Preparing for ACT‑EU and regulatory alignment

What happens when decades of clinical research experience collide with a regulatory environment that is changing faster than ever?

In this episode of Tech Talks Daily, I sat down with Dr Werner Engelbrecht, Senior Director of Strategy at Veeva Systems, for a wide-ranging conversation that explores how life sciences organizations across Europe are responding to mounting regulatory pressure, rapid advances in AI, and growing expectations around transparency and patient trust.

Werner brings a rare perspective to this discussion. His career spans clinical research, pharmaceutical development, health authorities, and technology strategy, shaped by firsthand experience as an investigator and later as a senior industry leader.

That background gives him a grounded, practical view of what is actually changing inside pharma and biotech organizations, beyond the headlines around AI Acts, data rules, and compliance frameworks.

We talk openly about why regulations such as GDPR, the EU AI Act, and ACT-EU are creating real pressure for organizations that are already operating in highly controlled environments. But rather than framing compliance as a blocker, Werner explains why this moment presents an opening for better collaboration, stronger data foundations, and more consistent ways of working across internal teams.

According to him, the real challenge is less about technology and more about how companies manage data quality, align processes, and break down silos that slow everything from trial setup to regulatory response times.

Our conversation also digs into where AI is genuinely making progress today in life sciences and where caution still matters. Werner shares why drug discovery and non-patient-facing use cases are moving faster, while areas like trial execution and real-world patient data still demand stronger evidence, cleaner datasets, and clearer governance.

His perspective cuts through hype and focuses on what is realistic in an industry where patient safety remains the defining responsibility.

We also explore patient recruitment, decentralized trials, and the growing complexity of diseases themselves. Advances in genomics and diagnostics are reshaping how trials are designed, which in turn raises questions about access to electronic health records, data harmonization across Europe, and the safeguards regulators care about most.

Werner connects these dots in a way that highlights both the operational strain and the long-term upside. Toward the end, we look ahead at emerging technologies such as blockchain and connected devices, and how they could strengthen data integrity, monitoring, and regulatory confidence over time. It is a thoughtful discussion that reflects both optimism and realism, rooted in lived experience rather than theory.

If you are working anywhere near clinical research, regulatory affairs, or digital transformation in life sciences, this episode offers a clear-eyed view of where the industry stands today and where it may be heading next. How should organizations turn regulation into momentum instead of resistance, and what will it take to earn lasting trust from patients, partners, and regulators alike?

Useful Links

• Connect with Dr Werner Engelbrecht
• Learn more about Veeva Systems
• Viva Summit Europe and Viva Summit USA
• Follow on LinkedIn

Thanks to our sponsors, Alcor, for supporting the show.