August 26, 2024
6 min read
EMA/HMA Revised Guidance on Risk Minimization Measures
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Blog
October 30, 2025
6 min read
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.
Blog
October 23, 2025
6 min read
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.
Blog
October 20, 2025
9 min read
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 […]
Posts by Date
Blog
Blog
August 16, 2024
4 min read
The Importance of Patient Choice
Providing the patient with choice throughout their journey empowers them to take an active role in therapy initiation and persistence.
Blog
August 5, 2024
6 min read
Navigating Launch Readiness with FDA Negotiations
REMS readiness is a key component for certain drugs launch plans - are you on top of approval timelines and milestones and IT build needs?
Blog
July 29, 2024
5 min read
ICH/FDA Draft Guidance on RWD Safety Studies Highlight Their Increased Importance
Understand the latest international opinion on the plan, design, and analysis of pharmacoepidemiological safety studies using RWD.
Blog
July 22, 2024
9 min read
Enhance Your Pharmacovigilance and Regulatory Compliance with Expert PV System Transition Management and Seamless Migration
Whether your transition includes a vendor change, acquisition, or portfolio expansion, UBC makes it easy to transition your system.
Blog
June 24, 2024
4 min read
RWD Enrichment Studies: Linking Pre- and Post-Trial Data Utilizing Tokenization
Clinical trials provide a limited view of patient experience but this can be expanded through tokenization to link pre- and post-trial data.
Blog
June 7, 2024
5 min read
Pharmacovigilance Tableau Data Analytics Platform: All-in-One Dashboard System for PV Metrics and KPIs
The UBC PV Tableau Data Analytics Platform provides an all-in-one dashboard system for safety Key Performance Indicators (KPIs) analysis and compliance oversight.
Blog
May 30, 2024
1 min read
Data Liquidity for Clinical Trials: Patient Autonomy and the Rise of AI
UBC and Seqster talked with Chilmark Research about the power of patient-mediated electronic medical record release.
Blog
May 28, 2024
5 min read
Pharmacovigilance Case Automation Platform: Cost-Efficient Solution to Manage Increased Case Volume
UBC’s PV case automation platform is purpose-built with a focus on customizing our technology for your specific product and program needs.
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