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browse by categories     Audio Conference Archive     Audio Conferences     Past Conference Documentation     Webinar Archive     Webinars     Workshops product FDA Overview of Statistics 101 for IVD Companies This product was added to our catalog on Tuesday 26 May, 2009. Item #: Price:  $395.00    Product description 90 Minute Webinar Recording Speakers Estelle Russek-Cohen, Ph.D Marina Kondratovich, Ph.D Arkendra De Mathematical Statisticians, Division of Biostatistics, Office of Surveillance and Biometrics/Center for Devices and Radiological Health, FDA The webinar will cover statistical principles associated with clinical studies for establishing performance of In Vitro Diagnostic Devices. It is geared to individuals who work with companies that may want to submit medical devices for clearance or approval from the FDA. The webinar will include key elements for planning a clinical study including the importance of the intended use and a pre-specified protocol and sample size, consideration of issues such as the role of banked specimens or data from outside the US, and common pitfalls. The webinar has an initial overview, a talk covering elements of what to ask FDA when planning a study, how to report the results of the more common diagnostic tests, and then examples that illustrate problems associated with study biases and study conduct. Then there will be an opportunity for discussions over the web. It is expected that webinar participants will have a previous exposure to terms such as sensitivity and specificity and 95% confidence intervals. However advanced training in statistics is not expected. Cost The cost to purchase the video recording is $395. Once your order is processed you will shipped a copy of the video file on flash drive. The video comes in windows media format and can easily be played on your computer.

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