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Pharmaceutical Companies Face Growing Pressure to Govern AI in Regulated Environments

globenewswire.com

Pharmaceutical Companies Face Growing Pressure to Govern AI in Regulated Environments Dublin, May 19, 2026 (GLOBE NEWSWIRE) -- The "Decision-Grade AI in GxP Environments: Governance, Validation and Regulator-Aligned Implementation" training programme has been added to ResearchAndMarkets.com's offering.

As pharmaceutical companies accelerate the deployment of artificial intelligence across clinical development, regulatory affairs, pharmacovigilance and quality operations, the governance and validation challenges associated with AI adoption in regulated environments have become a growing operational priority.

Investment in AI across pharmaceutical and biotechnology organisations has accelerated sharply in recent years, particularly within clinical operations, regulatory workflows and medical information functions. At the same time, regulators globally are increasing their focus on AI oversight, explainability, validation and accountability, particularly where AI systems may influence regulated decisions, documentation or workflows.

The EU AI Act, alongside broader expectations around transparency, auditability and risk management, is driving demand for structured governance frameworks across the life sciences sector. Recent concerns surrounding AI hallucinations, opaque decision-making and insufficient oversight have further highlighted the importance of governance and validation within GxP environments.

In response, Research and Markets now offers Decision-Grade AI in GxP Environments: Governance, Validation and Regulator-Aligned Implementation, a recorded executive training programme designed specifically for senior pharmaceutical and life sciences leaders responsible for overseeing or governing AI within regulated environments.

The programme focuses not on technical coding or model development, but on the governance, validation and cross-functional accountability challenges faced by QA, regulatory and compliance leaders when deploying AI in practice. Its risk-based, context-of-use approach is designed to support regulator-ready implementation across Clinical Development, Pharmacovigilance, Quality, Regulatory and Medical functions.

The programme consists of eight on-demand modules of 60 to 75 minutes each, with an optional live virtual Q&A session available to group licence holders. Modules may be taken individually or as part of a structured certification pathway.

Topics covered include:

The programme is led by Dr Laura Brown MBA, an independent pharmaceutical consultant with more than 25 years’ experience across clinical development, quality, pharmacovigilance, regulatory and operational environments. She has delivered training attended by professionals from organisations including Roche, MSD, Novo Nordisk, Bayer, Sanofi, Johnson & Johnson and GSK, and has spoken on AI governance and policy frameworks within regulated environments. Dr Brown is also a visiting lecturer at Cranfield School of Management.

Co-leading the programme is Tom Brown, an applied AI and data analytics specialist who has delivered AI-focused sessions to pharmaceutical audiences and completed AI-related executive study at the London School of Economics.

“AI adoption within pharmaceutical organisations is accelerating rapidly, but many firms are still developing the governance structures needed to support compliant and defensible use of these technologies in regulated environments,” said Ross Glover, CEO of Research and Markets.

“As regulators increase their focus on explainability, validation and oversight, life sciences organisations are under growing pressure to ensure that AI-assisted processes can withstand scrutiny during audits and inspections. We expect AI governance and validation to become one of the defining operational challenges for regulated industries over the next several years.”

The programme is targeted at QA and Regulatory leaders, Pharmacovigilance and Clinical Governance teams, Compliance and Risk professionals, Digital Transformation and AI Oversight leads, and senior cross-functional executives responsible for AI adoption.

Licences are available for individual delegates, teams of up to five, and groups of up to fifteen, with on-demand access provided via a secure online platform.

For more information about this training programme visit https://www.researchandmarkets.com/r/muy5p3

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