May 21 – 22, 2024 – Chicago, IL
Please join us as Beaufort’s SVP, Global Regulatory and Quality, Karin Hughes, Ph.D. will be presenting at the Q1 Productions 17th Annual IVD Clinical and Regulatory Affair Conference. Her presentation, “Exploring the Companion Diagnostic (CDx) Landscape, will focus on understanding and overcoming common clinical challenges in companion diagnostic development, including:
- Differences between EU and US regulations related to IVD clinical performance studies
- Navigating EU competent authority and ethics committee applications without coordinated assessment
- Planning for substantial modifications
- Interface between the regulations on clinical trials of medicinal products and IVDs
CDx regulations are constantly evolving, making it challenging to keep up with increasing compliance demands. Our experts understand the necessity of timely regulatory intelligence and are adept at navigating the ever-changing complexities associated with global regulatory frameworks around drug and diagnostic co-development. We will align your development efforts with regulatory expectations in the U.S., European Union, and Asia Pacific region.
Learn more about our comprehensive Companion Diagnostic services and solutions or Contact Us today.
About the conference:
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 17th 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.
Learn more here or register: https://www.q1productions.com/ivd-clinical-regulatory/