This presentation provides a comprehensive overview of in vitro diagnostics (IVDs) and companion diagnostics (CDx), and how to navigate the complex landscape of IVD regulations, with a detailed exploration of the EU IVDR. Using real world examples, we cover the key routes to compliance, critical aspects of scientific, analytical, and clinical validity, and practical guidance through the IVDR decision tree.
Key takeaways include:
- The impact of IVDR on Pharmaceutical development
- Awareness of Global IVD Regulations & Associated Challenges
- Strategic approaches for Global compliance
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Ensuring samples get to where they need to be can be challenging especially if delivery scope is global. LabConnect’s global laboratory network offers a broad range of testing and capabilities with access to more points of service than any other central lab.
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With an overview of the Global IVD regulatory environment, this presentation aims to address key considerations for pharmaceutical development, emphasizing the clinical context of use and outlining pre-clinical, clinical, and post-market implications for successful integration of diagnostics.
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