The Role of Real-World Evidence in Health Technology Develop

The Role of Real-World Evidence in Health Technology Develop
Registration is now open for TOPRA in Scotland's final meeting of 2025 to be held at the ACD Centre.  Join us, and our expert speakers, as we discuss the role of real-world (RWE) evidence in health technology development. RWE continues to gain prominence as a tool in health technology development with developers and regulators both looking to leverage the insights it can offer to support alternative pathways to market - whether it is through external control arms or post-launch evidence generation - there's a lot to be aware of.  Despite this, the regulatory considerations around RWE are often misunderstood.  Join us and our expert speakers as we look to remove some of these misunderstandings with our expert speakers.




Date: 12/11/2025
Time: 14:00 - 17:00

Fit for Purpose? The Regulatory Evolution of Real-World Evidence in Medicines Development

This session will explore how regulators across Europe and the globe are shaping expectations for RWE generated from non-interventional (drug) studies (NIS). It will highlight recent guidance updates, trends in regulatory decision-making and practical considerations for designing and conducting RWE studies that are "fit for purpose" in regulatory submissions.

Speaker: 
Stuart McCully is a regulatory and operational expert in real-world research (RWR), with over two decades of experience supporting the design and delivery of non-interventional studies (NIS) across the globe. He is the founder of Phoenix-RWR and co-founder of RWR-Regs, a regulatory intelligence platform dedicated to NIS compliance. Stuart contributed to the development of the DIA TMF reference model for NIS and is a recognized thought leader in the intersection of regulation, methodology, and operational practice in RWE.
When
12/11/2025 14:00 - 17:00
Where
The Sir Arthur Conan Doyle Centre 25 Palmerston Place Edinburgh EH12 5AP UNITED KINGDOM
Registration begins 30/05/2025 14:00 (GMT Daylight Time)
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