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Title
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Room
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* ! New Developments in Premarketing and Postmarketing Safety Assessment
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H-Grand Ballroom B
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Date / Time
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Sponsor
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Type
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08/06/2001
2:00 PM
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3:50 PM
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Biopharmaceutical Section*, ENAR
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Invited
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Organizer:
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Yi Tsong, CDER, FDA
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Chair:
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Yi Tsong, CDER, FDA
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Discussant:
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3:20 PM - Robert O'Neill, CDER, FDA
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Floor Discussion
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3:45 PM
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Description
In recent years, risk assessment of a drug product became the focus of pharmaceutical regulation. With advances in computer technology and statistical methodologies, many new applications have been adapted into safety assessment of pharmaceutical products. This session gives three important presentations on new statistical methods employed by industry and regulators in planning and carrying out postmarketing surveillence.
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