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Thought papers |
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Pharmacovigilance and Signal Detection |
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| Abstract |
The pharmaceutical industry and regulatory agencies are striving to avoid product
withdrawals, with their associated costs in terms of litigation expenses, lost revenue,
falling share price, and tarnished company image.
Key to meeting that challenge is to set up a sound pharmacovigilance plan that
summarizes the safety profile of a product and specifies potential areas of risk to
investigate.
Companies must now look beyond the collection, assessment, and
reporting of adverse events and focus on signal detection and risk management.
They must adopt a formal signaling methodology that incorporates all relevant data
sources in order to better understand the risk-benefit ratio of a product and discover product–adverse event relationships.
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