Network of European Studies
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 in 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:
Advantages of these networks of European studies:
- 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
For further information or a discussion without commitment, please contact us.