DIA 2018 Global Annual Meeting

In the past, pharmacovigilance departments have often been limited in the way they interact with other functions within pharmaceutical organizations. The traditional function of the Safety organization has been to prevent harm to patients, and to react to emerging evidence of potential harm. Thus we have been reactive rather than proactive, and tactical rather than strategic.This is now changing. The growing emphasis on health technology assessment in the health care field requires strategic contributions from Safety. And expectations of a more patient-centered approach now mean that we must help patients manage their adverse drug reactions, in addition to simply characterizing and communicating risks. This session will describe how this transformation is taking place, resulting in a Safety organization that is a full strategic partner in development, and a key supporting function for commercialization. Strong, cross-functional safety governance is essential for effective decision making; means for assessing and improving safety governance maturity will be presented.

The session will also describe the evolving role of the safety statistician in helping multidisciplinary safety teams to think more quantitatively, and to improve the conversations we are having about safety evaluation during drug development.