Registry feasibility assessments for post-authorization safety studies (PASS): Learnings and Challenges
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.
Making the most of real-time pharmacovigilance oversight: Applying operational data analytics across diverse use cases
Learn how companies are making the most of their oversight capabilities by leveraging real-time data to improve the health of their pharmacovigilance program.
Putting a Seatbelt on AI: How Risk-Based Integration is Transforming Drug Safety
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.
Operational Data On Demand: Overcoming Barriers to Effective Pharmacovigilance Oversight
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 in Rare Diseases: The Impact of Natural History Studies
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.
EMA Issues Guidance on Risk Minimisation Measures for Medicinal Products with Embryo-Foetal Risks
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.
To Rescue or Not to Rescue Your Study: How to Spot Trigger Points in Strategic Partnerships
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 […]
The Critical Role of the QPPV: Insights from UBC’s Pharmacovigilance Experts
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.
Evidence Matters: Joel White of Marketcap Consultants
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 […]
