Pharmacovigilance Strategies Workshop

The sources that inform pharmacovigilance actions continues to expand. One broad source is Real-World Data (RWD), which is data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. It becomes Real-World Evidence (RWE) when analysed and utilised as clinical evidence about a medical product's usage and potential benefits or risks. RWE compliments the data collected from other sources like clinical studies to enable the generation of a more holistic picture. To quote the EMA, “In pharmacovigilance, it has become mainstay to use routinely collected data about a patient’s health status or the delivery of healthcare from a variety of sources other than traditional clinical trials to support decision-making”

This session will focus on the insight that pharmacovigilance can derive from the growing sources of data before diving into case studies on the utilisation of RWD and RWE.