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