2026 ISPE AI in Life Sciences Summit
Thank you to all who made the 2026 ISPE AI in Life Sciences Summit such a big success!
The 2026 ISPE AI in Life Sciences Summit – Powered by GAMP® will bring together pharmaceutical manufacturers, technology providers, academic scientists, and international regulators to network, share insights, and provide an outlook on artificial intelligence in the life sciences industry.
This conference will focus on the transformative role of artificial intelligence across the life sciences value chain, including drug or device development, clinical research, manufacturing, supply chain management, and post-market surveillance, and covering business, quality, and technology perspectives. The Summit will feature industry and regulatory keynotes and panel discussions sharing high-level perspectives on innovation, strategy, and regulatory expectations.
Conference Attendees
Navigate the conference platform via the listed links.
- On Demand: View conference sessions
- Featured Speakers: View all session speakers
- Attendee Roster: View the full list of conference attendees
- Presentation: Presentations received from speakers before the conference who have agreed to make them available are currently posted on the conference platform.
- Summit Photo Gallery: View Summit Photos
Featured Speakers
Featured Sessions
Sunday Interactive Workshop
The "Supplier Collaboration in an AI and GxP Context – An Interactive Workshop Experience" interactive workshop will put participants into the center stage: We will explore supplier collaboration in a combined AI and GxP context. Participants can decide whether they take the position of the regulated company or the supplier, receive a briefing, prepare their strategy, and come together in a supplier assessment-like situation. In the plenum, teams will share their experiences from the workshop and from real-life situations.
From Lab to Patient: Governing the AI-Driven GxP Pipeline
The life sciences industry faces a challenge as AI-driven discovery accelerates while traditional GxP validation remains crucial. Security must evolve from a static perimeter to a dynamic governance layer that fosters trust. This keynote presents a blueprint for "validated agility," using the Secure AI Framework to meet global regulatory expectations.
AI in Regulated MedTech: What Regulators Expect and Where Manufacturers Fall Short
AI is reshaping the medical device landscape, creating new opportunities and regulatory complexities. This chat will explore evolving expectations from regulators on AI in QMS, SaMD, and medical devices. It will cover common pitfalls in data management, model validation, and cybersecurity, while addressing the convergence of EU MDR and the EU AI Act.
A Look into Industry’s Innovative Digital Regulatory Transformation
The convergence of digital innovation and regulatory science offers a chance to enhance patient access to medicines by rethinking the regulatory ecosystem. New technologies enable real-time, parallel reviews and reduce approval timelines from over four years to under six months, improving global access and focusing on patient-centered outcomes.
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