Increasing scientific standards, independence and transparency in post-authorisation studies: the role of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance
Pharmacoepidemiology and Drug Safety, 05/11/2012
Blake KV et al. – It is envisaged that application of the ENCePP study concept will result in an increase in trust in post–authorisation studies of medicines. The register of studies will allow for ready access to study protocols and results, thereby enhancing transparency and facilitating review. Through the network, standards, transparency and clarity of relationships, ENCePP is expected to add to the European Union capacity to conduct robust post–authorisation studies, thereby benefiting public health.