European Network Studies2018-12-06T10:15:27+00:00

Project Description

European Network Studies

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.

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

This brief video explains how the DSRU undertakes these European Network Studies:

European Network 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.

European Network Studies process

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

Contact Info

Drug Safety Research Unit Bursledon Hall, Blundell Lane, Southampton, SO31 1AA, U.K.

Phone: +44 (0)23 80 40 86 00

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