Introduction to EVWEB Training Module EV-M3b An agency of the - - PowerPoint PPT Presentation

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Introduction to EVWEB Training Module EV-M3b An agency of the - - PowerPoint PPT Presentation

EV Reporting process for users: Introduction to EVWEB Training Module EV-M3b An agency of the European Union Content Summary Introduction EV application requirements Login and logout of EVWEB Navigating the application Summary 1 Content


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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

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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

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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

Follow us on @EMA_News