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22 January 2018 EMA/249220/2016 Inspections, Human Medicines Pharmacovigilance & Committees DivisionEudraVigilance User Manual Individual Case Safety Report conversion 1.130 Churchill Place Canary
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How to fill out eudravigilance user manual
How to fill out eudravigilance user manual
01
To fill out the EudraVigilance user manual, follow these steps:
02
Go to the EudraVigilance website and log in to your account using your credentials.
03
Navigate to the 'User Manual' section on the website.
04
Download the user manual in PDF format.
05
Open the downloaded user manual on your computer or device.
06
Read the manual thoroughly to understand the instructions and guidelines for using EudraVigilance.
07
Follow the step-by-step instructions provided in the user manual to complete the necessary sections.
08
Ensure you enter all the required information accurately and according to the guidelines.
09
Save your progress regularly to avoid losing any data.
10
Once you have filled out all the required sections, review your entries to verify they are correct.
11
Submit the completed user manual as per the instructions provided in the manual or on the EudraVigilance website.
Who needs eudravigilance user manual?
01
The EudraVigilance user manual is needed by individuals or organizations who are using the EudraVigilance system for reporting and monitoring adverse events or suspected side effects of medicinal products.
02
This can include healthcare professionals, such as doctors and pharmacists, pharmaceutical companies, regulatory authorities, and other stakeholders involved in pharmacovigilance activities.
03
The user manual provides guidance on how to navigate the EudraVigilance system and complete the necessary documentation accurately and efficiently.
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What is eudravigilance user manual?
Eudravigilance user manual provides guidance on how to use the Eudravigilance system for reporting and evaluating suspected adverse reactions to medicines.
Who is required to file eudravigilance user manual?
All Marketing Authorization Holders (MAHs) are required to file eudravigilance user manual.
How to fill out eudravigilance user manual?
Eudravigilance user manual can be filled out online through the Eudravigilance system using the provided templates and guidelines.
What is the purpose of eudravigilance user manual?
The purpose of eudravigilance user manual is to ensure that suspected adverse reactions to medicines are reported and evaluated in a standardized and efficient manner.
What information must be reported on eudravigilance user manual?
Eudravigilance user manual requires reporting of information such as patient details, suspected medicinal product, adverse reaction details, and reporter information.
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