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Activity Number:
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290
- Drug Safety Monitoring in a Complex World-Wide Regulatory Environment - Strategy Meets Methodologies
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, July 31, 2018 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract #330847
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Presentation
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Title:
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Specific Safety Monitoring Tools and How This Will Benefit Drug Safety
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Author(s):
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James Buchanan*
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Companies:
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Covilance LLC
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Keywords:
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Drug safety;
Risk;
Tools
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Abstract:
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The process by which safety clinicians evaluate data looking to identify product risks requires appropriate statistical tools. Unfortunately, few safety monitoring tools are routinely used and those that are utilized may not be fully understood by the clinicians using them. The field of drug safety monitoring would be advanced by the development of a suite of tools that can be broadly applied by industry and regulators alike that offer advanced capabilities. This session will discuss efforts to develop such tools by collaboration between statistical and clinical scientists.
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Authors who are presenting talks have a * after their name.
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