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The ICH M14 Guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines, is open for consultation until 31 August 2024.
ENCePP membership list updating exercise until 31 July 2024.
Survey on needs, use and opinions on the topic of real-world data
EMA published a draft reflection paper for public consultation on use of real-world data in non-interventional studies to generate real-world evidence.
ENCePP SG 2024 kick-off minutes.
2023 ENCePP Plenary documents
The electronic Catalogues of RWD sources and studies, replacing the former ENCePP Resource Database and EU PAS Register have been launched.
The 2023 ENCePP annual report has been published, covering the full list of activities performed in 2023.
ENCePP Resource Database and the EU PAS Register to the new EMA-HMA Catalogues of data sources and non-interventional studies on the EMA website, the two databases will experience a downtime from 22 January to 15 February 2024.
The ENCePP Secretariat will remain closed from 18 December 2023 to 3 January 2024. During this period, the ENCePP Secretariat and the EU PAS Register mailboxes will not be monitored, and study, data source, centre and network submissions will be not reviewed.
The European Medicines Regulatory Network (EMRN) is developing new public electronic catalogues for data sources, studies, institutions and networks. The new catalogues will replace and enhance the current ENCePP Resources Database and the EU PAS Register.
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.