Upcoming RMRAS Webinar

Laboratory Developed Tests: What to Expect in 2025 and Beyond
Wednesday, December 4, 2024      12:00 pm - 1:00 pm

Synopsis:

The laboratory industry was upended earlier this year with the release of FDA’s Laboratory Developed Test final rule, which officially began the phaseout of the Agency’s long-standing enforcement discretion of laboratory developed tests. The deadline for the first phase is fast-approaching in 2025, but many laboratories are left feeling uncertain about what requirements are actually applicable to them, or if legal or political influences will relieve them completely. This webinar will provide actionable regulatory insights to help you prepare for next year and the years to follow.

Join us Wednesday, December 4 from 12:00 pm – 1:00 pm MT for a complimentary webinar to discuss regulatory insights into the final rule in preparation for the first deadline, as well as our expert analysis of of the potential legal and political impact on the implementation of the final rule.

In addition to learning how different LDTs are affected by the final rule, in this event you will also learn:

• The practical differences between LDTs and traditional IVDs
• How to have a compliant RUO and IUO test
• A comparison of CLIA and the 21 CFR 820 quality system requirements, including validation
• Current status and future implication of legal and political influences on the implementation of the LDT final rule

Speakers
Emily Becker, Chief Regulatory Officer, OnemataDC
Emily has a passion for helping innovative technology efficiently and compliantly reach the market – and stay there – to improve patient lives. Her career in Regulatory Affairs began at Reglera, which was acquired by Dohmen Life Science Services (DLSS) in 2012. She progressed from Intern to Senior Manager of Regulatory Affairs in five short years. Her rapid-trajectory career path exposed her to regulatory strategy and successful strategy execution for a variety of technologies and therapeutic areas. When DLSS was acquired by EVERSANA in 2017, Emily was made the company’s Regulatory Affairs Director, responsible for management and growth of the Regulatory Affairs Consulting team and the development, leadership, and execution of client regulatory strategy across the highly regulated medical device, pharmaceutical, biologic, combination product, and human tissue industries all over the globe. This responsibility included acting as the client liaison with the US Food and Drug Administration and similar International regulatory agencies. She was responsible for advising on GDPR compliance for clients performing clinical trials in the EU and also assumed the responsibilities of HIPAA Privacy Officer for both EVERSANA and client companies. In 2021 Emily co-founded OnemataDC, an industry-leading patient-centric regulatory and quality consulting firm, to make expert consulting services accessible to innovators of all sizes and stages.

Daniel Simpson, RAC, President and Founder, DxDR Consulting
Daniel has spent most of his 30 plus years of his professional career in the In vitro Diagnostic (IVD) industry.  Originally a microbiologist by training, Daniel developed IVDs for human and veterinary use for the early part of his career.  In 2008 he made the switch to Regulatory Affairs, Quality and Clinical Affairs and became the Director of Regulatory, Quality, and Clinical Affairs at Corgenix Inc in Broomfield Colorado.  Daniel served in this position for 14 years and grew the company’s product portfolio, regulatory compliance systems, and strategic partnerships.  During the COVID pandemic, Daniel started consulting with IVD companies interested in getting COVID tests through FDA Emergency Use Authorization (EUA).  As the Corgenix consulting business continued to grow, Dan realized that helping companies of all sizes get their innovative products on the market was indeed his true passion.  In 2022, Daniel became the Director of Regulatory Affairs at ERI Group, a full-service medical device consulting firm, and led the regulatory affairs consulting group.  During this time Daniel worked with both IVD and medical devices companies to make their product ideas into reality and navigate the complex worldwide regulatory framework.  Daniel currently serves as the President of RMRAS. Daniel, has recently joined DCN Diagnostics, a full service IVD services provider as Director of Regulatory Affairs and will lead their Regulatory Affairs consulting business.

This program is using Microsoft Teams.  To register, click here:
https://events.teams.microsoft.com/event/30fe6230-48f0-43d8-9255-20f6d576a389@97b63611-58c3-4c36-976d-e28e64b3d504
 
IF you have any questions or difficulty registering, please contact Nan Matthews, programs@rmras.org