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