During the Pharma Meets AI conference in Barcelona in April 2026, discussions highlighted a significant shift in AI governance within the pharmaceutical industry. Moving away from high-level policy frameworks, the focus is now on integrating governance into operational models. As AI adoption grows, it’s no longer a standalone function but is becoming part of core business processes. Kathrin Hahn from Novartis emphasized the need for an “integrated assurance” approach that combines governance, risk management, compliance, and internal controls. This unified framework ensures clear accountability and consistent oversight of AI applications. The responsible use of AI is guided by principles like transparency and ethical deployment, but practical implementation is crucial. This involves embedding AI risk and compliance within business functions, supported by ongoing monitoring and audits. The transition to “AI governance 2.0” represents a cultural shift, where AI is not limited to specialist teams, but engages employees across the organization through training and performance objectives. As AI becomes integral to drug development and commercial activities, embedding governance in everyday operations is essential for balancing innovation with responsible use.

