Unified in our mission for independent studies to monitor benefits and risks
ZEG Berlin was invited by the European Medicines Agency to be a founding partner of ENCePP (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance). ENCePP’s aim is to strengthen monitoring of the benefit-risk balance of medicinal products in Europe. It does so by facilitating the delivery of high quality, independent, post-authorisation studies and developing and maintaining methodological standards and governance principles in research. ENCePP’s mission is ZEG Berlin’s mission. Since joining ENCePP, ZEG Berlin has complied strictly with the ENCePP Code of Conduct, with all eligible studies being awarded the ENCePP seal.
ZEG Berlin maintains its own Standard Operating Procedures (SOPs) to govern critical aspects of our daily work. SOPs are reviewed regularly and updated as needed. We also create study-specific working procedures outlining study conduct for all project, data and event validation staff.
All documents and procedures take account of the relevant rules, laws, regulations and quality assurance measures, including:
- Complying with the respective relevant good practice guidelines, such as Good Pharmacoepidemiology Practice (GPP), Good Epidemiology Practice (GEP), Good Pharmacovigilance Practice (GVP) and Good Clinical Practice (GCP)
- ENCePP Code of Conduct
- Conducting regular site audits during study conduct
- Undertaking regular internal quality audits
- Attending regular in-services and training opportunities to stay abreast of changes in the quality assurance environment