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

10^th Revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology published

The 10^th annual Revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology by the ENCePP Research Standards and Guidance working group has been published under EMA’s coordination. The 10^th Revision includes two new chapters on the use of artificial intelligence in pharmacoepidemiology (Chapter 15.5) and on real-world evidence and pharmacoepidemiology (15.6), and a new comprehensive Annex 2 on Methods for the evaluation of medicines in pregnancy and breastfeeding. Besides the updating of nearly all existing chapters, including considerations on methodological standards for COVID-19 studies, two chapters have been extensively revised: Comparative effectiveness research (15.1) and Vaccine research (15.2). Recommendations on the use of statistical significance for the interpretation of evidence have been added in the Overview of study designs (4.1). The Foreword from the co-chairs of the ENCePP Steering Group highlights the continued involvement of ENCePP in sound pharmacoepidemiological research, including into COVID-19, and real-world evidence studies. This 10^th Revision of the Guide provides a useful resource for researchers, regulators, marketing authorisation holders and applicants.

Related information: ENCePP Guide on Methodological Standards in Pharmacoepidemiology

Metadata list describing real-world data published on the EMA website

A list of metadata describing real-world data sources and studies has been publish on the EMA website, to help pharmaceutical companies and researchers to identify and use such data when investigating the use, safety and effectiveness of medicines.

Following extensive consultation with stakeholders, including ENCePP members, the chosen metadata will be included in a catalogue of data sources containing information about existing real-world databases (to replace the current ENCePP catalogue) and information about the studies performed on the data sources (to replace and enhance the current EU PAS Register). Setting up a catalogue of data sources and enhancing the catalogue of studies aims to improve transparency with regard to observational studies, enhanced discoverability of studies and data sources, and contribute to increasing the ability to judge the evidentiary value of studies when used to investigate the use, safety and effectiveness of medicinal products.

Related information: HMA/EMA Big Data Steering Group

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