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

Presenters

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

Ravi Sadasivan, MS, Project Manager, Evidera