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The NEW EudraVigilance System and
the electronic reporting of Cars in
the ISO/ICH E2B(R3) format:
Hanson Training Course
Duration:3 dislocation:European Medicines Agency (EMA)30 Churchill PlaceCanary
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What is form new eudravigilance system?
The new Eudravigilance system is a centralized European database that manages information on suspected adverse reactions to medicines.
Who is required to file form new eudravigilance system?
Marketing authorization holders and national competent authorities are required to file forms in the new Eudravigilance system.
How to fill out form new eudravigilance system?
Forms in the new Eudravigilance system can be filled out online through the EudraVigilance website using the provided templates.
What is the purpose of form new eudravigilance system?
The purpose of the new Eudravigilance system is to improve the monitoring and reporting of adverse reactions to medicines in the European Union.
What information must be reported on form new eudravigilance system?
Information such as the suspected adverse reaction, patient demographics, and details of the medicinal product must be reported on forms in the new Eudravigilance system.
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