ICH E2B (R3) EudraVigilance

April 2018
Author: Prashant Dhanavade, Sciformix Corporation

While the EMA has done much to improve the EudraVigilance (EV) system, there have been some technical challenges which have resulted in increased effort, time, and cost to marketing authorization holders (MAHs). The main benefit of E2B(R3) over E2B(R2) is capturing of detailed data, and it provides options for inclusiveness, standardization of data, and collaboration with other stakeholders. It also focuses on the implementation of software and tools for creating, editing, sending, and receiving electronic Individual Case Safety Reports (ICSR) messages.

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