Pharmacovigilance and Risk Management Strategies Conference

New data sources and methodologies are improving our ability to assess risk and risk-benefit balance associated with medical product use, but this information must be appropriately shared to facilitate decision making by all stakeholders, including health care providers and especially patients. How are risk and risk mitigation approaches most effectively shared with health care providers, and how can effective feedback on adverse events be best communicated to sponsors? What approaches to sharing benefit-risk information are most meaningful and useful to the patient in his or her decision making? What tools does FDA use to communicate with the public about drug safety and risks, and what impact have these messages had on health care professional and patient or consumer decision making? In this session, patient representatives and communication professionals from industry and FDA will explore how well current methods are working and how they can be improved.