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Articles and analysis from our own work across GxP, pharma, quality management, GAMP and AI - what is changing in the regulated environment, what it means in practice, and what is happening inside our company.

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Events, case studies and insights.

19th Official GAMP 5 Conference - December 8–9, 2026, Mannheim

On December 7, 2026 in Mannheim, Oliver Herrmann (QFINITY) – together with Jens Lambertz and Martin Heitmann – leads the official GAMP 5 pre-conference introductory training, the compact warm-up to the 19th GAMP 5 Conference, covering the fundamentals of risk-based CSV per GAMP 5 Second Edition and an outlook on AI.

The official GAMP 5 pre-conference introductory training takes place on Monday, December 7, 2026 in Mannheim – the kick-off to the 19th Official GAMP 5 Conference (December 8-9). A joint event of ISPE, APV, Concept Heidelberg and VDI/VDE-GMA.

QFINITY as trainer

Oliver Herrmann leads the training together with Jens Lambertz and Martin Heitmann and covers the fundamentals of risk-based validation of computerized systems per GAMP 5 Second Edition – with a focus on CSV basics and placing artificial intelligence in the regulated environment.

  • Risk-based CSV per GAMP 5 Second Edition
  • From the fundamentals to practical application
  • Placing AI in the regulated GxP environment

Built from the foundation up – risk-based validation made clear for newcomers.

Program and registration at the organizer (gamp-dach.de)

QFINITY beim 5. ACDM AI Symposium 2026 in London - KI in klinischen Studien und Datenmanagement

On June 23 and 24, 2026, QFINITY participated in the 5th Annual ACDM AI Symposium in London – a gathering of experts from pharmaceutical companies, CROs, and technology providers on the growing role of artificial intelligence in clinical trials and clinical data management.

QFINITY participated in the 5th Annual ACDM AI Symposium, which took place on June 23 and 24, 2026, in London. The symposium brought together experts from pharmaceutical companies, CROs, and technology providers to discuss the growing role of artificial intelligence in clinical trials and clinical data management.

Over the course of two days, experts shared practical use cases and implementation strategies and offered perspectives on the adoption of AI across the entire clinical development process. The focus was on data quality, governance, and regulatory requirements – as well as the responsible integration of AI into clinical research workflows.

For QFINITY, the symposium was an opportunity to exchange ideas with industry peers, strengthen existing partnerships, and explore how AI-supported solutions can support more efficient and compliant clinical data management.

QFINITY auf dem 5. ACDM Symposium zu KI in klinischen Studien 2026 in London

QFINITY will be attending the 5th ACDM Symposium on Artificial Intelligence in Clinical Trials (June 23-24, 2026, London) – represented by COO Marcus Schwabedissen, who will co-moderate the panel discussion “Turning AI into Impact: Real-World Applications in Clinical Data Management.”

QFINITY will be attending the 5th Annual ACDM Symposium on Artificial Intelligence in Clinical Trials, taking place on June 23-24, 2026, in London. The symposium brings together experts from pharmaceutical companies, CROs, and technology providers to discuss the current and future role of AI in clinical trials. The focus is on practical insights, real-world case studies, expert discussions, and opportunities for exchange on topics such as agentic AI, AI strategies, practical implementation experience, and the next phase of AI in clinical trials.

QFINITY will be represented by Marcus Schwabedissen, COO and Consultant at QFINITY. With his extensive experience in GxP-regulated life sciences and IT environments, computerized system validation, IT quality management, risk management, and regulatory compliance, he brings a practice-oriented perspective on the responsible and compliant use of AI-supported systems in regulated environments.

Together with Jennifer Duff and Tim Armitage, Marcus Schwabedissen will co-moderate the panel discussion “Turning AI into Impact: Real-World Applications in Clinical Data Management.” The focus is on where AI already creates real value in clinical data management today, where implementation remains challenging, and which organizational, technical, and regulatory prerequisites are needed to translate the potential of AI into measurable impact.

For QFINITY, the symposium is an important opportunity to exchange with international experts and discuss practical approaches to AI governance, validation, data integrity, and lifecycle management – and how AI can be used in regulated environments in a controlled, risk-based, and auditable way.