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EudraVigilance Training Programme
EudraVigilance - electronic reporting of Individual Case Safety Reports (ICSRs) training
Participants who pass the EudraVigilance knowledge evaluation following this three day training course will receive a EudraVigilance knowledge evaluation notification that will allow them to register with EudraVigilance and to report ICSRs to the European Medicines Agency and/or the National Competent Authorities in the EEA.
By the end of this training course, you should be able to do the following within the context of EudraVigilance:
- Apply ICH rules to safety reporting
- Describe the Registration process with EudraVigilance
- Understand the concepts of electronic transmission of ICSRs
- Describe the EudraVigilance Gateway
- Describe the Webtrader functions
- Explain the reporting processes for fully-automated organisations, Post-function users, and EVWEB users
- Create, validate and send safety messages
- Create, validate and send follow-up reports, nullification reports, literature reports, parent-child reports and study reports
- Reports with medical and drug history
- Apply EudraVigilance business rules
- Create and send acknowledgments of received ICSR messages
- Query, view, browse and download safety reports
- Query, view and browse MedDRA through the EVWEB
The training courses dates are accessible here.
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Last update: Tuesday, 5 July 2016. |
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