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Overview

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.

The UK’s leading Pharmacovigilance & Pharmacoepidemiology unit

Find out more about the DSRU’s European Network Studies from Dr Miranda Davies, in this short video:

Studies Model

The model for these studies is displayed below, although this is for guidance only. A bespoke network is set up for each study.

Studies Process

The process is as follows:

Advantages

  • 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