ARC Regulatory

🔍 Help Us to Help You! - At ARC Regulatory we’re conducting important research to better understand the needs of laboratories involved in clinical research, particularly in IVD validation and testing. Your insights can make a difference! By participating in our short survey, you’re helping us to identify the key challenges and opportunities in the lab industry. And, as a thank you to all survey participants, you will receive an overview of our findings. 👉 Share Your Thoughts: https://bit.ly/3Xpi5KF Let’s work together to improve lab research! #ARCRegulatory #IVDValidation #LabNeeds #ClinicalResearch #CustomerFeedback #HelpUsHelpYou

Employee Spotlight: James Lappin, Associate Director, Global Regulatory Compliance, Translational Biomarkers This Friday, we are excited to spotlight our Head of Clinical Compliance & Quality Assurance, James Lappin. James graduated from Queens with a Degree in Medicine and worked as a Doctor in the NHS for five years, gaining experience across various specialties in Northern Ireland. He then transitioned to an advisory role at a private health clinic, where he excelled in quality management, leadership, client safety, results reporting, and training. As the Head of Clinical Compliance & Quality Assurance at ARC Regulatory, James plays a crucial role in supporting our clinical consulting services. He ensures that our clients' medical device research is conducted and reported in compliance with global Good Clinical Practice (GCP) standards. Additionally, he assists in the development of medical device technical documentation. James’s extensive experience and dedication to quality assurance and compliance make him an invaluable member of our team. You can view James and his team on our website here: https://bit.ly/4bAkgA8 #EmployeeSpotlight #ClinicalCompliance #QualityAssurance #ARCRegulatory #MedicalDevices #GCPCompliance"

Employee Spotlight: Seamus Kearney, Founder and CEO of ARC Regulatory Today, we spotlight Seamus Kearney, the visionary founder and CEO of ARC Regulatory. Seamus has 24 years of experience in the MedTech sector, with roles in both general and in vitro diagnostic medical device R&D. He graduated from Queen’s University Belfast with a degree in Aeronautical Engineering and an MSc in Advanced Computer Aided Engineering Design. His career includes significant contributions to J&J, Roche Diagnostics, Integra Life Sciences, and QIAGEN. In 2015, Seamus founded ARC Regulatory, a leading regulatory and clinical research organization supporting the IVD and precision medicine sectors. Under his leadership, ARC has grown to a team of 30 and supported over 50 global biomarker-driven drug programs. He also launched ARC360®, an innovative regulatory navigator for IVD in pharmaceutical trials. ARC’s mission is to be the preferred partner for the global precision medicine and IVD industry, advancing patient outcomes through top-quality clinical research. Learn more about Seamus and ARC Regulatory: https://bit.ly/3Lip7v0 #EmployeeSpotlight #ARCRegulatory #MedTech #IVD #ClinicalResearch #RegulatoryCompliance #ARC360"

💡 Attendee Insight 💡 Seamus Kearney, CEO & Founder of ARC Regulatory, has taken a proactive step by purchasing tickets for the Menopause NI Conference for his team. Understanding and supporting colleagues through every stage of life is vital for a thriving workplace. 💪🏻 We encourage other employers to do the same and demonstrate your commitment to being a supportive and inclusive employer. 🎟️https://lnkd.in/e7-YpgDY.. #MenopauseNI #SupportYourTeam #InclusiveWorkplace #ARCRegulatory Siobhan Kearney Belinda O'Neill Michelle McGinley Marie-louise Connolly Dr Andrea Latimer Geraldine McAleenan Adèle Davidson Jane McClenaghan

What a great and productive time our team members, Martin Krainz, Darren Ross and our CEO Seamus Kearney are having at the 14th World Clinical Biomarkers & Companion Diagnostics Summit in Boston ! If you are there, it is not too late to schedule a meeting and catch up with them over a coffee or a drink to discuss the latest industry trends https://bit.ly/4cWmKtk

Clinical Trial Sponsors - Are you ready for Article 5(5) of the IVDR? Compliance is not just a regulatory requirement—it is crucial for the success of your trials and the safety of patients. If you have not started preparing, ARC’s latest blog "The Impact of Article 5(5) on Clinical Trials and Compliance Tips for Sponsors" explains why now is the time and gives some top tips on how to achieve compliance. Read ARC’s latest blog - https://bit.ly/3ZsNGOn Stay up to date with the ever-changing regulatory landscape by signing up to our mailing list here: https://bit.ly/4gal9CL #ClinicalTrials #IVDR #Compliance #Healthcare #Article5(5) #RegulatoryCompliance #MedicalDevices #ARCRegulatory #Regulations #IVD

We're #hiring a new Senior Specialist – Regulatory Affairs (IVD and CDx) in Belfast Metropolitan Area. Apply today or share this post with your network.

ARC Regulatory is excited to announce that it is visiting the ESMO - European Society for Medical Oncology - Congress in Barcelona this September. Our team members David Lane, David Ribeiro and Heather Taylor will be attending the event on Monday the 16th. If you’re planning to be there they are looking forward to meeting with you. Why not schedule a meeting with them to catch up over a coffee? https://bit.ly/3XqdZ66

In May 2022, the transition period of the previous Directive 98/79/EC on in vitro diagnostic medical devices (IVDD) ended. This closed the last back door for a possible simplified market approval for IVDs. Since then, the full scope of EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) has been applied. Many manufacturers of IVD products suddenly find themselves faced with significantly higher and more complex requirements under the IVDR than before. At ARC, we are here to help. Join our SME’s Amanda Ball (Head of Global Clinical Operations) and James Lappin (Head of Clinical Compliance & Quality Assurance) at an upcoming partner seminar with qtec services GmbH focused on the impact IVDR has had on the industry. Details of ARC's expert opinion at the event are as follows: - Topic: IVD(R) in practice. Amanda Ball presents "A Journey through Clinical Performance Study startup and monitoring: A how to guide on best practices and pitfalls." and James Lappin presents "CDx performance study requirements and submissions under IVDR" - Location: Hamburg, Hotel Steigenberger, Heiligengeistbrücke 4, 20459 Hamburg - Date: 25th September – 26th September Haven’t got your ticket yet? Get your tickets here: https://bit.ly/4cDM089 Can't wait until late September for regulatory support? Write to us: https://bit.ly/4f6QR3B"

🔍 Help Us to Help You! - At ARC Regulatory we’re conducting important research to better understand the needs of laboratories involved in clinical research, particularly in IVD validation and testing. Your insights can make a difference! By participating in our short survey, you’re helping us to identify the key challenges and opportunities in the lab industry. And, as a thank you to all survey participants, you will receive an overview of our findings. 👉 Share Your Thoughts: https://bit.ly/4e1H8dj Let’s work together to improve lab research! #ARCRegulatory #IVDValidation #LabNeeds #ClinicalResearch #CustomerFeedback #HelpUsHelpYou