Clinical trial sponsors expanding studies across Europe often face complex regulatory pathways for sample testing, particularly when assays must support EU and UK patient cohorts within compliant timelines. This webinar explores how Health Institution designation under the IVDR Health Institution Exception, Article 5(5), can support a more efficient approach to testing EU and UK clinical trial samples.
Following alignment with the MHRA in 2025, a Northern Ireland–based Health Institution model can remove the requirement for a Performance Study Application and Competent Authority approval for certain in-house devices. This creates an opportunity to accelerate study start-up timelines, reduce administrative burden and lower overall costs while maintaining regulatory compliance.
This webinar will examine how health institution status can benefit clinical trial sponsors through in-house assay development, assay protocol transfers and flexible test adaptation. Attendees will gain insight into how these approaches can support precision medicine strategies, particularly for EU patient cohorts, while enabling internal development and validation of diagnostic solutions tailored to specific study needs.
The session will also outline the quality and regulatory framework required to support this model, including a Quality Management System aligned with ISO 13485 and ISO 14971, alongside compliance with ISO 15189, CAP and CLIA standards. The webinar will discuss how assay verification and validation activities can align with IVDR General Safety and Performance Requirements and how sample testing can be conducted in accordance with IVD medical device Good Clinical Practice to support data integrity and patient safety.
Register for this webinar to learn how sample testing can be streamlined across EU and UK clinical trials while maintaining quality, compliance and operational efficiency.
Speakers
Dr. Lindsey Bennie, Laboratory Manager, ARC Regulatory
Dr Lindsey Bennie is the Laboratory Manager at ARC Regulatory, where she leads the development and operation of a GCP-compliant laboratory supporting global diagnostic and clinical programmes. She began her career at pHion Therapeutics, a Queen’s University Belfast spin-out, progressing from R&D Scientist to Principal Scientist over five years. Lindsey later transitioned into clinical project management at ARC, specialising in IVDR and the establishment of a clinical central laboratory. Her role evolved as she worked closely with ARC’s leadership to build and scale laboratory capabilities, culminating in her appointment as Laboratory Manager.
She holds an MSci in Pharmacology from the University of Strathclyde and a PhD from Queen’s University Belfast, where her research focused on improving radiotherapy response in prostate cancer. Lindsey brings a strong combination of scientific expertise, regulatory insight and operational leadership, and has contributed to industry conferences and events on topics including laboratory strategy and diagnostic development, supporting the advancement of precision medicine and improved patient outcomes.
Message Presenter
James Lappin, MB, BCh, BAO, Associate Director, Global Regulatory Compliance, Translational Biomarkers
After graduating from Queens University Belfast with a Degree in Medicine (MB BCh BaO), James worked in the NHS for five years before moving into the medical device industry in 2014 and gaining extensive experience in IVD/CDx clinical study management. Through his work at ARC, he has supported Top 10 Pharma and MedTech organisations with their Precision Medicine pipelines as a subject matter expert in Quality Management (ISO 13485), global IVD/CDx regulations (including IVDR and 21 CFR 812) and IVD Good Study Practice (ISO 20916). As the Associate Director – Global Regulatory Compliance, James is responsible for leading ARC’s clinical, quality and regulatory consulting service, ensuring that clients’ Precision Medicine clinical trials are conducted to the highest standard.
Message PresenterWho Should Attend?
This webinar will appeal to:
- Clinical Trial Sponsors and biotech/pharma companies expanding into EU Markets
- Clinical Operations and Project Management professionals
- Regulatory Affairs and Quality Assurance Specialists
- Translational Medicine and Precision Medicine teams
- Laboratory and Diagnostic Development Leads
- CRO Partners seeking efficient EU & UK sample testing solutions
What You Will Learn
Attendees will learn:
- How Health Institution designation under IVDR Article 5(5) enables streamlined testing of EU and UK clinical trial samples
- Ways to accelerate clinical trial timelines and reduce costs by leveraging in-house assay development and eliminating certain regulatory approvals
- How flexible, compliant testing strategies can support precision medicine programmes across European patient cohorts
- The quality, regulatory framework and validated technologies needed to support reliable clinical trial data
Xtalks Partner
ARC Regulatory
Based in Northern Ireland, ARC is a Clinical Research Organisation focused on delivering compliance excellence within the precision medicine sector. The company supports leading pharmaceutical R&D organisations by enabling the use of unapproved diagnostics in clinical development programmes for patient selection and stratification. Acting as a strategic partner, ARC assumes full sponsor responsibility for IVD studies conducted alongside IND/IMP trials.
ARC’s purpose is to accelerate global patient access to precision medicine clinical trials. This is achieved through a highly experienced team with deep domain expertise and strong partnerships with leading international clients. Its multidisciplinary team spans regulatory compliance, study design, approvals, quality assurance, and vendor management, alongside clinical research specialists who ensure studies meet global and local GCP standards and produce reliable biomarker data.
To further enhance its offering, ARC’s clinical trial enablement platform, ARC360 streamlines regulatory intelligence and accelerates the setup of complex clinical trials involving in vitro diagnostics.
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