Overview

This Solution Provider Webinar is brought to you by DIA in cooperation with

Sciformix

On November 22, 2017, EMA went live with a new and improved EudraVigilance database which was accompanied by updates to GVP Module VI (ICSR and Safety Reporting) and Module IX (Safety Signal Management). While the attempt to harmonize and standardize safety processes is welcomed, some functionality is not working as expected and there have been some unintended consequences of the changes which have led to an increased workload for many MAHs.

EMA has provided updates and fixes to help resolve the issues and a major upgrade is scheduled in February. Around the same time, the EudraVigilance Data Analysis System (EVDAS) pilot will be complete and fully implemented, so this is a good time to examine all aspects of this new update.

Continuing Education Credits are not available for this event.

Featured topics

EudraVigilance latest updates: what’s new and what to do next
EVDAS updates: it’s use and implications on signal management activities
Industry perspective: how a leading pharma company is preparing for this change

Who should attend?

Professionals who work in the area of:

Pharmacovigilance and Risk Management professionals, including members of,
- Pharmacovigilance operations
- ICSR Submission teams
- Signal Management and safety surveillance teams
Regulatory Affairs
Chief Medical Officers
Heads of Clinical Operations

Learning objectives

At the conclusion of this webinar, participants should be able to:

Understand the recent changes in EudraVigilance
Understand what worked and did not work as planned with the changes
Evaluate the implications of the changes and their impact on safety operations
Apply knowledge and lessons learned from leading safety and risk management industry experts

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