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IVD Clinical Trials: Essential Components for Product Launch in 2019 & Beyond

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Date/Time

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As in vitro diagnostic (IVD) markets and regulations change, it’s imperative to stay up-to-date on clinical trial components that are required to facilitate efficient, cost-effective market approvals. During this NAMSA-sponsored webinar, Kristin Jones, MS, CCRA (Principal Medical Research Manager), will discuss the essential mechanisms that must be addressed throughout IVD clinical studies regardless of product type or intended market launch territory.

Highlighted will be:

  • – An overview of clinical trial processes;
  • – Key elements of clinical strategy such as scope of claim, intended use and regulatory pathway;
  • – Components that are essential for clinical study design such as protocol development, site selection, sample/specimen type requirements and selection of patient populations; and
  • – Regulatory considerations and expectations for IVD studies from the U.S. Food and Drug Administration (FDA), In Vitro Diagnostic Regulation (IVDR) and other global standards.
  • *By registering for this event, you are providing NAMSA consent to contact you directly regarding NAMSA’s services. The information you are providing will be processed by NAMSA to better understand your product needs and interests. At any time, you can submit a request to withdraw your consent for the use of information provided by you by contacting us at: communications@namsa.com. For additional information, please visit our Privacy Policy or contact us at privacy@namsa.com. NAMSA uses a third-party provider, GoToWebcast, to host NAMSA webinars. For information related to GoToWebcast’s privacy policy and utilization of information, please contact GoToWebcast directly.