Insights for CT Sponsors: Navigating IVDR 2017/746 and CTR 536/2014

Insights for Clinical Trial Sponsors: Navigating IVDR 2017/746 and CTR 536/2014

Date & Time: 21 January 2026 from 04:00 PM to 05:30 PM (CET)

•The meeting will start at 03.00PM o’clock.•Audio is available either through your computer or through phone connection (dial-in).•Your line will be kept on mute.•At the end, there will be time for questions and you can submit your questionsthrough the ‘question’ box.•After the webinar, connect to the EUCROF eLearnIN platform (https://eucrof.eu)to retrieve materials, customer satisfaction survey and certificate of attendance.•At the end of the webinar, a Forum Discussion will be opened on the eLearnIN platform (https://eucrof.eu) to ask further questions to the speaker or start an open discussion on the topic of the webinar.

Overview

As the regulatory landscape for clinical trials continues to evolve, sponsors must adapt to the complex requirements introduced by the In Vitro Diagnostic Regulation (IVDR 2017/746) and the Clinical Trials Regulation (CTR 536/2014). This presentation provides a practical overview of the key compliance obligations under both frameworks, with a focus on IVDR compliant clinical trials. We will explore the implications for compliance, and regulatory submissions, highlighting common challenges and operational impacts. Attendees will gain actionable insights to support efficient trial planning and ensure alignment with current EU regulatory expectations.

Presenter:

Amber McNair is an Associate Director of Clinical Trials Regulatory Affairs at IQVIA, a leading global contract research organization (CRO). She brings nearly six years of specialized experience in clinical trial regulation, with a strong focus on biomarker-driven drug development and companion diagnostics.

Amber’s scientific foundation stems from her work managing global central laboratory operations, where she managed the development and implementation of companion diagnostic strategies across complex, multi-country clinical trials. Her expertise in in vitro diagnostic (IVD) compliance, particularly within the evolving EU regulatory landscape, gives her a distinctive perspective on the integration of diagnostics into clinical trial design and execution.

She is a board-certified Medical Affairs Advisor and a Registered Scientist with the UK Science Council, underscoring her commitment to professional excellence, scientific integrity, and regulatory reliability. Amber is a passionate advocate for precision medicine and plays a key role in aligning regulatory strategy with scientific innovation to support global trial delivery.

Her work continues to drive forward the regulatory frameworks that enable biomarker-led clinical research, ensuring that diagnostic and therapeutic development remain closely aligned in pursuit of improved patient outcomes.

Registration deadline: 20 January 2026 at 6 p.m.

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