The European Medicines Agency has scheduled an EudraVigilance and Signal Management Information Day for November 21, 2023, from 09:30 to 17:00 CET. This in-person event will take place at the EMA premises in Amsterdam.
This event will provide insights into the ongoing development of the EudraVigilance database and international initiatives influencing it. It will also cover the database’s management and maintenance.
Throughout the day, there will be discussions on data protection, the quality of Individual Case Safety Reports (ICSRs), and inspection findings. Additionally, new projects and initiatives, such as compliance reports and the Signal and Safety Analytics project, will be introduced, with direct implications for Marketing Authorization Holders.
Furthermore, the event will explore novel methodologies for signal detection and the future potential of utilizing artificial intelligence.
Registration is available until November 17, 2023. Please be aware that space is limited due to room capacity.
EMA encourages stakeholders to participate in this event to support effective management and utilization of EudraVigilance and the EU network pharmacovigilance network.
You can access the program and the registration form here: EudraVigilance and Signal Management information day | European Medicines Agency (europa.eu)
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