Real-World Evidence in Health Technology Development

Real-World Evidence in Health Technology Development
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 recognised thought leader in the intersection of regulation, methodology, and operational practice in RWE.

The use of external control arms based on real-world data to support regulatory and HTA decisions: providing insights from case studies.

This session will explore the existing, and draft development guidelines for the use of external control arms based on real world data to support regulatory / HTA decision-making with the focus on the guidelines being developed by MHRA, EMA, and the FDA. This session will highlight where ECAs have been, or have potential to be used, as a key avenue for positive regulatory / HTA assessment outcomes of ATMP. Case studies will be utilised to initiate discussion on the challenges impeding the quality and consistency of RWE generation in the context of external controls.

Speakers:

Binu Gurung is a Senior Health Economics and Market Access Manager at CGT Catapult. She joined CGT Catapult in 2022 and has since worked in projects of potential innovative advanced therapies for oncology and non-oncology disease including rare diseases supporting collaborators with health economic assessments, payer/clinician engagement, and advising on clinical trial design. Prior to joining CGT Catapult, Binu gained extensive experience in consultancy and academic settings, where she led systematic reviews and developed health economic models to support submissions to health technology assessment (HTA) bodies both within the UK and internationally. She holds a master’s degree in health economics and health policy.


Tom Strakosch is a Senior Manager in the Cell and Gene Therapy (CGT) Catapult Health Economics and Market Access team. Tom has an undergraduate degree in economics, with a master’s degree in health economics. He has worked at Catapult for 18 months supporting the development of innovative cell and gene therapies. Prior to working at Catapult, he worked for 5 years at a health economics consultancy supporting technologies through health technology appraisals alongside post-launch activities.


PRICING
TOPRA Members: Free  
Non-member: £60
When
12/11/2025 14:00 - 17:00
Where
The Sir Arthur Conan Doyle Centre 25 Palmerston Place Edinburgh EH12 5AP UNITED KINGDOM
Sign in or create an account to register Registration ends 11/11/2025 16:00 (GMT Standard Time)
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