Are you a company seeking to commission or collaborate in the conduct of a post-authorisation study (PAS)?

Do you wish to register a study in the EU PAS Register?

Are you considering applying for an ENCePP study seal?

Are you interested in the recommendations from the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) on safety signals?

Review the list of signals discussed

Big Data Curriculum tender call

The European Medicines Agency (EMA) is seeking to sign multiple framework contracts in three different lots for developing a Big Data Curriculum to enhance the skills of the EU regulatory network. The Big Data Curriculum is composed of the Data Science curriculum, Pharmacoepidemiology and Real-world evidence curriculum, Biostatistics and Clinical Trial Methodology curriculum and modules in the field of clinical trials. The contractors will develop trainings in these fields that will ensure the provision of first-rate trainings and enable regulators to apply the acquired knowledge in regulatory activities.

Deadline for tender submission: 31 May 2022

Related information: eTendering - Data (europa.eu)

Overview of the EU PAS Register post-authorisation studies performed in Europe between September 2010 and December 2018

An article written by ENCePP WG3 has been published with an overview of 1426 studies registered in the EU PAS Register from inception to December 2018. The analysis shows, that among the 1380 studies with adequate information, 65.4% were requested by a regulator, 82% were funded by a pharmaceutical company and 58.1% had a protocol published. 86% of the studies have an observational design, 2.1% of them are clinical trials and 26% of the 1227 observational studies are multi-database studies.

The authors provide suggestions on how to improve the register, e.g. by standardisation of data elements and provision of completion guidelines, which will be taken into account for the enhancement of the EU PAS Register that will be initiated later this year.  

Related information: Article | ENCePP WG3