Risk Management and Risk Minimisation studies conducted by a network of European countries
The DSRU has experience of establishing a network of PASS studies in several European countries. In some cases PRAC, the EMA’s pharmacovigilance committee, will expect risk management or risk minimisation studies to be conducted via a network of European studies.
This brief video explains how the DSRU undertakes these European Network Studies:
The model for these studies is displayed below, although this is for guidance only. A bespoke network is set up for each study.
The process is as follows:
- Allow PASS studies to be conducted in several EU countries by local partners with a good understanding of their different health care systems
- Increase the sample size
- Provide assurance that risk management and risk minimisation are working in a number of member states