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As pharmaceutical companies increasingly explore artificial intelligence to support CSV, industry experts are emphasizing that success depends not on blind trust in AI, but on understanding where it adds value and where human oversight remains indispensable. These themes will be explored at the 2026 ISPE Annual Meeting & Expo, where Frank Henrichmann, Senior Executive Consultant at Q-Finity will discuss the opportunities and risks associated with incorporating AI into validation workflows.

ISPE has announced its planned keynote speakers for its largest event of the year, the 2026 ISPE Annual Meeting & Expo. The conference will take place from 18–21 October in Washington, D.C., USA, and virtually.

As pharmaceutical companies face mounting pressure to validate increasingly complex digital systems with limited resources, artificial intelligence is emerging as a valuable tool for streamlining validation activities. The topic will be a focal point at the 2026 ISPE Annual Meeting & Expo, where Louie Rayal, Vice President of Governance, Risk, and Compliance at GSK, will discuss how AI can support validation programs while preserving the risk-based decision-making and human accountability required in regulated environments.

As cell and gene therapies (CGT) continue to push the boundaries of personalized medicine, traditional quality management system (QMS) approaches are being tested by the unique challenges of early-stage development. These issues will be a key topic at the 2026 ISPE Annual Meeting & Expo, where Andrew Cieri, Executive Director of Quality within Regeneron’s Cell Medicines unit, will share lessons learned from integrating a Phase 1 CGT program following a corporate acquisition.

As pharmaceutical companies seek to leverage generative artificial intelligence within regulated environments, retrieval-augmented generation (RAG) is gaining attention as a practical approach for balancing innovation with compliance. The topic will be explored at the 2026 ISPE Annual Meeting & Expo, where data integrity expert Ulrich Köllisch, Founder of UMK Consulting, will discuss how organizations can validate and govern RAG systems operating in GxP environments.

As pharmaceutical manufacturers explore ways to integrate artificial intelligence into regulated operations, industry leaders are emphasizing that successful adoption depends as much on governance and risk management as it does on technology. These themes will be a key focus at the 2026 ISPE Annual Meeting & Expo, where Pfizer's Director of Engineering Validation, Arif Azad, will discuss practical approaches for deploying AI solutions in Good Manufacturing Practice (GMP) environments while maintaining compliance, data integrity, and patient safety.

ISPE has announced Jose Caraballo-Oramas, Executive Chair, Founder, and Principal, JCO Global Advisory LLC, as the Executive Chair of the 2026 ISPE Annual Meeting & Expo. ISPE has also announced Connie Langer, Regulatory Intelligence Lead – Pharma Quality, Safety, and Environmental Operations of Pfizer, as Conference Chair.