Strategies for communicating benefits and risks to decision makers: Explaining methods, findings and conclusions through a common language approach

17-19th June 2009, Washington DC, USA

Determining the benefit-risk (BR) balance of a medicine is one of the most important steps in its development, review and post-approval re-assessment.

This workshop was convened by the CMR International Institute for Regulatory Science (the Institute) to allow regulatory agencies and industry to share progress updates on their initiatives to development and implement a BR assessment framework and to investigate the characteristics of effective BR communication between sponsors and regulators.