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Reference Documents



EudraVigilance Courses | Reference DocumentsFAQs 

The following reference documents will be used during the training course. It is not mandatory but recommendable to familiarise with them and to have access to them on a portable memory device during the course.

EudraVigilance–Electronic Reporting of ICSRs:

Read Maintenance of the ICH Guideline on Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports E2B (R2)

Read Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use (CT-3)

Read Note for guidance–EudraVigilance Human: Processing of Safety Messages and Individual Case Safety Reports (ICSRs)

Read Implementation Plan for the “Note for Guidance–EudraVigilance Human: Processing of Safety Messages and Individual Case Safety Reports (ISCRs)

Read Guideline on Good Pharmacovigilance Practices (GVP)–Module VI: Management and Reporting of Adverse Reactions to Medicinal Products

Extended EudraVigilance Medicinal Product Dictionary:

Read Detailed Guidance on Electronic Submission of Information on Medicinal Products 

Additional Resources:

Read ICH E2D–Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting


European Medicines Agency Information Day:

Registered attendees of the European Medicines Agency Information Day can access presentations here.