Events

Clinical Trials Information System (CTIS): Walk-in clinic - March 2024

This walk-in clinic on CTIS functionalities provides an opportunity for sponsors to receive practical information about the Clinical Trials Information System by asking questions to CTIS experts in real time.

Online
European Medicines Agency, Amsterdam, the Netherlands
Live broadcast
Data iniziale: 12 Marzo 2024, 16:00 (CET)
Data finale: 12 Marzo 2024, 17:00 (CET)
Event Human Clinical trials Regulatory and procedural guidance
Multi-stakeholder webinar on the HMA-EMA Catalogues of real-world data sources and studies

This event provides an overview of the HMA-EMA Catalogues of real-world data sources and studies including their benefits and significance in regulatory practices.

Online
European Medicines Agency, Amsterdam, the Netherlands
Live broadcast
Data iniziale: 4 Marzo 2024, 10:00 (CET)
Data finale: 4 Marzo 2024, 12:00 (CET)
Event Human Data on medicines
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
Data iniziale: 4 Marzo 2024
Data finale: 8 Marzo 2024
Event Human Clinical trials
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