OBJECTIVES
This course aims to give you a knowledge and understanding of EMA’s EudraVigilance.
Specific highlights:
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EudraVigilance nature, purpose and features
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Eudravigilance reporting modules (post-authorisation and clinical trials)
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Recent changes to Eudravigilance pharmacovigilance system (XML formats and impacts to safety database set-ups, Access policy considerations, Signal detection requirements, Medical Literature Monitoring)
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Electronic ICSR preparation
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Medical product information
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What is the extended EudraVigilance Medicinal Product Dictionary (XEVMPD) and what does it provide
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Importance of XEVMPD data in the revised Eudravigilance system
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Applied rules and methods to populate the dictionary : electronic reporting through the ESTRI gateway
Eudravigilance, EMA, pharmacovigilance system, EU pharmacovigilance, EU regulations, SUSAR, safety database, adverse reactions, ADR, ICSR, MAH, reporting, post-authorisation, clinical trials, xEVMPD, EVMPD, Article 57, Signal detection, ESTRI
LEARNING OUTCOMES
At the end of this course, you will be able to:
know what EudraVigilance is, the purpose of it and what it supports
know to the reporting modules that EudraVigilance provides
know changes to Eudravigilance
XML formats and impacts to safety database set-ups
Access policy considerations
Signal detection requirements
Medical Literature Monitoring
prepare for Electronic reporting
know where to go to for further information
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90 minutes |
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Online based learning |
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English language |
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Certificate of Achievement |
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150 € |
REGISTER NOW
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