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International Society for Pharmacoepidemiology (ISPE)

International Society for Pharmacoepidemiology (ISPE). International scientific forum for epidemiologists and safety experts working in regulatory, academia, and industry www.pharmacoepi.org. Clarification of Definitions. Quantitative Definition of Risk Numerator & denominator Time element

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International Society for Pharmacoepidemiology (ISPE)

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  1. International Society for Pharmacoepidemiology (ISPE) International scientific forum for epidemiologists and safety experts working in regulatory, academia, and industry www.pharmacoepi.org

  2. Clarification of Definitions • Quantitative Definition of Risk • Numerator & denominator • Time element • Expand types of appropriate studies • Registries vs Pharmacoepidemiologic Studies • Pharmacoepidemiologic SAFETY Studies • Include prospective data collection & LSS

  3. Safety Signals • Line 319 #8 • Refer to background risk of AEs from underlying disease? • Line 352 #2 • RR or OR to evaluate causality • Important to consider Risk Difference as well • Many strategies may not be appropriate for spontaneous reports

  4. Reporting of Safety Signals • Clarify temporal sequence of • Hypothesis generation • Hypothesis testing • Perspective of risk and benefit • Risk management

  5. Surveys • Design • Cross sectional or longitudinal • Require epidemiologic expertise & other academic disciplines

  6. Analytic Methods for Risk Management • Methods development needed • Signal detection & evaluation • Risk assessment • Risk management evaluation

  7. International Society for Pharmacoepidemiology (ISPE) 19th International Conference on Pharmacoepidemiology & 1st International Conference on Therapeutic Risk Management 21-24 August 2003, Philadelphia

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