EV Reporting process for users: Export functions in EVWEB Training Module EV-M3c
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Content Summary Introduction Implementation of the Access Policy in EVWEB ICSR Export – L2A/L2B (Pharmacovigilance obligations) ICSR Export MLM service
Export previously sent ICSRs Summary
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Content Summary Introduction Implementation of the Access Policy in EVWEB ICSR Export – L2A/L2B (Pharmacovigilance obligations) ICSR Export MLM service
Export previously sent ICSRs Summary
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Introduction: Target audience • Target audience for this training module: − 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-M3c training module you should be able to understand: • Implementation of the Access Policy in EVWEB • ICSR Export – L2A/L2B (Pharmacovigilance obligations) • ICSR Export - MLM service • Export previously sent ICSRs
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Implementation of the Access Policy in EVWEB •
National Competent Authorities •
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Full Access to all data held in EudraVigilance (L3)
Marketing Authorisation Holders •
Full Access to all data sent by their organisation (Sender based L3)
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Partially restricted access to ICSRs sent by other organisations where they concern suspect drugs for which they hold Marketing Authorisation. This product must be entered and validated in XEVMPD in order for the access to be granted (Pharmacovigilance obligations – Level L2A & L2B)
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All other ICSRs that do not fit in the above two categories will have restricted access (L1)
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No Access to Clinical Trial data apart from sender based
Implementation of the Access Policy in EVWEB •
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Sponsors of clinical trials •
Full Access to all data sent by their organisation (Sender based L3)
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All other ICSRs will have restricted public access (L1)
The EudraVigilance system updates the list of MAHs that are permitted L2A/L2B access for every ICSR in the database, this is carried out each night.
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MAHs do not need to set filters for substance or products names to perform the Export of ICSRs. Only the dates for extraction need to be set.
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Dates for extraction are based on the date of recoding any suspect drug substance or product names within an ICSR against Art57/XEVMPD
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Summary • Implementation of the Access Policy in EudraVigilance • ICSR Export – L2A/L2B (Pharmacovigilance obligations) • ICSR Export - MLM service • Export previously sent ICSRs
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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
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Export functions in EVWEB - European Medicines Agency - Europa EU
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.
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