In the context of current EU pharmacovigilance legislation and EMA guidelines, Post-Authorization Safety Studies (PASS) are conducted after marketing authorization with the purpose of:
- Risk Characterization, or
- Evaluation of Risk Minimization.
This webinar will focus on the use of PASS in evaluating the effectiveness of risk minimization measures.
The presentation will show:
- The EU regulatory landscape
- Combination of qualitative and quantitative research methods
- Challenges of running surveys and drug utilization studies (DUS) across the EU
- Key elements for a successful risk minimization