This recorded programme is designed for senior pharmaceutical leaders responsible for adopting, overseeing or governing AI and advanced analytics within regulated (GxP) environments.
As regulatory scrutiny of AI continues to increase, it focuses on decision-grade, regulator-aligned implementation - ensuring innovation is deployed safely, credibly and defensibly.
Rather than teaching technical coding or model development, the programme concentrates on governance frameworks, validation expectations, risk-based context-of-use thinking, and cross-functional accountability across Clinical Development, Pharmacovigilance, Quality, Regulatory and Medical functions.
Why This Programme Now
- Increasing regulatory scrutiny of AI use in GxP environments
- EU AI Act and global governance expectations
- Rising internal demand for defensible AI validation frameworks
- Need for decision-grade documentation and oversight models
Key Differentiators
- Explicitly framed around GxP, validation and governance expectations
- Risk-based 'context of use' approach integrated throughout
- Focus on defensible, decision-grade implementation
- Designed for QA, regulatory and governance-led audiences
- Commercially deployable across enterprise environments
Programme Structure
The programme consists of eight on-demand modules (60-75 minutes each) plus an optional live virtual Q&A session. Modules can be taken individually or as a structured certification pathway.
- From Data to Decisions in Pharma - Context of Use & Risk-Based Thinking
- Data Integrity & AI-Ready Foundations in GxP
- Decision-Grade Analytics: Bias, Causality & Defensible Interpretation
- Clinical Development Analytics & Decentralised Trials
- Real-World Evidence & Pharmacovigilance AI
- AI Methods That Matter: Explainability, Federated Learning & Risk Flags
- GenAI for Regulated Documentation & Controlled Authoring
- Validation, MLOps & AI Governance Frameworks
- Live Virtual Q&A: Governance & Implementation Challenges (Optional)*
*For further details on the optional Q&A module, please contact our team. This module is included with the purchase of the group licenses.
Speakers
Dr Laura Brown MBA is an independent pharmaceutical consultant with over 25 years’ experience working across regulated pharma environments. Her work spans clinical development, quality, pharmacovigilance, regulatory and operational teams, supporting senior leaders in making defensible decisions within complex GxP systems.
She has delivered training and advisory programmes to professionals from organisations including Roche, MSD, Novo Nordisk, Bayer, Sanofi, Johnson & Johnson and GSK. Delegates have included Compliance Managers, QA Leaders, Pharmacovigilance Managers, Regulatory Affairs professionals and Medical Governance leads.
Laura recently spoke on Corporate Governance & Policy Frameworks for AI in Trials at a global clinical AI conference, focusing on internal AI oversight, validation alignment and regulator-ready documentation frameworks. She is also a visiting lecturer at Cranfield School of Management.
Tom Brown brings applied AI and data analytics experience, including work with the Bank of England and a six-month engagement with EY focused on AI and data analytics. He has completed formal AI study at the London School of Economics and has delivered AI-focused sessions to pharmaceutical audiences.
Together, the programme combines governance-led decision expertise with applied AI experience in regulated environments.
Who Should Attend
- QA and Regulatory Leaders
- Pharmacovigilance and Clinical Governance Teams
- Compliance and Risk Professionals
- Digital Transformation and AI Oversight Leads
- Cross-functional Senior Leaders overseeing AI adoption
