Module 12 Presentations

How to submit to xEVMPD

xEVMPD message = xEVPRM (extended EudraVigilance Product Report Message)

Online data-entry • Advantage: Free tool • Disadvantage: not possible to re-use data → big effort for maintenance

Option1

EVWEB

Submission through tool (RIM) • Advantage: Internal database • Disadvantage: Not free

Option2

Gateway

The Organisation for Professionals in Regulatory Affairs