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Publications (7)
RSSOverview of the European post-authorisation study register post-authorization studies performed in Europe from September 2010 to December 2018
The European post-authorisation study (EU PAS) register is a repository launched in 2010 by the European Medicines Agency (EMA). All EMA-requested PAS, commonly observational studies, must be recorded in this register.
The ENCePP Code of Conduct: A best practise for scientific independence and transparency in noninterventional postauthorisation studies
The ENCePP Code of Conduct provides a framework for scientifically independent and transparent pharmacoepidemiological research. Despite becoming a landmark reference, practical implementation of key provisions was still limited.
Systematic overview of data sources for drug safety in pregnancy research
Systematic overview of data sources for drug safety in pregnancy research
The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance survey of methodologies for European Union publicly funded multi-database safety studies
The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance survey of methodologies for European Union publicly funded multi-database safety studies
ENCePP considerations of non interventional studies
ENCePP considerations of non interventional studies
Concept paper - Model for ENCePP
Concept paper - Model for ENCePP