Measuring benefit and balancing risk: Strategies for the benefit-risk assessment of new medicines in a risk-averse environment
19-20th June 2008, Sofitel Lafayette Square, Washington DC, USA
Measuring the benefits and risks of medicines is the underlying theme whenever the development, review and regulation of new medicines are discussed. The CMR International Institute for Regulatory Science first looked specifically at methodology for Benefit-Risk (BR) assessment and at the communication of risk at two Workshops in 2002 and the current Workshop revisited both these themes. In the intervening years, the Institute has initiated a specific study and held special focus workshops to look at multi-criteria decision analysis (MCDA) as one of the models that can be applied to BR assessment.
A primary objective of the current Workshop was to ‘discuss whether a global framework for benefit-risk assessment is achievable and examine the opportunities and barriers that might be involved.’