Companion diagnostics for personalized medicine is the most important emerging trend in the IVD industry today. Companion diagnostics will significantly impact not only the IVD industry but also the delivery of healthcare. In July, FDA released its draft guidance document regarding companion diagnostics, which offers the agency’s current thinking on this area. In an effort to provide further clarity on this matter, the editors of IVD Technology have put together a special Webcast on the regulation of companion diagnostics. The featured speaker for this Webcast will be Dr. Elizabeth Mansfield, PhD, the Director of the Personalized Medicine Staff at FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD). In this Webcast, Dr. Mansfield will discuss elements of the draft companion diagnostic device guidance. Dr. Mansfield will also cover the definition of a companion diagnostic, the types of IVDs that would and would not be considered companion diagnostics, the rationale for FDA’s policy, and labeling recommendations for both the therapeutic and diagnostics devices. After her presentation, Dr. Mansfield will participate in a Q&A session, during which attendees will have the opportunity to ask her questions about the regulation of companion diagnostics. You do not want to miss this important Webcast on companion diagnostics, an area that will influence the direction of the IVD industry for many years.

Date: November 10, 2011
Time: 11AM CT | 12PM ET
Webcast Duration: 60 minutes

Cost: $249.00


Elizabeth Mansfield, PhD
Director of Personalized Medicine Staff, Office of In Vitro Diagnostic Devices (OIVD) in the Center for Devices and Radiological Health, FDA

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Richard Park
Editor-In-Chief, IVD Technology

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Price Per Person: $249.00

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