European Network Studies

28 February 2019

Conducting post-authorisation studies in more than one country has several advantages:

  • Local investigators will have a good understanding of the healthcare system in their country.
  • Increases the sample size
  • Such studies satisfy the regulatory requirement to conduct PASS or risk minimisation studies in several EU states
  • Provides assurance that risk management and risk minimisation are working in a number of member states

The DSRU conducts European network studies across a number of countries. We bring together a number of partner organisations, write the master protocol for the observational study and act as both a partner and network co-ordinator. The study is undertaken using local data sources in each country, following the master protocol as closely as possible. The DSRU team produces a master final report for the study as a whole.

The DSRU will maintain a presence in the EU post-Brexit

Find out more here