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
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Content Summary Introduction
EV application requirements Login and logout of EVWEB Navigating the application
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 •
EVWEB •
•
XEVMPD •
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Latest internet browsers IE 11, Firefox and Chrome
Requires Internet Explorer 11 and below
xEVMPD
EVWEB Login
Display sections – Smaller computer screens
Display sections – Smaller computer screens
MAH View
NCA View
User details and log out
Work space
Work space
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
Upload/import R2 and R3 files
Summary •
EVWEB application technical requirements
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Login and logout of EVWEB
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Navigate the sections of EVWEB
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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
Further information/ Contact information 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 Follow us on
Create an ICSR. Validate ... Features in the create and send ICSRs section of EVWEB. ⢠How to ... Send a question via our website www.ema.europa.eu/contact.
should be able to understand how to create the following types of report using ... change in the causality assessment and any new or updated information on the case that .... Send a question via our website www.ema.europa.eu/contact.
Feb 19, 2018 - and healthcare organisations), by standardising the data elements for the transmission of ICSRs. It should be ..... Session Time Out. The EVWEB tool allows a maximum period of inactivity of 25 minutes before a user is automatically log
3 days ago - EudraVigilance (EV) is the European data-processing network and database management system for ... In addition EudraVigilance supports the Clinical Trials Directive 2001/20/EC and regulation EU ...... The Workspace screen acts as a tempo
Jun 23, 2017 - 6.1.2. Business process changes and resourcing requirements . ..... It is suggested that all impacted organisations should prepare plans ..... formats and the interface has been updated to the new software ... nullified if the pre-exis
Jun 23, 2017 - 5.2.3. EudraVigilance database management system (EVDBMS) . ...... In addition, the Agency will also change the way organisations and ... through a call for volunteers via the EudraVigilance Expert Working Group and the.
ICSR Export MLM service. Export previously ... Full Access to all data sent by their organisation (Sender based L3) ... Only the dates for extraction need to be set.
please visit the EMA website). ⢠Data from EudraVigilance are published in the European database of suspected adverse drug reaction reports. (ADRreports.eu ...
Q: What exactly will be the changes to monthly membership reporting? Currently ... Applications can be received electronically or by fax if necessary. Q: When ...
Under the new membership reporting process, which will become effective in ... contact the Information Technology division by email at: [email protected] to ...
Aug 2, 2017 - WEB-document publication. E-mail. End Jul 17. -. Completed. EMA. Inform that GVP Module VI revision 2 has been finalised and will become.
Sep 6, 2017 - Confidentiality, access to data and disclosure of results . ... and/or proposals for regulatory science activities through senior Agency management. ... of the Academia Framework, the European Network of Centres for ... The process excl
data sets. You will also go deep on the building blocks of R: vectors and functions ... career, John Taveras has consistently driven big insights and large scale ... For those who want to take it to the next level By Adriel Irons I use Excel on a con
Jan 9, 2018 - Administration. Jobs@EMA User-guide. Welcome to the 'Jobs@EMA' portal. We are very pleased for your interest in our vacancies. Below you will find some useful information to navigate through the .... and information on it (personal info
Apr 18, 2003 - tight-binding molecular dynamics and the Green's function method. We demonstrate a ... to manipulate the low-energy electronic properties of.
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