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
Expand types of appropriate studies
Registries vs Pharmacoepidemiologic Studies
Pharmacoepidemiologic SAFETY Studies– Include prospective data collection & LSS
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
Reporting of Safety Signals
Clarify temporal sequence of– Hypothesis generation
– Hypothesis testing
– Perspective of risk and benefit
– Risk management
Surveys
Design– Cross sectional or longitudinal
Require epidemiologic expertise & other academic disciplines
Analytic Methods for Risk Management
Methods development needed– Signal detection & evaluation
– Risk assessment
– Risk management evaluation
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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