Filter by
News (153)
RSS
The annual Plenary (hybrid) meeting of ENCePP will take place at the EMA on Friday, 1 December 2023, from 09:00 to 16:00. This year, participants will continue reflecting on the future of ENCePP, including how to place the work of ENCePP in the broader context of a changing regulatory environment.
The minutes of the virtual ENCePP Steering Group (SG) meetings held on 20 June and 5 October 2023 have been published.
EMA is looking for new data partners to collaborate with DARWIN EU® - the Data Analysis and Real-World Interrogation Network. Deadline for expression of interest: 31 October 2023.
The 11th Revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology has been published, in collaboration between EMA and the ENCePP Research Standards and Guidance Working Group.
The annual report covers the full list of activities performed in 2022, as well as statistics on the ENCePP Guide, the ENCePP website and the EU PAS Register.
DARWIN EU® call for new data partners
DARWIN EU® Coordination Centre, in collaboration with EMA, has launched an open call for expression of interest from potential data partners.
DARWIN EU®
The European medicines regulatory network is working to develop a new electronic public catalogue of data sources and studies.
ENCePP Plenary webinar
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.
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.
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.
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 authors provide suggestions on how to improve the register.
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.
The European Network of Centres in Pharmacoepidemiology and Pharmacovigilance (ENCePP) will hold its virtual annual plenary meeting on 18 November 2021.
Registration is open to ENCePP Partners (centres and networks) until 26 October 2021.
The 9th Revision has been extensively amended and re-organised with an improved structure. The foreword from the co-chairs of the ENCePP Steering Group highlights the importance of the Guide in the context of the COVID-19 pandemic and vaccination campaigns.
The European Medicines Agency has published a new Call for tenders for Real World Data Subscription
The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) published a procurement procedure today for setting up a framework to support better decision-making throughout the lifecycle of medicinal products.
In its CONSIGN-International document, the Consortium describes ongoing initiatives and opportunities for international collaboration in the area of medicines use and their effects on management of COVID-19 in pregnancy.