The CEO Playbook for Enterprise AI: Where Governance Shows Up in the P&L

8:35 AM – 9:05 AM  |  Chairperson Welcome & Opening Address 

How governance decisions directly affect approvals, margin, and the speed at which AI scales across the enterprise.

Key Takeaways:

• The financial impact of validation and inspection readiness

• What boards expect before approving AI at scale

• Moving from pilots to enterprise-ready AI

Owning the AI Lifecycle: Cutting Validation Timelines & Turning Compliance into Advantage 

9:05 AM – 9:40 AM  |  Executive Keynote

How leaders shorten validation cycles and embed governance without slowing AI deployment.

Key Takeaways:

• Governance models that reduce validation time

• Modernizing GxP frameworks for AI

• Designing inspection-ready systems by default

Refreshments & Curated Networking

9:45 AM – 10:45 AM  |  Operator Exchange: Trusted Solutions & Real-World Implementations

Direct conversations with partners deploying AI in regulated environments — focused on implementation realities, not demos.

From Policy to P&L: Turning AI Governance into Enterprise Accountability

10:50 AM – 11:30 AM  |  Executive Leadership Panel Discussion

How organizations move beyond Responsible AI statements to governance models that drive accountability and performance.

Key Takeaways:

• Structures that accelerate innovation while protecting approvals

• Accountability models that scale across functions

• Embedding trust into execution, not just policy

Operationalizing AI at Enterprise Scale: Speed, Compliance & Advantage

11:30 PM – 12:05 PM  |  Industry Collaborator Session

How enterprise governance is built into daily operations so inspection readiness becomes a byproduct of execution, not a last-minute effort.

Key Takeaways:

• Institutionalizing AI oversight across sites

• Governance mechanisms that prevent deviations and rework

• Executive readiness and performance metrics

Inside the Audit Room: How Regulators Assess AI 

1:15 AM – 1:50 AM  |  Case Study Keynote

A former regulator explains how inspectors evaluate AI programs and why leadership ownership and traceability matter most.

Key Takeaways:

• What regulators prioritize during inspections

• Documentation that signals control and confidence

• A real-world recovery playbook that preserved approvals

The Business Case for Trust: The Real ROI of Validated AI

1:50 PM - 2:30 PM  |   Executive Leadership Panel Discussion 

How validated AI improves profitability, inspection outcomes, and investor confidence.

Key Outcomes

• How trust impacts inspection readiness and margin

• Why validation is treated as a value driver, not overhead

• What investors prioritize before funding AI initiatives

Where Humans Still Own the Call: Designing AI Accountability

2:30 PM – 3:05 PM  |  Industry Collaborator Session

How leaders define decision rights and human oversight as AI scales across the enterprise.

Key Takeaways:

• Oversight models regulators trust

• Clear decision rights across functions

• Accountability frameworks that support performance

Mid-Day Drinks Reception & Curated Networking

3:10 PM – 4:10 PM  |  Sip, Connect & Collaborate

A curated reception focused on live initiatives, deployment realities, and next-step partnerships.

Global AI Regulation 2026–2028: What Leaders Must Prepare for Now

4:15 PM – 4:50 PM  |  Afternoon Keynote

What upcoming regulatory expectations from FDA, EMA, and Health Canada mean for enterprise AI today.

Key Takeaways:

• Immediate actions leaders must take

• What inspection-ready systems look like in practice

• Where regulatory risk is emerging

Governance as Strategy: How Validated AI Becomes Market Advantage

4:50 PM – 5:25 PM  |  Closing Case Study

How governance has become a competitive signal that drives customer trust, investor confidence, and disciplined execution.

Key Takeaways:

• Why governance influences buying decisions

• Trust indicators customers and investors watch

• Embedding accountability across the enterprise

Chairperson Closing Reflections — From Trust to Transformation

5:25 PM – 5:35 PM  |  Closing Address

A synthesis of Day 1 insights into an enterprise roadmap for scalable, inspection-ready AI.

The Trust Lounge 

5:45 PM – 7:15 PM  |  Evening Networking Reception 

As sessions conclude, the summit floor transitions into The Trust Lounge, a private environment for senior leaders to reconnect, debrief the day, and stress-test who they want to work with next. Conversations here center on advancing enterprise initiatives, aligning on regulatory strategy, and exploring concrete commercial or investment opportunities. 

Why Attend:

• The most valuable partnerships are formed here, off-the-record exchanges that lead to real deals, joint programs, and investments that shape the next wave of innovation and trust. 

Exclusive Executive Dinner Experience 

7:30 |  Invitation-Only Dinner (Off-Site) 

A private, invitation-only dinner convening senior executives for candid dialogue and strategic relationship-building in an intimate off-site setting. This is where the leaders shaping the future of AI in life sciences connect directly, without microphones, slides, or formality. 

Why Attend:

• This is where strategy becomes personal and partnerships become commitments. Share the table with leaders influencing regulation, defining governance models, and driving enterprise AI adoption, and leave with relationships strong enough to move initiatives, budgets, and transformation agendas forward.