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 exploring how life sciences organizations across Europe are responding to increasing 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 first-hand experience as a researcher and later as a senior industry leader.
That background gives him a grounded, practical view of what is actually changing within pharmaceutical and biotech organizations, beyond the headlines around AI Acts, data rules and compliance frameworks.
We talk openly about why regulations like GDPR, the EU AI Act and ACT-EU are putting real pressure on organizations that already operate in highly controlled environments. But instead of seeing compliance as a blocker, Werner explains why this moment offers an opening for better collaboration, stronger data foundations, and more consistent ways of working across internal teams.
He says the real challenge lies less with the technology and more with how companies manage data quality, align processes and break down silos that slow down everything from pilot project development to regulatory response times.
Our conversation also addresses where AI is really making progress in the life sciences today and where caution still applies. Werner shares why drug discovery and non-patient use cases are accelerating, while areas like trial execution and real-world patient data still require stronger evidence, cleaner data sets, and clearer governance.
His perspective cuts through the hype and focuses on what is realistic in an industry where patient safety remains the defining responsibility.
We also explore patient recruitment, decentralized research, and the growing complexity of diseases themselves. Advances in genomics and diagnostics are changing the way studies are designed, which in turn raises questions about access to electronic health records, the harmonization of data across Europe and the safeguards that regulators consider most important.
Werner connects these dots in a way that highlights both the operational tension and the long-term upside. Towards the end, we look ahead to emerging technologies such as blockchain and connected devices, and how they can strengthen data integrity, monitoring, and regulatory trust over time. It is a thoughtful discussion that reflects both optimism and realism, and is rooted in lived experience rather than theory.
If you work anywhere near clinical research, regulation, or digital transformation in the life sciences, this episode provides a clear picture of where the industry is today and where it may be going. How should organizations turn regulations into momentum instead of resistance, and what does it take to gain lasting trust from patients, partners and regulators?
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