Seamus Kearney graduated from the Queens University of Belfast with an MSc in Engineering and immediately began his career in the medical devices industry, where he has spent the last 22 years in a variety of roles from development lead, project management, QA/RA and clinical operations. Seamus has worked with many of the global leaders in the in vitro diagnostics industry, including J&J, Roche Diagnostics and QIAGEN and founded ARC Regulatory in 2010 with the aim of supporting companies in the IVD sector through myriad global regulations for device development and clinical validation. Over the past 7 years, ARC has focused on the precision medicine sector, supporting pharma and their Dx partners in global compliance from vendor selection, due diligence, Dx regulations, GCP, study management and monitoring.
Clinical Dx Showcase:
ARC Regulatory is a niche provider of global regulatory and clinical research solutions to the precision medicine and IVD industry. Our mission is to support companies, from the world’s top pharmaceutical and biotech leaders to medical start-ups with the ambition to improve patient care.
How IVDR is Impacting Precision Medicine Trials
With IVDR Date of Application already taken place, ARC plans to deliver a talk surrounding current regulations.
Session Abstract – PMWC 2023 Silicon Valley
The PMWC 2023 Data Applications in Clinical Diagnostics Showcase will provide a 15-minute time slot for selected organizations, including commercial companies, clinical testing labs, and medical research institutions, to present their latest advancements, insights, applications, and technologies to an audience of clinicians, leading investigators, academic institutions, pharma and biotech, investors, and potential clients. We will learn about new technologies and findings that promise expedited, cost-effective, and accurate clinical diagnosis for early disease detection, treatment decisions, and disease prevention.
- Clinical Dx/Oncology (including Liquid Biopsy)
- Clinical Dx/Cardio Vascular
- Clinical Dx/Nerodegenerative