IVD Study Steps for Success: Safety and Quality of Global IVD Clinical Performance Studies

In the field of precision medicine, in vitro diagnostic devices (IVDs), such as companion diagnostics (CDx) and clinical trial assays (CTA), are vital for biomarker-driven subject eligibility, enabling targeted treatment of malignancies and chronic diseases.

Global IVD clinical performance studies facilitate the use of CDx and CTAs in precision medicine to be accurate and reliable, as they enable data collection from diverse patient populations simultaneously.

However, the regulatory and ethical requirements for global IVD clinical performance studies are constantly changing, with each country requiring different criteria to be met.

Therefore, the quality management system, which supports the IVD clinical performance study, may need to comply with multiple standards including the International Council for Harmonization – Good Clinical Practice (ICH GCP), Good Clinical Laboratory Practice (GCLP), In Vitro Diagnostic Regulation (IVDR), Investigational Device Exemption (IDE), International Organization for Standardization (ISO) 20916 and Human Genetic Resources Administration of China (HGRAC).

Furthermore, because regulatory authorities may evaluate the IVD clinical performance study data only at the time of marketing submission, it is important to maintain strong quality systems and conduct regular audits to ensure successful marketing approvals and protect the interests of the pharmaceutical or diagnostic sponsor.

This webinar explores the ‘Steps for Success’ in implementing global IVD clinical performance studies. The featured speakers will discuss common findings raised by international regulators in IVD clinical performance studies, and the steps needed to ensure the quality, safety and success of these studies.

What You Will Learn

Listeners will gain insight about:

• Global IVD clinical performance study monitoring
• Common findings raised by global regulators and the impact on IVD clinical performance studies and clinical trials
• The importance of alignment with quality and safety requirements in global IVD clinical performance studies, and how this can be operationalized in practice
• Practical strategies for supporting global IVD clinical performance studies

Who Should listen?

This webinar will appeal to pharma and diagnostic device companies involved in global IVD clinical performance studies (CDx and CTA), including those looking to expand in China and Europe. This webinar will benefit decision makers with responsibilities including, but not limited to:

• Clinical trials which include investigational diagnostic devices
• Clinical trial assays (CTA)
• Companion diagnostics (CDx)
• Clinical trial monitoring
• Regulatory Affairs

Presenters:

Dr. Caoifa Dougan, Global Clinical Trial Monitoring Team Leader, Almac Diagnostic Services

Caoifa Dougan attained her BSc in Biomedical Science from Queen’s University Belfast, followed by her PhD based on the role of protease inhibitors in oncology and respiratory diseases at The Wellcome-Wolfson Institute of Experimental Medicine. She then completed her postgraduate work at the Patrick G. Johnston Center for Cancer Research.
Caoifa leads the Global Clinical Trial Monitoring team at Almac Diagnostic Services. The team is responsible for monitoring the progress of IVD studies, safeguarding patient safety and rights, ensuring that the conduct of IVD studies complies with applicable regulatory requirements, protocols and documented procedures and verifying the integrity of IVD study data. Before joining Almac Diagnostic Services in 2023, Caoifa worked at an Australasian Medical Education College and as a Study Director within a GLP and GMP-compliant pharmaceutical company.

Dr. Charlene Robb, Global IVD Regulatory Affairs Manager, Almac Diagnostic Services 

 Charlene studied at Queen’s University Belfast, where she attained her Master’s degree in Pharmacy and a PhD in Molecular Therapeutics. She then continued at the university working as a Post-Doctoral Research Fellow, developing novel in vitro diagnostic devices (IVDs) for the detection of active proteases. These IVDs became the basis of a spin-out company, ProAxsis, where she worked as a Regulatory Affairs Scientist, developing the company’s Quality Management System and ensuring regulatory compliance. Charlene has also worked as a Lecturer in Regulatory Affairs for China Medical University. Charlene joined Almac Diagnostic Services’ regulatory team in 2019 and has since been responsible for developing and implementing regulatory strategies for clinical trial assays and companion diagnostics within global clinical trials.