Author: Preeya Beczek, Managing Director and Co-Founder of Beczek.COM

Advanced automation, harnessing AI, offers to transform not only Global Regulatory Affairs but also Pharmacovigilance and other complementary activities. That’s as long as life sciences companies understand how to apply the technology to elicit real value, and how to enable wider process innovation within inevitable industry safeguards. In anticipation of a rousing Breakthrough 2025, Regulatory consultant and panel session moderator Preeya Beczek sets out her hopes for this year’s event.

When I attended Breakthrough 2024 in London last spring, it was as an observer, and I was struck by what a busy and electrifying event it was – with so many opportunities to swap notes and ideas with some of the greatest minds and biggest thinkers in our industry.

Having expressed my keenness to be more involved with the event in the future, I was delighted to be invited to participate in Breakthrough 2025 as a session moderator, and I look forward very much to being in Zurich this March and back among such stimulating company.

Change is the only constant now

I’ve been struck over the last 12 months by how rapidly this industry is evolving suddenly. Not only in terms of its groundbreaking scientific output, but also in its pursuit of real operational change.

This is evident in companies’ preparedness to truly innovate, using technology – as a means to radically transform efficiency and drive down costs, while upholding the highest standards of operational performance, regulatory adherence, and safety compliance.

For my designated panel session – Regulatory Operations: Driving Progress and Preparing for the Future – I’ll be joined by Bjoern Spudy, Director of GRA Operations at medtech company B. Braun; Michael Sonntag, Director of Global Regulatory Affairs and Pharmacovigilance at Wörwag Pharma; and Steve Gens of Gens & Associates.

I am excited about starting the conversation on how the regulatory landscape is setting itself up for AI and advanced automation, and what this could mean for the future.

Revising roles, reviewing skills

In 5-10 years’ time, the functions and roles we know today are likely to look very different. Advanced automation’s impact won’t be felt only in the unprecedented scope for efficiency gains, but also in the changes AI and advanced automation will prompt to the everyday work teams do. What will this mean in terms of a need for upskilling, and how well will teams be supported in that? These are all pertinent questions now.

The fact is that AI-powered automation is coming; indeed, it is already here – so Regulatory Affairs and Pharmacovigilance teams will have to embrace it. To do this impactfully, they will need a good level of appreciation of where the true value lies, and what the strongest use cases are.

To keep pace with accelerating technology developments, with peers and with market expectations, individual departments and teams cannot treat this as “trying a piece of the pie”. In the business of compliance and safety, whether those involved are responsible for running processes, or for changing infrastructure, they must now hone their focus on where advanced automation can most tangibly help – and how innovation might best be balanced with authorities’ expectations.

AI automation will cross departmental divides

One of the developments that most excites me is the expansion of AI across both Regulatory and Safety operations, enabling not just isolated step-changes in productivity, but also continuity in and multiplication of those benefits across extended processes and functional divides. ArisGlobal’s NavaX engine enables exactly that, which is a very promising development for this industry. Something we will all hear a great deal more about across the Breakthrough 2025 event, no doubt.

Last year I was blown away by the quality of speakers, and the impressive crowd the event attracted. It’s always invaluable to see people face to face, and to gain a truer sense of people’s latest preoccupations and passions. There is so much to discuss this year, I honestly can’t wait.

Preeya Beczek is Managing Director and Co-Founder of Beczek.COM Ltd, based in Surrey, UK. 

At Breakthrough 2025, at 10:50 the morning of Day 1 – Tuesday March 18 – she will moderate the panel debate, Regulatory Operations: Driving Progress and Preparing for the Future.