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An agency of the European Union
EV Reporting process for users: Introduction to EVWEB
Training Module EV-M3b
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Content Summary
1
Introduction
EV application requirements
Login and logout of EVWEB
Navigating the application
Summary
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Introduction
EV application requirements
Login and logout of EVWEB
Navigating the application
Summary
2
Content Summary
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Introduction: Target audience
• Target audience for this training module:
− Users of EVWEB
− National Competent Authorities (NCAs) in the European Economic Area (EEA)
− Marketing authorisation holders (MAHs)
− Sponsors of clinical trials (Sponsors)
− Research institutions/Academia
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Introduction: Learning objectives
Following the completion of EV-M3b training module you should be able to understand:
• EVWEB application technical requirements
• Login and logout of EVWEB
• Navigate the sections of EVWEB
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EV application requirements
• XEVMPD
• Requires Internet Explorer 11 and below
• EVWEB
• Latest internet browsers IE 11, Firefox and Chrome
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xEVMPD Login
Log in with EMA unique credentials
select the organisation on behalf which actions need to be performed
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xEVMPD
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EVWEB Login
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Display sections – Smaller computer screens
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Display sections – Smaller computer screens
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Log in with EMA unique credentials
select the organisation on behalf which actions need to be performed
EVWEB Login
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MAH View
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NCA View
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User details and log out
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Work space
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Work space
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Sections
Create and send ICSR (E2B(R3) format)
WebTrader – Inbox and Outbox
ICSRs
Post – EVPOST
Rerouting rules -NCA only
MedDRA
Bulk export for MAHs L2A/L2B access policy
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Upload/import R2 and R3 files
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Summary
• EVWEB application technical requirements
• Login and logout of EVWEB
• Navigate the sections of EVWEB
• Use the basic functions of the application
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Feedback
• Please provide us with feedback on this E-learning module and any attendant guidance documents you have viewed by taking the EMA training survey.
• The survey is accessible via this link.
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Thank you for your attention
European Medicines Agency
30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact
Further information
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