Artificial Intelligence is rapidly transforming the way GxP-regulated organizations operate, offering new possibilities for efficiency, decision support, and advanced analytics across the product lifecycle. From quality and manufacturing to pharmacovigilance and clinical operations, AI-enabled solutions are increasingly being explored and, in some cases, implemented in regulated environments. At the same time, the use of AI in GxP operations raises important regulatory questions. Authorities expect patient safety, product quality, and data integrity to remain paramount—regardless of the level of automation or intelligence involved. Concepts such as validation, transparency, accountability, and change control must be reinterpreted in light of adaptive and data-driven technologies. This Break-out session focuses on the regulatory perspective of AI in GxP operations. It explores how existing GxP principles, guidelines, and expectations apply to AI-based systems, what regulators are emphasizing today, and where organizations need to be particularly cautious. The goal is to provide a practical understanding of how innovation with AI can be balanced with compliance, risk management, and regulatory trust.
Speaker: Chris Reid