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18th Annual

IVD Clinical & Regulatory Affairs Conference

March 16-17, 2027 | Alexandria, VA

18th Annual

IVD CLINICAL & REGULATORY AFFAIRS CONFERENCE

March 16-17, 2026
Alexandria, VA

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Navigating Global Regulatory Change, Evolving FDA Expectations, and European Union IVDR Revisions While Advancing Responsible AI, Clinical Evidence, Companion Diagnostics, and Laboratory Innovation

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Navigating Global Regulatory Change, Evolving FDA Expectations, and European Union IVDR Revisions While Advancing Responsible AI, Clinical Evidence, Companion Diagnostics, and Laboratory Innovation

Program Overview

As global regulations change, IVD manufacturers must adapt to a vastly different regulatory environment. The swiftly approaching EU IVDR has created a challenge for regulatory and clinical affairs professionals in the diagnostic space, as companies must find harmony between the multitude of different regulations in the EU, UK, Switzerland, Canada, China, and the US. Additionally, cybersecurity breaches have become a major focal point for the diagnostic industry, as different countries have created new regulations to maintain cybersecurity standards. With quality case studies and panel discussions regarding global regulatory changes and compliance strategies, the 16th Annual IVD Clinical & Regulatory Affairs Conference will continue to deliver a first-in-class educational and networking platform for diagnostic regulatory and clinical affairs executives.

Check out these other Q1 Productions upcoming events:

9th Annual

EU Medical Device & Diagnostic Reimbursement & Market Access Conference

February 2-3, 2027 | Virtual Event

Tri-Annual

Diagnostic Coverage & Reimbursement Conference

March 17-18, 2027 | San Diego, CA

Countdown to the IVD Clinical & Regulatory Affairs Conference:

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Experience the Quality First Difference.

Learn from Industry Leaders

An exclusive experience with professional thought leaders provides you with direct insight into current solutions.

Keep up with Industry Trends

Learn through dynamic panel discussions, case studies and real world evidence on current topics directly related to your industry.

Exchange Ideas & Network

We provide a platform for your team to ask questions with experienced industry experts. The key to building your knowledge and seeing things from another perspective.

Find Solutions that Work for You

Insight and interaction are at the ready for you and your team. Collaborate with your peers, utilizing their insight and experience to accommodate your common challenges.

“This is the best conference I have been to in years. I am completely impressed with the content and value I received in terms of information.”

Regulatory Manager, Quality & Regulatory Affairs, CARIS LIFE SCIENCES