IVD Survival Guide: Navigating Uncertainty in the US and European IVD Regulatory Landscape

In vitro diagnostic (IVD) testing has become a cornerstone of modern medicine, with an estimated 70 percent of medical decisions made based on laboratory test results. Given the vital role IVDs play in guiding care, regulatory agencies frequently review approval requirements, and the regulatory frameworks governing these devices are constantly evolving.

The issuance of new regulations, guidance documents and regulatory proposals makes it critically important for IVD developers to proactively navigate uncertainty so that they are adequately prepared to mitigate the potential financial, compliance and operational risks that may surface in a dynamic regulatory environment.

The attendees will gain insights into FDA’s proposal for regulating laboratory-developed tests (LDTs) as IVDs, FDA’s reclassification for high-risk IVDs, important changes introduced by the EU In Vitro Diagnostics Regulation (IVDR) and latest developments on the transition to EU IVDR compliance.
In this webinar, the expert speakers will also cover changes that have been proposed or implemented in US and EU IVD regulations and provide strategies for developers to adapt to the ever-changing landscape.

Register for this webinar today to gain insights into how regulatory guidance can help IVD developers proactively navigate uncertainty and mitigate potential financial, compliance and operational risks.

Speakers

Charlie Chrisawn, Executive Director, Diagnostics, Premier Research

Charlie Chrisawn has spent his entire career focused on diagnostic development and has amassed over 15 years of experience designing and leading diagnostic trials including sample collection, validation and utility studies. Mr. Chrisawn’s background consists of both small- and large-scale diagnostics studies, including management of all development stages of diagnostics across a range of study settings. Under Charlie’s leadership, Premier Research celebrated a milestone achievement of enrolling 100,000 participants in their diagnostic studies worldwide.

Mr. Chrisawn’s programs have successfully garnered MA and 510(K) approvals, including the only FDA-approved screening test for colorectal cancer and the first FDA-cleared at-home test for COVID-19. Mr. Chrisawn has also enabled dual 510(k)/CLIA study execution and drug/device combination studies in the 505(b)(2) pathway. His expertise includes protocol and study design, domestic and international study startup, site management, sample accountability, staff training and study closure.

Mr. Chrisawn earned a Bachelor of Science (BS) degree in Biology from Davidson College.

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Michael Edwards, Sr. Director, Regulatory Affairs, MedTech, Premier Consulting

Michael Edwards is a Senior Director of Regulatory Affairs (MedTech) at Premier Consulting. Premier Consulting is a strategic product development and global regulatory consulting business unit of Premier Research, dedicated to supporting the specialized needs of emerging biotech, specialty pharma and medtech companies. Premier Research is a leading clinical research company that is Built for Biotech℠ and Made for MedTech™.

Michael has more than 25 years of experience in regulatory affairs and quality assurance acquired within the medical device and clinical research industry across a diverse range of medical device technologies and therapeutic disciplines, as well as organizations from start-ups to multinationals.

Michael’s expertise spans the complete product lifecycle including clinical research, design, development, technical support, project management, operations and business development in the medical devices sector. His knowledge of the device development process combined with the regulatory requirements enables him to provide a balanced interpretation of the pre-market and post-market needs and expectations of regulatory authorities.

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