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Holiday Inn London Kensington Forum

Feb 21, 2017 8:00 AM - Feb 22, 2017 12:00 PM

97 Cromwell Road, London, SW7 4DN, United Kingdom

Post-Authorisation Studies

This course offers insight into EU legislation on PASS and PAES. Examples of PAS protocols as well as some examples of classic pitfalls in study conduct will be presented and discussed.

SESSION 3: METHODOLOGY

Session Chair(s)

Michael  Forstner, PhD, MPH, MSc

Michael Forstner, PhD, MPH, MSc

Head of Global Safety Science

SOBI, Switzerland

  • Cohort and field studies
  • Registries with primary data collection
  • Registries based on secondary use of data
  • Case control studies
  • Issues with multi-country PASS
  • Bias and confounding examples

Speaker(s)

Michael  Forstner, PhD, MPH, MSc

METHODOLOGY

Michael Forstner, PhD, MPH, MSc

SOBI, Switzerland

Head of Global Safety Science

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