• In pharmacovigilance, the ‘real world evidence’ (RWE) has been used for a very long time. Post authorisation studies are a useful tool in getting to know a possible adverse event better, in terms of type, severity, and incidence. Since the late 00’s, more attention has been given to RWE. With the medicines that are investigated for use in orphan indications, or in high level cancer therapies, the concept ‘RCTs are the golden standard’ has to be modified. RCTs in large populations for e.g. a rare disease are very costly and take a lot of time. This leads to high priced medicines that are too late for a lot of people. By using real world data (as well), these challenges are part of the solution. Hanneke Dominicus did finish the e-learning course of the IMI-GetReal project on Real World Evidence.