Insights from
UBC's Expert Voices

UBC recently completed a multi-country feasibility assessment to identify disease registries capable of supporting a PASS for a novel therapy targeting a hereditary muscular disorder. The study evaluated registry data elements, quality, and governance to ensure fit-for-purpose real-world data (RWD) for generating reliable RWE.

Learn how companies are making the most of their oversight capabilities by leveraging real-time data to improve the health of their pharmacovigilance program.

AI is revolutionizing drug safety, but without proper guardrails, it can introduce new risks. Learn how risk-based integration strategies are helping life sciences companies harness AI’s power while maintaining trust, transparency, and compliance.

Platforms designed specifically for the collection and communication of operational pharmacovigilance data are breaking down long-standing barriers to real-time PV oversight.

Drug repurposing is transforming the landscape of rare disease treatment by leveraging existing medications for new uses. With significantly lower development costs and faster timelines, this approach is gaining traction—especially when supported by natural history studies that provide deep insights into disease progression and real-world treatment patterns.

The EMA’s August 2025 guidance on embryo-foetal risk minimisation marks a pivotal step in harmonizing safety protocols across the EU. This blog breaks down the new Addendum I to GVP Module XVI, clarifying what constitutes a Pregnancy Prevention Programme and how risk minimisation tools can be effectively implemented without compromising patient access to essential treatments.

Instability is woven into our industry’s DNA. We operate daily in a high-stakes, high-risk environment where financial pressures, regulatory changes, and patient lives hang in the balance. The CRO selection process reflects this tension, few other sectors require competitors to both challenge and collaborate with one another, often for the same client. Our ecosystem is […]

In this expert interview, UBC’s Tom Coles and Peter Psarologos dive into the essential role of the QPPV in EU pharmacovigilance. From legal requirements to strategic value across the product lifecycle, discover how UBC helps clients stay compliant, inspection-ready, and focused on patient safety.

Recently, Aaron Berger, SVP of Evidence Development Solutions, had a chance to sit down and talk with Joel White of Marketcap consultants, to discuss the state of life science trends and the next wave of real world evidence generation. Joel has long been an important voice in the life sciences space, always with his finger […]