ACRP 2010
MDCI to Present Session on IVD Clinical Trial Management at ACRP 2010 Global Conference
Written by: Lisa KingThursday, November 12th, 2009 | FDA Medical Device Regulations | No Comments
Jacqueline Barrows, Clinical Trial Manager, and Ron Warren, Principal Regulatory Consultant, will present “Regulatory and Clinical Trial Management for IVD Studies” on Saturday April 24, 2010, during the ACRP 2010 Global Conference in Tampa, FL.
Their presentation will provide an overview of the FDA regulations for in-vitro diagnostic (IVD) submissions and the challenges that sponsors and sites may encounter when conducting and managing an IVD clinical trial. These challenges can include issues of proper site selection, as IVD clinical trial venues can vary from the laboratory, to point-of-care settings, and at patient bedside. Proper data collection during an IVD study is also addressed, with discussion of user acceptance and IVD use by non-medical personnel. Clinical study monitors, project managers, site managers, and any others involved in overseeing IVD clinical studies will benefit from this program.
For additional detail and registration information, visit http://www.acrp2010.org.
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