What occurs when many years of medical analysis expertise collide with a regulatory surroundings that’s altering quicker than ever?
On this episode of Tech Talks Each day, I sat down with Dr Werner Engelbrecht, Senior Director of Technique at Veeva Techniques, for a wide-ranging dialog that explores how life sciences organizations throughout Europe are responding to mounting regulatory stress, speedy advances in AI, and rising expectations round transparency and affected person belief.
Werner brings a uncommon perspective to this dialogue. His profession spans medical analysis, pharmaceutical growth, well being authorities, and expertise technique, formed by firsthand expertise as an investigator and later as a senior trade chief.
That background provides him a grounded, sensible view of what’s really altering inside pharma and biotech organizations, past the headlines round AI Acts, information guidelines, and compliance frameworks.
We speak brazenly about why rules similar to GDPR, the EU AI Act, and ACT-EU are creating actual stress for organizations which can be already working in extremely managed environments. However quite than framing compliance as a blocker, Werner explains why this second presents a gap for higher collaboration, stronger information foundations, and extra constant methods of working throughout inner groups.
In keeping with him, the actual problem is much less about expertise and extra about how corporations handle information high quality, align processes, and break down silos that gradual the whole lot from trial setup to regulatory response instances.
Our dialog additionally digs into the place AI is genuinely making progress at this time in life sciences and the place warning nonetheless issues. Werner shares why drug discovery and non-patient-facing use instances are transferring quicker, whereas areas like trial execution and real-world affected person information nonetheless demand stronger proof, cleaner datasets, and clearer governance.
His perspective cuts by way of hype and focuses on what’s practical in an trade the place affected person security stays the defining duty.
We additionally discover affected person recruitment, decentralized trials, and the rising complexity of illnesses themselves. Advances in genomics and diagnostics are reshaping how trials are designed, which in flip raises questions on entry to digital well being data, information harmonization throughout Europe, and the safeguards regulators care about most.
Werner connects these dots in a method that highlights each the operational pressure and the long-term upside. Towards the top, we glance forward at rising applied sciences similar to blockchain and linked units, and the way they might strengthen information integrity, monitoring, and regulatory confidence over time. It’s a considerate dialogue that displays each optimism and realism, rooted in lived expertise quite than concept.
In case you are working wherever close to medical analysis, regulatory affairs, or digital transformation in life sciences, this episode affords a clear-eyed view of the place the trade stands at this time and the place it could be heading subsequent. How ought to organizations flip regulation into momentum as a substitute of resistance, and what’s going to it take to earn lasting belief from sufferers, companions, and regulators alike?
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