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The NEW EudraVigilance System and the electronic reporting of Cars in the ISO/ICH E2B(R3) format: Hanson Training Course Date:1921 November 2018Location:Chteauform College, Paris, Racecourse # 18521OVERVIEW
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The wwwemaeuropaeuendocumentsform new eudravigilance system is an electronic system for the reporting and monitoring of adverse reactions and other safety issues related to medicinal products in the European Union.
Marketing authorization holders, national competent authorities, and the European Medicines Agency (EMA) are required to file reports through the new eudravigilance system.
Users can access the system using their EMA credentials and follow the instructions provided in the user manual to fill out and submit reports.
The purpose of the new eudravigilance system is to enhance the safety monitoring of medicinal products and improve the communication between regulatory authorities and marketing authorization holders.
Information such as adverse reaction reports, periodic safety update reports, and risk management plans must be reported on the new eudravigilance system.
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