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Overview

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


If a government investigator knocks on your door today, would your organization be ready for an inspection of your pharmacovigilance system? This short course will help familiarize you with the FDA inspection process so that an inspection can be effectively hosted and proactively managed. Hear two FDA experts and an EU expert explain how to be inspection ready, the Inspector’s expectations, and common missteps that result in observations. In turn, learn perspectives from an industry veteran on what to do before and during an inspection. Course instructors will share practical and actionable commentary that you can use to improve and sustain your pharmacovigilance quality system.

This short course may be taken as a separate session or as a preparation for the afternoon course, Pharmacovigilance Inspection Part 2: Response, Measurement, Resolution, and Tracking.

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

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Learning objectives

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

  • Explain the purpose behind pharmacovigilance inspections and their benefit(s)
  • Describe the US and EU inspection processes and the differences/commonalities between the two
  • Explain how to be inspection-ready
  • Outline common inspection observations, including common EU findings
  • Interpret messaging in FDA Untitled Letters and Warning Letters and EU inspection findings