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To incorporate the new format EMA implements several changes in EudraVigilance. These include adapting the EudraVigilance Gateway the secure electronic communication tool to exchange ICSRs to accept ICH E2B R2 as well as E2B R3 files new ICH ICSR format migrating all existing ICH E2B R2 ICSR data to the new ICH ICSR format redesign of EVWEB the web application for the electronic reporting and management of ICSRs in the ISO ICSR format using a new technology introducing new functionalities...
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05
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Who needs form new eudravigilance system?
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Healthcare professionals who are responsible for reporting adverse reactions or incidents related to medicinal products
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Pharmaceutical companies and drug manufacturers
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Healthcare institutions and organizations involved in patient safety initiatives
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What is form new eudravigilance system?
The new eudravigilance system is a system for reporting and monitoring the safety of medicines in the European Union.
Who is required to file form new eudravigilance system?
Pharmaceutical companies and regulatory authorities are required to file the form.
How to fill out form new eudravigilance system?
The form can be filled out online through the EudraVigilance website with the required information.
What is the purpose of form new eudravigilance system?
The purpose of the form is to monitor and report any adverse reactions or side effects of medicines in the EU.
What information must be reported on form new eudravigilance system?
Information such as the name of the medicine, the adverse reaction, and any relevant patient information must be reported.
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