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Activity Number:
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408
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 1, 2007 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #308946 |
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Title:
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Some Thoughts on the Variables in Communications on Medical Device Studies Between the Sponsor and the FDA from the View of the Statistical Consultant
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Author(s):
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Dennis King*+
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Companies:
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STATKING Consulting, Inc.
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Address:
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759 Wessel Drive Unit 6, Fairfield, OH, 45014,
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Keywords:
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Medical Device ; FDA ; Statistical Consulting
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Abstract:
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During the period from Pre-IDE to PMA submission, the Sponsor and the FDA committees have many face-to-face and telephone communications concerning the Sponsor's medical device development program. Statisticians are employed by the Sponsor as the Sponsor's representative in the statistical matters related to the medical development program. The progress and effectiveness of these conversations is dependent on many variables including the level of involvement of the consultant in the Sponsor's company, the experience of the consultant and the experience level of the other personnel (both Sponsor and FDA) involved in the communication. This talk will explore these and other variables in the communication process.
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