Flemming Arnø
Generative AI in GxP: Separating Signal from Noise
What’s real, what’s hype, and what’s next? In this fast-paced session, Flemming Arnø cuts through the buzz around AI and Generative AI, clarifying what these technologies actually are, a bit about where they come from and how they fit into today’s digital innovation landscape. You’ll get a clear picture of where the market stands, what use cases are emerging, and how to think about GenAI in a regulated GxP context. With sharp insights, concrete use cases, and a practical dose of do’s and don’ts, this talk is designed to help leaders navigate the intersection of compliance, digital transformation, and how to view AI as a part of the larger IT and digitization strategy.
Bio
Flemming Arnø is a seasoned expert with 30 years of experience in IT and management consulting. He has held key roles at leading organizations including IBM, Gartner, Danske Bank, and Zangenberg & Company. Today, he works independently, specializing in IT and digital strategy, organizational & process design, project management, and IT governance. Flemming is a sought-after speaker across both public and private sectors, especially where AI and Generative AI are high on the agenda.
Contact
Email: flemming@arnoeconsult.dk
Phone number: +45 5353 8075
Jesper Wagner
Building the Foundations for AI in GxP Environments
Before AI can transform the Life Science Industry, the foundations must be in place. In this session, Jesper Madsen Wagner, Expertise Director at NIRAS, takes you behind the buzz to focus on the real prerequisites for responsible AI in regulated environments.
You’ll learn why success depends not just on models, but on:
- Deep domain and process knowledge to frame AI use cases correctly.
- Reliable data availability and quality as the bedrock for compliant AI.
- A clear view of regulatory requirements—from validation to lifecycle oversight.
Rather than asking “What can AI do?”, this talk asks “What must we do first?” It provides practical guidance for building a digital and compliance foundation that turns AI into a trustworthy tool for life sciences.
Bio
Jesper Madsen Wagner is Expertise Director at NIRAS with more than 25 years of experience in quality, automation, and regulatory compliance in the life sciences industry. He has led global audits and projects under ISO 13485, EU MDR, and MDSAP, and advises companies on digital transformation and data utilization in GxP environments. Jesper is a board member of IDA Life Science and part of the ECA Qualification & Validation Expert Group.
Contact
Email: jew@niras.com
Phone number: +45 31447518
Valentin Ioan Dascalescu
Foundation for AI Modelling: from first pilot to validated, scalable value in GxP
Most AI initiatives stall not because the model is “wrong,” but because the foundations are missing: clean, contextualised data; a reusable platform; validation-by-design; and financial and operational guardrails. In this session I will present a pragmatic blueprint for building those foundations so AI models can earn trust, pass audit, and scale in regulated (GxP) environments. We will demystify the split between model work and the non-model effort (data, tooling, process), show where foundations unlock step-change outcomes (e.g., 40% faster regulatory submissions; 50%+ faster DB locks; 70% fewer manual queries), and outline a product-platform operating model that avoids one-off pilots.
Bio
Valentin Ioan Dascalescu is a project & strategy consultant specialising in AI-enabled transformation and CAPEX delivery in regulated industries. An engineer (MSc Mechanical Engineering) with a Trinity College Dublin MBA, he leads end-to-end programmes from concept and validation through execution and governance. His recent experience spans NIRAS and HENKEL, with deep expertise in strategy development, business development, validation and regulatory compliance. For this event, he focuses on “Foundation for AI Modelling” building audit-ready, model-centric foundations that scale safely in GxP.
Contact
Email: info@e1engd.com
Phone number: +353 863762405
Mads Nielsen
Clinical AI, Danish Health Data and drug side effect estimation with AI:
PHAIR (Pharmacovigilance by AI Real-time Analyses) aims to enhance drug safety by enabling faster, more systematic detection of adverse side effects using artificial intelligence. The project integrates AI algorithms and pattern recognition with large-scale Danish health data—including patient records, national registers, and patient-reported outcomes—to monitor real-time medication effects. We use modern AI architectures and patient trajectory foundation models to estimate treatment effect and side-effect from Danish health data. I will go through the organisatorical, ethical, technical aspects and demonstrate preliminary results.
Bio
Mads Nielsen has and M.Sc. in Computer Science and Ph.D. in Image Analysis from University of Copenhagen. He has done research in the mathematical foundation of image analysis, computer vision, medical image analysis, and the foundation of quantitative imaging biomarkers and their use in epidemiology.. He has published more than 300 research papers, graduated more than 45 Ph.D.s and is currently principal investigator on research grants for 100 MDKK+. Currently he is professor at Department of Computer Science, University of Copenhagen, Pioneer Centre for AI, and CEO and co-founder of Biomediq A/S, and co-founder of Aiomic, Cerebriu, Prenaital.
Khaled Taj
Beyond Shadow AI: Turning Uncontrolled Use into Audit-Ready Copilots
Shadow AI is already in enterprise workflows. This session presents the 4G Framework (Guard, Govern, Guide, Gate) to convert ad hoc AI use into governed, auditable LLM copilots for document and workflow tasks. Essential controls are mapped to common compliance expectations (e.g., SaMD/GxP, ISO, GDPR) and integrated into existing quality and risk systems to reduce exposure and deliver measurable ROI within weeks.
Bio
Khaled Taj is a Software Risk Manager at WSAudiology and creator of the 4G Framework for AI governance. With over a decade across regulated industries—from drug GMP at Novo Nordisk to various CE marked devices—he develops practical, audit ready governance workflows for high risk environments.
Contact
Email: khaledtaj@mail.com
Phone: +45 27294739
Bo Olsen
Validation and AI – Practical examples of how AI can improve efficiency, compliance and speed Digitalization of Validation Processes has been available to Life Sciences for some time. Many Life Sciences have still not adopted Validation Lifecycle Management Systems.
However, further advance, the adoption ValGenesis have developed AI capabilities, that increase speed, compliance and efficiency. We will show some practical examples of how AI can help Validation Engineers or QA in their daily work of handling validation.
Bio
Bo Olsen is Global Head of Partner Management and work closely together with NIRAS and other partners to digitize validation processes. Prior, to working for ValGenesis, Bo has held various position at NNIT A/S
Contact
Email: bo.olsen@ValGenesis.com
Phone number: +45 5384 5114
Anuj Chadha
From Black Box to Glass Box: Building Transparent AI for Regulated Life Sciences
As artificial intelligence moves from experimentation into production in regulated life science environments, the critical question shifts from what AI can do, to whether it can be trusted. This session explores how determinism, auditability, and compliance form the backbone of trustworthy AI in GxP contexts. Anuj Chadha, Co-CEO of Alchemi Bio, will share practical strategies for ensuring AI systems produce reproducible outcomes, maintain transparent audit trails, and align with both EU and international regulatory expectations across the product lifecycle. Attendees will gain insights into balancing innovation with compliance, building AI that is not only powerful but also reliable, explainable, and inspection ready.
Bio
Anuj Chadha is a scientist and engineer with a background spanning Caltech and a master’s degree at Harvard. He has worked at the intersection of robotics and AI, including time at Vecna Robotics, where he focused on building deterministic and reliable intelligent systems. As Co-CEO of Alchemi Bio, he now applies this expertise to life sciences, developing transparent, auditable, and compliant AI solutions for regulated environments. Anuj is driven by the goal of making AI both innovative and trustworthy in critical applications.
Contact
Email: anuj.chadha@alchemi.bio
Phone number: +626-977-5485