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Omni Shoreham Hotel

Sep 11, 2016 2:00 PM - Sep 11, 2016 5:00 PM

2500 Calvert Street NW, , Washington, DC 20008 , USA

Course 2: Pharmacovigilance Inspections and the Impact on Labeling


Short Courses are not included in the conference registration and require a separate registration fee.

Short Course Registration: 9:00AM-5:00PM

The labeling process within a company is subject to a pharmacovigilance inspection, and the inspection findings will have an impact on the labeling. This short course will present the perspectives of industry and the regulatory inspector on how to prepare for the inspection and what can be done to answer major findings.

Return to DIA Global Labeling 2016

Featured topics

  • Why and how the EU/ICH PV modules are impacting labeling
  • PV inspection and labeling
    • Inspector viewpoint
    • Industry viewpoint
  • How to create a baseline of implementation of labeling changes
  • How to track labeling changes from end-to-end from the industry perspective
  • How companies implement end-to-end labeling tracking
  • Learnings from inspections and implementations
  • Round table question and answer

Learning objectives

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

  • Discuss the importance for regulatory and global labeling of an EMA PV inspection
  • Describe how to prepare for the inspection and what questions to expect
  • Identify the impact on regulatory and global labeling of the EMA PV inspection, bringing back to company valuable information on EMA PV inspection and impact on regulatory labeling

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