Network of European Studies

eu-member-flags-_crop_smallRisk 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 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.

EU network studies figure

 

The process is as follows:

EU network studies flow chart

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

See Saad Shakir’s blog on a network of European studies.

 

For further information or a discussion without commitment, please contact us.