what is coming and how to stay compliant.

Networking sessions connected ISPE affiliates, Pharma 4.0 Ireland, GAMP UK, and solution providers in genuinely collaborative discussion. Updates on the ISPE Digital Validation Guide and forthcoming AI guideline releases rounded out a forward-thinking programme — a clear indicator of where the GxP validation discipline is heading.