Abstract
Formal benefit-risk evaluation has taken on new importance both during the development of new drugs and during marketing ever since the adoption of the Development Safety Update Report (DSUR), the new Periodic Benefit Risk Evaluation Report (PBRER) and new formats for the Risk Management Plan (RMP). A key principal of benefit-risk evaluation is to bring all forms of expertise to bear on the assessment of both risks and benefits. Nonclinical and clinical safety scientists, pharmacists and physicians have an important role to play in these evaluations and bring complementary skills to the scientific, mechanism-based assessments of safety and efficacy information. This session seeks to create a forum for free exchange of ideas and information from nonclinical and clinical experts on how we can improve patient safety and the balance of benefits and risks. An overview will be presented on the new landscape for benefit-risk evaluations and how these assessments are used in international reports such as the DSUR, PBRER and in national and regional RMP’s. The viewpoints of a hospital pharmacy division on patient safety will be presented followed by a perspective on some of the latest work in hypothesis-directed nonclinical toxicity studies. These will be followed by a discussion from a clinical perspective on patient safety and practical advice on how nonclinical safety experts can contribute to risk minimization.
