EudraVigilance - Electronic Reporting of ICSRs in the EEA

This course provides training on how to use EudraVigilance, the European data-processing network and management system established at the European Medicines Agency. The system supports the electronic exchange, management, and scientific evaluation of Individual Case Safety Reports (ICSRs) related to all medicinal products authorized in the European Economic Area (EEA).
EVWEB is an Internet-based reporting tool developed by the European Medicines Agency. It allows small and medium size enterprises that hold marketing authorizations in the EEA, as well as sponsors of clinical trials, to electronically report adverse reactions in full compliance with the internationally agreed standards to the European Medicines Agency and National Competent Authorities (NCAs).

• Pharmacovigilance and drug safety Marketing Authorization Holders (MAHs)
• NCAs with legal reporting obligations in the EEA
• Qualified persons for pharmacovigilance
• Pharmacovigilance experts
• Data entry professionals
• Medical coding professionals
• Those interested in electronic adverse reaction reporting
• Contract research organizations

Participants who complete this course should be able to:

• Apply ICH rules to safety reporting
• Describe the EudraVigilance Gateway
• Describe the Web Trader functions
• Explain the reporting processes for fully automated organizations, 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
• Study reports
• Reports with medical and drug history
• Create and send acknowledgments of received ICSR messages
• Query, view, browse, and download safety reports
• Query, view, and browse MedDRA through the EVWEB

How to use EudraVigilance system with regard to ICSRS:

• Acquiring a robust base in the fundamentals of the electronic reporting of ICSRs
• Understanding electronic transmission of ICSRs and the International Conference on Harmonization (ICH) M2 safety and acknowledgment message specifications
• Understanding and applying the ICH E2B(R2) specifications on clinical safety data management using good pharmacovigilance practices and current EudraVigilance Business Rules
• Hands-on experience with the EudraVigilance reporting capabilities and query functions