What can AI tools do for regulatory professionals? Let’s find out together.

The RAPS AI in Regulatory Conference will examine how artificial intelligence is transforming regulatory affairs across the medtech product lifecycle. 

Robert van Boxtel, a consultant at Medical Device Project who serves on the RAPS European Council (REC), the group that helped plan this event, joined us to talk about how this event came to be, what to expect, and more. 

What are the biggest issues Europe’s regulatory community faces in integrating AI into their regulatory work? 

Startups, scale-ups and SMEs currently have a broad selection in options that can help them move their quality management systems and technical documentation from document-based systems to data-based systems. 

But selecting the right fit for your organisation requires a significant amount of effort. Where do you find the time to assess all these options? And once you decide on a tool, managing the integration is the next big challenge.

Where AI meets regulatory reality 

The RAPS AI in Regulatory Conference is where we share actionable use cases, emerging trends, and strategic approaches to responsible AI adoption.

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What was the inspiration behind the RAPS AI in Regulatory Conference?  

The RAPS AI in Regulatory Conference intends to highlight the functionalities of AI solutions in specific processes and share the experiences real regulatory and quality professionals are having with these tools. 

We want to move from the technical subjects like risk management, clinical, and postmarket surveillance towards AI and software tooling used in these technical processes. This is driven by the needs expressed by our regulatory community over the last year. Several initiatives I’ve been part of, including as a member of the REC, have clarified that our community has a need for learning about the possibilities of AI integration throughout our workflows, and that includes generative AI and specific AI tools. 

This conference is dedicated to exploring the ways AI is transforming regulatory affairs across the medtech product lifecycle. What is one way AI has changed your role? 

I am a consultant at Medical Device Project. In our daily work, we encounter our customers struggling with a few common dilemmas: 

• Management, who says, "We should use AI. What is the cost reduction we can achieve?” 

• Regulatory experts, who ask, "Is our work now done by AI? Can I use AI to make workflows more efficient?” 

• IT, who says, "Where does our data go?" 

And many more stakeholders in these organisations are asking additional questions. 

These are questions people have asked for decades as different technologies have been introduced, but the scale and the speed are significantly greater with AI.

RAPS Conference Series events are designed to facilitate conversations. How would you explain the value of participating in these conferences to someone who is unfamiliar with them?  

I have been involved in the European RAPS Conference Series events since they started in 2023. These events were initiated and supported by the REC, as we saw the need for more technical, in-depth discussion with the real cases brought forward by industry and notified bodies. Our objective is to ensure that attendees leave with new knowledge on solutions based on real-world examples from our community. 

This particular conference has a different focus in 2026, but the event has been around for a few years. It started as the European Clinical and Risk Management Conference in 2023, then became the European Clinical, Risk, and Postmarket Surveillance Conference in 2024, and was the European Lifecycle Management Conference in 2025. And actually, the use of AI in all the different lifecycle management processes is on the agenda, linking this conference to previous years.

The value of this conference is that presenters will explain actual use cases for AI in regulatory affairs, with adequate time during and between sessions for discussion between speakers and attendees.

Attending will help you to better understand the possibilities when it comes to AI and will give you the tools you need when it comes time to decide on the optimal solution for your organisation. 

Can you spotlight a few sessions you’re especially excited about?

For the first time, we will be using a “World Café” approach, where the presentations on the use of AI in different workflows, such as risk management, clinical, and postmarket surveillance, will come together in a showcase session at the end of the first day. 

And of course, I am very excited for the final closing session, AI-Enabled Audit Readiness: Matching Technologies to Global Regulatory Challenges, which brings all the elements together and ensures attendees go home with the knowledge they were looking for. 

Finally, we have to ask: you've been involved in RAPS Conference Series events for a few years, and one thing that has stood out to me is the innovative plenary sessions you’ve put on, like this one:

Can you talk us through what was happening in that photo and how the audience responded to it?  

Instead of only presenting information or sharing thoughts through slides, I am a big fan of trying to find alternative ways to share knowledge during conferences. For example, through Therapy Sessions at RAPS Euro Convergence 2026 and during the closing session at last year’s European Lifecycle Management Conference, where Jennifer Neff and I were discussing the lifecycle of regulations and the love that we all have for our profession. 

And what better way than cycling, especially as that event was in the Netherlands, to share the ongoing evolution of regulations from our unique perspectives? We had great interactions, including a spontaneous love letter and a very personal story on stage. I challenge all conference organizers to find presenters who are creative in how they present their knowledge. This approach ensures that valuable content is brought forward and that everyone is having fun!