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REGISTRATION FORM The NEW EudraVigilance System and the electronic reporting of Cars in the ISO/ICH E2B(R3) format #18524 1315 June 2018, ChteauformCollege, Paris, France Please register online at
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How to fill out form new eudravigilance system
How to fill out form new eudravigilance system
01
Log in to the EudraVigilance system using your credentials.
02
Click on the 'New Case' tab to start filling out a new form.
03
Enter the required information such as the patient's details, suspected medicinal product, and adverse event details.
04
Attach any relevant documents or files to support the case.
05
Review the information entered and make sure all fields are filled out correctly.
06
Submit the form to complete the process.
Who needs form new eudravigilance system?
01
Pharmaceutical companies
02
Healthcare professionals
03
Regulatory authorities
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What is form new eudravigilance system?
The new eudravigilance system is a pharmacovigilance system for monitoring and reporting adverse reactions to medicines in the European Union.
Who is required to file form new eudravigilance system?
Marketing authorization holders, sponsors, and regulatory authorities are required to file form new eudravigilance system.
How to fill out form new eudravigilance system?
Form new eudravigilance system can be filled out online through the EudraVigilance system by providing all the required information about the adverse reaction.
What is the purpose of form new eudravigilance system?
The purpose of form new eudravigilance system is to collect and monitor information on adverse reactions to medicines to ensure patient safety.
What information must be reported on form new eudravigilance system?
The information reported on form new eudravigilance system includes details of the adverse reaction, patient information, and details of the medicine.
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