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Overview

*Short Courses require an additional registration fee. You do not need to be registered for the forum to attend*

This Short Course will be offering in a virtual format only


Regulatory inspections assessing marketing authorisation holder compliance with pharmacovigilance legislation are not new. So why do inspections often seem like a marathon, with crowds of people and a race to the finish line? Organisations strive to be perpetually “inspection ready” but this is often not reflected in the inspection experience.

How might we create a world where inspections are “non-events”, where our perpetual proper prior planning prevents poor performance and inspection findings become a thing of the past? If you’re going to run a marathon you don’t just prepare for the week beforehand…. Regulatory inspections require investment, poor outcomes can have significant implications, so why run the risk of failing to prepare.

Topics to be covered include:

  • strategies that can be built into day-to-day processes to enable an always-inspection-ready mindset
    • frameworks for proactive compliance oversight
    • pragmatic risk-taking in PV policy decisions and process design
    • pre-emptive documentation of decisions and associated rationale
    • routine front-room preparedness
  • knowing when and how to respectful challenge inspection findings
  • developing pragmatic and right-sized CAPA plans to resolve identified non-compliance without over committing or gold-plating compliance

Learning objectives

At the conclusion of this session, participants should be able to:
  • Analyse the maturity of their company’s pharmacovigilance inspection preparedness
  • Implement tools and strategies to establish a proactive state of inspection readiness
  • Identify cross-functional stakeholders in pragmatic resourcing and responses to inspections