Why ‘AI first’ isn’t the answer for compliance.

Every regulatory intelligence and quality assurance team is now hearing the same question from the business. Can’t we just use AI, or ChatGPT, or build our own agent, and let it handle the workload? For regulatory intelligence and quality assurance work, the honest answer is more useful than a straight yes or no.

Our latest Regulatory Forum shares the lived experience of regulatory intelligence and quality assurance leaders who have already worked through where AI helps, where it doesn’t, and what ‘AI first’ gets wrong for regulatory intelligence and quality assurance work. Our next session brings together industry leaders from life sciences organizations to help you move faster along that same learning curve.

Male and female corporate professionals talking in an office

Why this session matters

Right now, regulatory and quality teams everywhere are working out where AI fits, often under pressure to adopt it before anyone has properly weighed the risks. This session is a chance to learn from leaders who have already worked through those decisions inside large, highly regulated organizations, what they trusted AI with, what they held back, and why. You’ll come away able to move faster along the same curve, and to avoid the false starts others have already hit.

Older female professional smiling while working in an office

What the forum will explore

Why ‘just use AI’ isn’t a serious answer for regulatory intelligence and quality assurance work
Where AI genuinely helps, from monitoring to summarizing and triage
Why interpretation and judgment can’t be delegated to an AI model
The build-versus-buy question, and the risk of an in-house project that never delivers
Keeping company data under company control
What the FDA’s Elsa tool signals about AI in regulated work
The observe, interpret, activate framework that makes AI safe to use
How a human-first, AI-empowered approach works in practice

Forum hosts

Chris Whalley

Sr. Director and Head of Global Regulatory Intelligence & Analysis

Chris leads regulatory intelligence activities across Pfizer. A new medicine veteran with 25 years’ experience building regulatory affairs and intelligence solutions that accelerate the delivery of novel drugs and devices to patients. Chris leads the team who deliver actionable insights for regulatory strategists, advancing product development and lifecycle with reduced time to market. Chris is the current Chair of RAPS Regulatory Convergence Planning Committee and the Recipient of RAPS Community Leadership Award 2023.

Christel Desadeleer

Compliance Integration Lead at UCB

Christel is responsible for turning regulatory complexity into strategic clarity at UCB. A leader in quality & compliance with nearly 20 years of experience in the healthcare industry across global, EMEA, and local levels, spanning multiple functions (enterprise, R&D, commercial, supply chain). Christel has witnessed firsthand how the evolving landscape of regulations and compliance requirements presents significant challenges. Today, the complexity of compliance is at a tipping point, and traditional approaches are no longer efficient, so Christel focuses on transforming regulatory complexity into clear, actionable strategies that not only ensure compliance but also support business growth and sustainability.

Who its for

The forum is for professionals across regulatory and quality compliance in life sciences, including:

Quality assurance and GxP teams and professionals
Regulatory intelligence and regulatory affairs teams
Anyone responsible for assessing regulatory impact and coordinating downstream action
Teams evaluating AI tools, generic LLMs, in-house builds, or purpose-built platforms, for regulatory compliance work

Smiling female professional in an office

What you’ll take away

You’ll get a clear, practical view of where AI belongs in regulatory compliance and quality assurance work, and where it doesn’t, including:

A grounded answer to the ‘can’t we just use AI’ question
Where AI genuinely helps today, and where human judgment can’t be delegated
What to weigh in a build-versus-buy decision
The questions to ask before letting AI near regulated data
How the observe, interpret, activate framework keeps humans in control
Practical first AI use cases that build trust

After the session, you’ll be invited to complete a short capability self-assessment. It covers people and skills, processes, governance, and technology, including AI. Spend five minutes or so answering ten short questions and we’ll generate a free tailored report with a summary of findings and recommended next steps.