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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.