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EMA Revises Remote Pharmacovigilance Inspections Guide | Aspen Xchange
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The EMA has refreshed its points to consider document on remote pharmacovigilance inspections during a crisis, such as the current COVID-19 pandemic. The revisions to the document are minor and mostly relate to the preparation phase ahead of a pharmacovigilance inspection when an on-site inspection would not be feasible due to a crisis. In the revised document, EMA has replaced the term “distant/virtual” with “remote” and has expanded its explanation of a crisis situation that would prevent an on-site inspection from being conducted. One of the biggest changes to the document is the emphasis on the need to determine whether a marketing authorization holder has the technical capabilities to facilitate remote access to their electronic systems and maintain communication with inspectors.
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