EMA Offers Guidance on Virtual Pharmacovigilance Inspections

In the event a natural disaster or other crisis prevents onsite drug safety inspections, inspectorates and marketing authorization holders should have a plan for conducting virtual inspections, the European Medicines Agency says.

The letter announcing the inspection should clearly state the technical requirements and preparation process, and telecommunications arrangements should be tested in advance, according to a “points-to-consider” document posted on the agency’s website Feb. 18.

The amount of documentation and how it will be provided — e.g., via Eudralink or the EMA portal — should also be determined ahead of time, the EMA says, adding that a thorough pre-inspection document review may help target questions during the inspection interview.

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