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.