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Short Course* Registration: 8:00AM-5:00PM

The regulatory authority has just completed an inspection of your pharmacovigilance system and left you with a list of inspection observations. As you wait to receive the inspection report, when and how should you respond? Well-reasoned, complete, and timely responses are key to more positive outcomes of an inspection – in fact, they may make a difference in the final classification of an error or the type of regulatory correspondence issued. This short course will familiarize you with the principles and practical methods of planning and preparing an effective response to inspection observations, including: coordinated response preparation, assessment of underlying causes, development and implementation of corrective and preventive action plans (CAPAs), measurement, and tracking. Through hands-on case studies, you will have the opportunity to develop responses and action plans for the US and EU and to receive feedback on your work from regulators and qualified professionals.

*This short course follows on from the morning course, Pharmacovigilance Inspections Part 1: Readiness, Conducting, Findings, and Report-Outs, but can also be taken as a separate session.

*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:

  • Describe common pharmacovigilance inspection observations
  • Explain principles and guidelines for planning and preparing responses to inspection observations
  • Plan and conduct a response to inspection observations, including development of a CAPA, measurement, and tracking