Considerations while Navigating Regulatory Pathways for Novel IVD Tests, Companion Diagnostics, & Precision Medicine, Addressing Clinical Trial Design & Validation of Technological Advancements, with Insights on Challenging International Regulations including EU IVDR & Asian Regulatory Pathways
As the In Vitro Diagnostic market continues to exponentially expand, blending science and technology in order to more quickly and effectively identify and diagnose illnesses, clinical and regulatory affairs executives are often required to forge new pathways, define and gather substantial clinical evidence to validate test utility and to present information to a wide array of regulatory authorities in such a manner that garners swift regulatory approval. Innovations in digital health and transformative machine learning algorithms, new biomarker developments and partnerships with pharmaceutical corporations for companion diagnostic tests as well as heightened awareness of the value of genetic testing in personalized medicine are all propelling clinical and regulatory requirements to the forefront of importance, to support not only regulatory approval but also commercialization and reimbursement. In addition, international regulatory frameworks including the EU IVDR are forecast to impact the diagnostic industry in a new and revolutionary way, resulting in the need for greater evidence, longer post-market surveillance and new certification of tests long considered the standard of care.
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