The Real4Reg study was registered in the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) database, a network coordinated by the European Medicines Agency.
ENCePP aims to strengthen the monitoring of the benefit-risk balance of medicines, primarily by facilitating the conduct of high-quality, multi-centre, independent post-authorisation studies (PAS) with a focus on observational research.
The Real4Reg EU PAS register can be consulted through this link:. ENCePP database.
Following its adherence to the ENCePP Code of Conduct and internationally recognized guidelines, the Real4Reg study has been awarded an ENCePP Seal. The ENCePP Seal is awarded to studies in the EU PAS Register that uphold high standards in pharmacoepidemiology and pharmacovigilance research, ensuring scientific independence, transparency, and robust methodologies, thereby minimizing potential biases or avoiding conflicts of interest.