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ENCePP News Archive




1 July 2022

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

 

The 10th 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 10th 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 10th 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

 

14 June 2022

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

 

22 April 2022

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)

 

3 March 2022

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

 

18 January 2022

EU PAS Register unavailable on 18 January from 18:00 to 22:00

 

Due to essential IT maintenance, the EU PAS Register will be unavailable on 18 January from 18:00 to 22:00 CET, and EU PAS studies cannot be registered or updated during this period. This work is part of planned maintenance to strengthen the security of the EMA's applications.

 

18 January 2022

ENCePP 2021 Activity report published

 

The ENCePP report on the network's 2021 activities has been published. The report covers the key achievements, short summaries of the meetings organised through the year, information on publications and some statistics on the EU PAS studies.

 

Related information: ENCePP 2021 Activity report

 

7 January 2022

ENCePP Plenary webinar report published

 

The report and the presentations of the ENCePP Plenary webinar held on 18 November 2021 have been published.

 

Related information: Report and presentations

 

4 January 2022

Joint HMA-EMA Data Standardisation Strategy (DSS) published

 

The joint HMA-EMA Data Standardisation Strategy (DSS) following its endorsement by the Heads of Medicines Agencies in November and EMA Management Board in December 2021 has been published. This is a major milestone achieved as part of the engagement in international initiatives set out in the Big Data Steering Group workplan.

 

The DSS sets out the principles to guide the definition, adoption and implementation of data standards according to the European medicines regulatory network needs related to data submitted throughout the lifecycle of medicinal products. The creation of the strategy enables faster uptake of data standards across the EU, will contribute to improve data quality and enable data linkage and data analysis to support medicine regulation. It will support the creation and implementation of internationally applicable data standards in line with the data pillar of the network strategy to 2025.

The DSS is a living document and will be maintained overtime to reflect changes in priorities and additions of new requirements.

 

Related information: European Medicines Regulatory Network Data Standardisation Strategy | Big Data Steering Group workplan | Regulatory Science Strategy to 2025

 

 

 

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