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Life Sciences Regulatory Affairs

Navigating today’s healthcare regulatory environment requires understanding what’s coming next. As regulatory frameworks evolve, AI tools mature, and global expectations tighten, Regulatory Intelligence has become a critical function for organizations aiming to remain compliant, competitive, and most important -> future-ready.

This year, RAPS and TOPRA jointly hosted the Regulatory Intelligence Conference Europe 2025, bringing together industry leaders for a deep, targeted exploration of the most urgent RI themes. The event delivered actionable insights, strategic discussions, and meaningful connections.

If you’re responsible for enabling smarter decisions, reducing compliance risks, and strengthening regulatory planning across your organization, this conference was designed for you. We have compiled all our key takeaways in this article.

What Shaped the Conversation This Year

Across sessions and one-on-one discussions, a few themes consistently stood out.

1. The Expanding Identity of Regulatory Intelligence

RI continues to transition from a support function to a strategic necessity. Discussions highlighted how RI is being woven into portfolio planning, risk assessment, market strategy, and cross-functional decision-making. Organizations are recognizing that proactive intelligence is no longer optional.

2. Building RI Functions That Actually Work

Several speakers shared experiences from building or maturing their RI teams. The message was clear: there is no universal model, but the most successful teams share common traits -> well-defined processes, cross-functional alignment, and the ability to translate data into impact.

3. Showing the Value of RI (With Metrics That Matter)

Leaders emphasized the need for measurable outcomes. From compliance readiness to submission acceleration, RI teams are increasingly expected to demonstrate strategic value through KPIs and evidence-driven reporting.

4. Collaboration Is the Real Differentiator

One of the strongest threads throughout the conference was the role of collaboration, not just within regulatory teams, but across Quality, PV, Compliance, Competitive Intelligence, and leadership. The organizations succeeding with RI are the ones ensuring insights don’t stay siloed.

5. Regulatory Agencies Are Becoming More Future-Facing

It was fascinating to hear agency perspectives on horizon scanning and how they identify emerging regulatory trends. Their approach echoed what the industry is experiencing – an increasing reliance on data, networks, and predictive insight.

6. The Evolving Role of the RI Professional

The profile of an RI specialist is changing. Skills like AI adoption, impact assessment, structured analysis, and automation management are becoming essential. Attendees from pharma, veterinary, devices, and niche sectors all echoed the same sentiment — RI roles are more strategic than ever.

What We Heard on the Ground

Conversations at the conference were shaped heavily by:

  • AI-driven RI and how organizations should realistically implement it
  • The growing importance of end-to-end automation (the talk of every booth!)
  • Impact assessment becoming a core expectation, not a bonus

The conference had a strong focus on the UK and Europe regulatory landscape and saw representation from diverse company types – from large enterprises to specialized SMEs.

Our Keynote: Navigating the AI Hype Cycle

We also had the opportunity to deliver a keynote session on:
“Navigating the AI Hype Cycle: Past, Present, and Future of RI Solutions”.

This session explored how AI in Regulatory Intelligence has evolved, separating genuine capability from short-term hype and what the next generation of RI tools will look like.

Click here to read in detail about this: [Link to the full article]

Spotlight on freya.intelligence

Alongside our keynote, we showcased the latest capabilities of our AI-powered regulatory intelligence platform – freya.intelligence. What stood out this year was not just the volume of interest at our booth, but the quality of conversations we had.

Many attendees approached us with a clear purpose:
they wanted to understand how we’re approaching Regulatory Intelligence differently, and what it means for teams working across Regulatory Operations, Quality, PV, and Compliance. Several visitors already knew about Freyr and quite a few recognized freya, our mascot, from LinkedIn. A small but proud moment for us, and a reminder of how engaged the Regulatory community has become with our work.

But what truly resonated with people was something deeper than AI features.

While multiple vendors showcased AI-driven capabilities (a theme very present across the conference), attendees consistently told us that what set freya.intelligence apart was our verified regulatory database – the foundation that powers everything we do. In a space where accuracy and traceability matter as much as innovation, our approach to building and maintaining a verified, credible repository struck a chord.

People appreciated that:

  • our AI is only as good as the regulatory data behind it
  • our insights are backed by validated, globally sourced regulations, not unverified web-scraping
  • and our platform is evolving with both automation and human expertise at its core

The feedback was encouraging but also grounding.

Freya.Intelligence continues to mature into a platform that blends deep regulatory expertise with AI-powered scalability, and this conference reaffirmed that we’re moving in the right direction. The industry is curious. They’re asking sharper questions. And they’re looking for solutions built on credibility, not hype.

CTA: Explore freya.intelligence free for 14-days (link: https://hubs.la/Q03Lg41C0)

Closing Thoughts

The Regulatory Intelligence Conference Europe 2025 reinforced something we have long believed: Regulatory Intelligence is at the heart of modern regulatory strategy.

This year’s discussions confirmed that organizations everywhere – across pharma, devices, veterinary, and emerging sectors are rethinking how they gather, interpret, and act on regulatory information. With AI, automation, and strategic collaboration reshaping the discipline, RI is poised to become even more essential.

We were delighted to participate, connect with peers, and contribute to these conversations. As always, we look forward to continuing to support regulatory teams worldwide as they navigate an increasingly dynamic landscape.

If you attended the conference, we’d love to hear your takeaways as well.
If not, we hope this recap gives you a clear sense of where the field is headed and why now is the time to elevate your Regulatory Intelligence strategy.

FAQs

The Regulatory Intelligence Conference Europe 2025 highlighted the growing strategic role of Regulatory Intelligence, increased adoption of AI-driven RI tools, stronger focus on impact assessment, and the importance of cross-functional collaboration to improve regulatory compliance and decision-making.

Regulatory Intelligence is critical for regulatory leaders because evolving regulations across the world, increasing global complexity, and tighter compliance expectations require proactive horizon scanning, data-driven insights, and early risk identification to stay audit-ready and future-ready.

AI is transforming Regulatory Intelligence by automating regulatory monitoring, accelerating impact assessments, enabling predictive insights, and reducing manual effort. However, conference discussions emphasized that AI effectiveness depends on verified, high-quality regulatory data and human oversight.

Modern RI professionals need skills in regulatory impact assessment, AI and automation adoption, data analysis, strategic communication, and cross-functional collaboration. The role has evolved from information gathering to influencing regulatory strategy and business decisions.

Organizations can demonstrate RI value by defining clear KPIs such as compliance readiness, submission efficiency, risk reduction, and regulatory decision support. Metrics-driven reporting helps show how Regulatory Intelligence contributes to regulatory strategy, compliance management, and business outcomes.

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