Webinar Overview

Since November 2005, an EU Risk Management Plan (EU-RMP) has been mandated as part of the marketing application for all new chemical entities in the EU. In the EU-RMP, the safety profile of the medicine has to be described and the pharmacovigilance activities proposed during the post-marketing period. These activities include, e.g.,  collection of spontaneously reported adverse events and post-authorization safety studies (PASS).

There is relatively little known on the temporal trends of post-marketing requirements in the EU, on the relative frequency and types of PASS authorized (e.g. Phase IIIB Open Label, cohort study, etc), or on safety concerns (e.g. important identified risks; important potential risks; or important missing information) identified by drug type.

This Webcast will provide an overview of recent trends in EU PASS, including an analysis of a sample of EU-RMP summary data, description of PASS types requested and comparison/contrast of characteristics between drug types.

Implications for Pharmaceutical Companies and lessons learnt will be discussed.



Who Should Attend

  • Medical Affairs
  • Drug Safety
  • Pharmacoepidemiology
  • HEOR
  • Benefit Risk/Safety Research
  • Corporate strategy

Key Learning Objectives

  • Real world information on current PASS characteristics and trends
  • Implications for new marketing applications in the EU


David E. Neasham Ph.D, MSc, MFPH, EU Director and Senior Research Scientist, Health Economics and Epidemiology

Ravi Sadasivan, MS, Project Manager, Evidera