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29 February 2024
EMA/204890/2017
Information Management DivisionEudraVigilance user declaration for qualified person for
pharmacovigilance/responsible person for EudraVigilance
The undersigned Qualified
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How to fill out new organization first user

How to fill out new organization first user
01
Log in to the organization's admin account.
02
Navigate to the user management section.
03
Click on the 'Add New User' button.
04
Fill in the user's name, email address, and other required information.
05
Set the user's role and permissions within the organization.
06
Verify the information entered and click on 'Save' to create the new user.
Who needs new organization first user?
01
Any organization looking to add a new user to their system for access and authorization purposes.
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What is new organization first user?
The new organization first user is typically the initial user or representative designated to manage or operate the newly formed organization.
Who is required to file new organization first user?
The designated representatives or officers of the organization, such as the founders or officials responsible for its establishment, are required to file the new organization first user.
How to fill out new organization first user?
To fill out the new organization first user, gather the necessary information about the organization, including its name, address, and details of the first user. Then complete the designated form by providing accurate and complete information as per the organization’s requirements.
What is the purpose of new organization first user?
The purpose of the new organization first user is to officially designate an individual who will have authority to act on behalf of the organization and ensure compliance with legal and regulatory requirements.
What information must be reported on new organization first user?
The information that must be reported includes the name of the organization, the contact details, the name and role of the first user, and any other pertinent information as required by filing regulations.
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