European Medicines Agency publishes second work package of benefit-risk methodology project

News 13/10/2010

The European Medicines Agency has published the report on the second work package of its benefit-risk methodology project. This represents the finalisation of the second step of the Agency's five-step project, which aims to make its decision-making on the benefits and risks of medicines more transparent, more consistent and easier to audit.

The second work package set out to assess the suitability of the tools and processes currently used in benefit-risk assessments for medicines regulation. The report reviews a number of existing approaches for balancing benefits and risks and how these approaches might be used to aid regulatory decision-making on medicines. It also makes recommendations on which models should be field-tested during the third stage of the project.

The project started in early 2009 and is being conducted in collaboration with experts in decision theory from the London School of Economics and Political Science (LSE) and with the University of Groningen. It is scheduled to run until the end of 2011.

How useful was this page?

Add your rating