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Overview

Short Course Registration: 8:00AM-12:00PM


If you were notified today, would your organization be ready for an EU inspection of its pharmacovigilance system? With the recent shift to risk-based inspections, do you know what health authority inspectors look for when they conduct safety inspections? And what is the role of the labelling team in the process? This short course focuses on the preparations necessary for labeling teams in the EU ahead of pharmacovigilance inspections. Industry representatives will discuss the goals of end-to-end labeling compliance oversight. The MHRA Inspectorate will share their extensive and well-documented pharmacovigilance inspection process and their perspectives on inspection readiness and common findings.

Return to Global Labeling Conference.

Learning objectives

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

  • Describe considerations from industry on pharmacovigilance inspection readiness
  • Discuss the Inspector perspective on common findings and areas for improvements in compliance