Global Forum for Qualified Persons for Pharmacovigilance (QPPV)

One of the critical PV processes is establishing, assessing and implementing risk management systems and evaluating the effectiveness of risk minimization. Module XVI of the EMA GVP guidelines is completely dedicated to risk minimization measures and provides guidance on measuring the effectiveness of risk minimization measures both at the level of implementation of the activities but also at patient level (outcome indicators). However, this part of the guidelines still raises many questions. This session will explore the expectations of the regulators towards the measurement of effectiveness but also on when to stop activities. In addition, we will focus on the tracking of additional risk minimisation activities at a global level with examples from our industry colleagues.