Attaining good patient health outcomes (HO) is the underlying purpose of any health care intervention, including drug therapy. The measurement of HO is the basis for evaluating the quality of health services, and a key element in determining the value of health interventions. Along with effectiveness, long term safety is an important component of HO of new authorised human medicines. The explicit assessment of the sustained benefit-risk trade-off of new authorised products must be undertaken to ensure that unintended harmful consequences are not offsetting the intended clinical benefits. Spontaneous reporting schemes provide a means of continuous surveillance of medicines that is important for raising early signals of safety concerns, but ad-hoc post-authorisation safety studies (PASS) may be necessary to evaluate the safety of medicines more accurately. The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) is an initiative led by the European Medicines Agency aimed at further strengthening post- authorisation medicines research in Europe by facilitating the conduct of multi-centre, independent PASS focusing on safety and on benefit/risk. Specifically, ENCePP provides a unique point of access for all involved stakeholders seeking collaboration for the commissioning or the conduct of PASS. This is achieved by offering access to available expertise and research experience in the fields of pharmacoepidemiology and pharmacovigilance across Europe brought together into a functioning network of excellence. It is anticipated that ENCePP will add to knowledge and the EU capacity to conduct PASS studies in the light of shared methodologies and expertise. In doing so, ENCePP can serve as a bridge between medicines regulation and HO research in supporting risk/benefit management planning to minimise adverse events and maximise the benefit of marketed medicines.