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Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system

EudraVigilance is the EU's system for managing and analysing information on adverse reactions to medicines which have been authorised or are being studied in clinical trials in the European Economic Area (EEA) and supports the reporting and analysis of suspected adverse reactions originating from clinical trials and the post-authorisation phase of...

Online
Start date: 2 December 2024
End date: 6 December 2024
Event Human Clinical trials
Fifth EMA/HMA Big Data Stakeholder Forum
Online
European Medicines Agency, Amsterdam, the Netherlands
Live broadcast
Start date: 28 November 2024, 09:30 (CET)
End date: 28 November 2024, 17:30 (CET)
Event Human Medicines
Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system

EudraVigilance is the EU's system for managing and analysing information on adverse reactions to medicines which have been authorised or are being studied in clinical trials in the European Economic Area (EEA) and supports the reporting and analysis of suspected adverse reactions originating from clinical trials and the post-authorisation phase of...

Online
Start date: 26 November 2024
End date: 28 November 2024
Event Human Clinical trials
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