15 OCT
VIRTUAL EVENT

Scilife Quality
Summit 2026

Scilife Quality Summit 2026 brings together QA leaders across life sciences to explore what AI adoption really looks like in regulated environments.

Overview

The future of quality –
AI-driven, human-led

Explore what compliant AI adoption looks like in regulated environments and how life sciences teams can move forward while expectations continue to evolve.

✧

Why this Summit, why now: AI is transforming quality and raising new questions about transparency, accountability, and oversight. Join QA leaders, regulators, and auditors to explore compliant AI adoption in life sciences.

What to expect

Where AI adoption
meets governance

As AI enters quality workflows, how should it be governed across validation, traceability, and reliance—and where must responsibility stay human?

✧

What you’ll leave with: You’ll gain a clear view of the key questions in AI for quality today: what human-in-the-loop really means, where regulations stand, what current FDA and EU guidance for model accountability clarifies, and what is still uncertain.

Interactive panels
and keynotes

Hear directly from experts applying AI in life sciences, covering validation, inspection readiness, data integrity, and how to get reliable results in practice.

Insightful
workshops

Learn how to implement AI in quality while maintaining traceability and compliance, with practical approaches you can use immediately.

Practical oversight
frameworks

Turn “human-in-the-loop” from theory into practical oversight and build governance that aligns with FDA guidance for AI credibility and EU GMP Annex 22.

Topics in focus

What’s on the quality table

12:00 CET
6:00 EST

AI Governance and Validation: The Orchestrator Approach

Martin King and Sachin Bhandari explore how to govern, validate, and monitor AI in regulated environments. Learn how to classify AI by risk, define its intended use, build inspection-ready validation, and establish the governance needed to use AI with confidence while meeting evolving regulatory expectations.

Martin Cranston King is a Regulatory Affairs and Quality Assurance Expert Consultant with over 40 years of experience in medical devices, IVD, pharmaceuticals, and regulatory compliance. A BSI-trained Lead Auditor and recognized LinkedIn Top MedTech Leading Voice, he helps organizations navigate global quality and regulatory challenges while sharing expert insights on the evolving regulatory landscape.

Sachin Bhandari is a Quality IT and Digitalization leader with 25+ years of pharmaceutical experience. He specialises in computer system assurance (CSA), AI validation, enterprise eQMS, and digital quality transformation, and serves on the GAMP Global Steering Committee.

13:45 CET
07:45 EST

The missing link between root cause analysis and effective CAPAs

Discover why many root cause investigations fail to prevent recurring issues. Learn how stronger critical thinking leads to more effective CAPAs, where AI can support investigations, and how to identify the true causes behind quality events instead of treating symptoms.

Kurt In Albon is the Founder and Principal Consultant at INK Pharma Consult LLC, bringing over 30 years of experience in pharmaceutical IT, quality assurance, validation, and data governance. After starting his career at Lonza, he went on to help global life sciences organizations strengthen quality data governance and digital quality systems. Today, his work focuses on data integrity, information governance, and advancing patient safety through trusted healthcare data.

14:45 CET
08:45 EST

Building quality culture in the age of AI: Leadership, collaboration and responsible decision-making

As AI and digital transformation reshape life sciences, quality must evolve beyond compliance. Natalia will explore how leadership, collaboration, and human-centric quality help build stronger quality cultures, enabling QA to become a trusted business partner that supports innovation and responsible decision-making.

Natalia Vtyurina, PhD, is Founder and Chair of the ISPE Netherlands Quality Community of Practice. With expertise in advanced therapies, quality operations, and digital transformation, she champions human-centric approaches in quality that position quality as a driver of business success.

16:00 CET
10:00 EST

When innovation and regulation move together

AI can only deliver on its promise if organisations can trust the data behind it. Danny explores how European regulation is evolving to support responsible AI adoption through trusted data ecosystems, human oversight, quality governance, and evidence-based decision-making.

Danny Van Roijen is an EU policy expert with 20 years of experience in European regulation, digital health, and AI policy. A former member of the European Commission's expert groups on eHealth and cybersecurity certification, he specialises in trustworthy AI, health data governance, and digital health innovation.

17:00 CET
11:00 EST

From gatekeeper to strategic partner: How early quality involvement drives better decisions and reduces risk

As AI and digital technologies reshape pharma, quality must be involved from the start. Marta will share how early quality involvement reduces risk, strengthens compliance, and helps QA become a strategic partner that supports better business decisions and innovation.

Marta Rodríguez Vélez is Head of Corporate Quality at LETI Pharma, with over 20 years of experience in biopharma. She specializes in GxP compliance, digital transformation, and risk-based quality management, and is an active contributor to organizations including AEFI, PDA Spain, and ISPE.