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9th Annual Clinical Affairs and Regulatory Approvals for Diagnostics Conference

Gathering as an Industry to Exchange Insight on the Innovation Accelerated by the Precision Medicine Initiative, Co-Developing and Commercializing Companion Diagnostics with Therapies, Maintaining Compliance in Rapid Point-of-Care Testing, and Preparing for LDT Oversight
December 5 & 6, 2016 | Alexandria, VA | Hilton Alexandria Old Town


Fueled by the sequencing of the human genome, the use of technology to aid decision making and analysis, as well as the dawning of the era of Personalized Medicine, diagnostic tests have gained tremendous traction in the healthcare industry. The surge in available diagnostic testing has enabled physicians to tailor treatment to the individual genome of patients, increase the speed of diagnosis, treatment, and ultimately improve quality of care. As diagnostic technologies continue to advance and become increasingly accessible, manufacturers must remain at the forefront of accurate and effective clinical data and regulatory adherence in order to stay competitive in the global marketplace.

The 9th Annual conference will delve into the implications of recent and impending guidance and regulations, highlighting co-developing companion diagnostics and therapeutics, complex NGS testing, EU IVDD, informed consent, experimental use, and emergency use authorization. Other key areas of discussion include designing and analyzing bridging studies, adoption of global standards for rapid diagnostic testing, and aligning clinical activities with regulatory needs. Through case-study driven presentations, interactive workshops, high-level keynote sessions, as well as provocative roundtable panel discussions complemented by multiple networking opportunities, the program will foster a sense of industry-wide collaboration.


This conference has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.


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