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