The Role of Quantitative Science in Medicine Safety and Pharmacovigilance: A focus on Post-authorization challenges
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*Frank W Rockhold, GlaxoSmithKline 

Keywords: Safety, Pharmacovigilance, Post-Marketing

Once large scale trials are completed and a new medicine is approved for patient access, the attention of the safety process shifts to signal detection and evaluation in the real world. We will review the major methodological developments over the past dozen years or so leading to current industry and regulatory agency practice in signal detection and evaluation in the post-marketing environment. This session will also examine some of the ongoing and future developments in post-marketing safety assessment of data and how those have resulted in a shift in the roles within industry leading to the need to allocate more resources to look into post-marketing safety data in a more systematic way. The communication about the benefit to risk and management of risk is an equally important topic what will continue to challenge us all and some examples will be reviewed. The overall goal is to simulate the audience’s thinking about how the work of “safety” is not completed at the time of submission, but rather just beginning.