Transforming regulatory intelligence into action

Introduction

At the recent Regulatory Intelligence Forum, industry leaders discussed how regulatory teams can transform regulatory surveillance into valuable outcomes. While many teams excel at monitoring and analyzing updates, they often struggle to convert this information into valuable business outcomes and actions. This forum focused on moving from monitoring to activating intelligence with structure, speed, and accountability.

Meet the experts

• Host: Chris Whalley, Senior Director and Head of Global Regulatory Intelligence and Analysis at Pfizer
• Speaker: Rüdiger Faust, Global Policy & Intelligence Lead at UCB

Chris and Rüdiger shared practical frameworks that help organizations connect regulatory intelligence to business impact.

What is regulatory action?

“Action is the defining characteristic of effective regulatory intelligence programs. Without it, intelligence remains theoretical and disconnected from the organization’s goals.” Chris Whalley – Chapter 1 – A general framework for regulatory intelligence in medical product research and development, RAPS reg intel 101 Book draft 4th edition.

What we’ve seen from talking with a number of reg intel teams is that sometimes there is more emphasis placed on the data and the analytics part of regulatory intelligence but they and their stakeholders are not always connecting that to the actions that the business can take based on that data. For many organizations that don’t have a reg intel team there can sometimes be views of intelligence as just paralysis by analysis. So, we need to work actively to overcome those types of misunderstandings about reg intel and really emphasize the actions that we’re all taking based on that intelligence, so help everyone to see the value that comes from reg intel.

Regulatory Intelligence Framework

Chris presented a framework that unifies various teams under a common understanding of regulatory intelligence. It comprises four key capabilities:

1. Observe: Monitor for any potential updates or changes.
2. Communicate: Notify stakeholders.
3. Evaluate: Assess the impact of new intelligence.
4. Act: Implement changes based on evaluations.

Each capability involves people, processes, and technology, forming a comprehensive model for regulatory intelligence.

Impact assessment: an example of turning intelligence into action

An example of effective regulatory intelligence in action involves conducting an impact assessment:

1. Monitoring: Observe incoming communications about regulatory updates.
2. Triaging: Prioritize information and communicate to the SMEs and owners who may be impacted.
3. Evaluation: Assess impacts on quality and compliance, for example on manufacturing or labelling.
4. Action: Implement necessary changes and assign tasks and manage those through to outcomes.

Common challenges taking regulatory intelligence to action

Regulatory teams face several challenges in taking regulatory intelligence through into action:

• Diverse methodologies, from organized systems to Excel spreadsheets.
• Difficulty assessing the impact of new guidance on growing product portfolios.
• Increasing complexity and volume of incoming data.
• The need for cross-functional coordination and ownership.
• Medium to large enterprise organizations are always changing with leavers and new starters.

The growing complexity of regulatory intelligence

One of the greatest challenges of all is the increasing need to monitor new emerging sources and sources which frequently change or have questionable levels of reliability, such as social media, which presents both opportunities and challenges. The diversity of sources complicates the regulatory landscape, making it essential to distinguish valuable information from noise.

Collaboration: key to intelligence activation

Collaboration is vital for turning intelligence into valuable business outcomes. Establishing internal channels for communication allows teams to share insights and monitor new sources collectively. Partnering with GxP Quality Compliance teams and integrating regulatory intelligence with business strategy and commercial teams enhances the ability for regulatory intelligence to support business-wide decision-making.

Different approaches to keeping stakeholder lists current

New starters and leavers in a medium to large enterprise mean your audience is constantly shifting its membership.

1. Manually monitor: Designate a person or a group to track organizational changes. If this is done using Excel this is not recommended as your list will always lag behind real-time and this admin task becomes too onerous and demands too much resource.
2. Self-subscription: Empower employees to subscribe to relevant topics and channels to keep updated on what’s important to them.
3. Maintain the most critical contacts: Keep a list of essential stakeholders who must be informed.

Ensuring actions are followed through to outcomes

To ensure important updates and changes are assessed and acted upon:

• Define clear processes and train teams.
• Establish RACI (Responsible, Accountable, Consulted, Informed) roles across different teams.
• Implement automated reporting for transparency.
• Create feedback loops to communicate outcomes.

Tools for managing regulatory intelligence

Many organizations are on a digital transformation journey to enhance efficiency and productivity which means most are using a mixture of different systems and tools, and these vary depending on the digital maturity and skills of that organization. Teams are using a range of tools from Excel, Sharepoint, AI and SaaS AI-enhanced platforms (like Infodesk).

The role of AI in regulatory intelligence

Of all the available tools, AI is the one which keeps coming up in conversations, as we all learn about the pros and cons of this new capability. AI is increasingly used in regulatory work, doubling the capacity for handling ad-hoc requests. However, human interpretation remains crucial. AI tools can assist in search strategies but must be tailored to regulatory language and needs. In summary:

• The number of ad-hoc requests regulatory teams are able to handle have almost doubled in the past year because of using AI.
• You must not just take an AI answer and forward it on, instead use AI Search to find the essential needles in the haystacks.
• AI platforms such as Copilot and Claud aren’t there yet as they don’t know regulatory language and are not yet trained on specialist regulatory needs and expertise, so we need trained models to our language, needs and business. As a result some internal teams are building regulatory aware LLMs but the downside is training them is a lot of work and is absorbing a lot of resource.
• The interpretation of AI answers still must be done by humans.
• Getting permission to connect an AI tool to an internal data set is problematic so the practical implementation is very challenging today.
• Depending on how mature your business is you will have a wide set of diverse data. A key part of digital transformation is to provide a good data foundation. This will over time enable AI tools to be better quality.
• There is a lot of mistrust in the quality of what AI tools produce especially as lot of the data and results can’t be confidently be traced back to source, and without that the intelligence doesn’t support compliance, so becomes redundant. There is a strategic compliance necessity to establish precedent, to inform the new strategy, so if you’re using AI you must evaluate the accuracy. If you don’t trust the source and know the source you’re back to manual surveillance.
• Chris said he liked the Infodesk AI Search feature because it’s only looking at the approved content in the platform, so you’re confident on the source, it’s not open to the whole Internet, so with the protection of the walled garden of Infodesk you’re confident on the content and quality and not wasting time and resources trying to gauge how much you trust what you’re seeing.
• The human interaction is critical as is human decision-making.

The future of regulatory intelligence workflows

In the coming years, workflows will evolve to include pre-triaged data and metadata, enhancing efficiency. As technology advances, regulatory professionals will need to adapt their skills and communication strategies.

RAPS Regulatory Intelligence Conference

Join us at the RAPS Regulatory Intelligence Conference on March 3-4, 2026, where Infodesk will showcase innovative regulatory intelligence and regulatory workflow solutions.