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EudraVigilance Electronic Reporting of Cars in the EEA Course #11573 57 January 2011 Euro sites La Chappelle, Paris, France Course Goals The primary goals of this course are to allow Joint Initiative
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What is eudravigilance - dia?
Eudravigilance - Dia is the European Union's database for collecting, managing, and analyzing information on suspected adverse reactions to authorized medications.
Who is required to file eudravigilance - dia?
Marketing authorization holders (MAHs) are required to file eudravigilance - dia.
How to fill out eudravigilance - dia?
Eudravigilance - Dia can be filled out online through the EudraVigilance system following the guidelines provided by the European Medicines Agency (EMA).
What is the purpose of eudravigilance - dia?
The purpose of eudravigilance - dia is to monitor and assess the safety of medicinal products in the European Union, thereby ensuring the protection of public health.
What information must be reported on eudravigilance - dia?
Information such as suspected adverse reactions, patient demographics, medication details, and outcome of the reaction must be reported on eudravigilance - dia.
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