Off-label? Don't panic: A strategic approach to real-world data
Thursday 4 June, 2026
10:00 EDT | 15:00 BST | 16:00 CEST
Real-world data (RWD) and real-world evidence (RWE) are rapidly reshaping clinical and regulatory strategies under EU MDR and beyond. Yet despite growing recognition of their value, many manufacturers still struggle to collect, structure, and leverage RWD effectively; whether that means selecting the right collection approach, meeting notified body expectations, or knowing how to act on unexpected findings such as off-label use.
When approached strategically, RWD can help confirm long-term safety and performance, strengthen your clinical evidence base, support label expansions, and identify unmet clinical needs. The challenge lies in building a framework that is both methodologically robust and proportionate to your device and regulatory context.
Purdie Pascoe is delighted to host this 60-minute live webinar, featuring expert presenters Edward Nobrega, Principal Clinical Evaluation Scientist at Boston Scientific, Breda Kearney, Clinical Regulatory Lead at BSI, and Marcus Torr, Head of Post Market Surveys at Purdie Pascoe.
Key takeaways:
RWD and RWE in practice: Understand the role of real-world data in PMCF and global frameworks, its importance to clinical evidence strategies, and how to choose the right collection approach, such as surveys, based on device characteristics and evidence gaps.
Notified Body expectations: Learn how regulators assess post-market RWD, and what "good" data looks like for regulatory decision-making
Strategic evidence planning: Discover how to build a scalable, portfolio-wide approach to clinical evidence generation
From risk to opportunity: Explore how off-label use, when properly managed, can support evidence generation and potential label expansion
Live Q&A: Submit your questions upon registering and during the live event