EMA advises on virtual pharmacovigilance inspections
Such spot-checks may be necessary in a crisis, where an inspector cannot be physically present
The European Medicines Agency (EMA) has issued practical guidance on conducting virtual pharmacovigilance inspections.
EMA admitted that such spot-checks may be necessary in a crisis, where an urgent inspection of a medicine or plant is required, but an inspector cannot be physically present. This could be because of a pandemics, natural disaster, or high crime risk, for instance. If an inspectorate decides a virtual check is necessary, EMA has suggested good practice guidance is followed.
This includes ensuring that reliable teleconference facilities are available during the inspection, and that telecommunications be tested in advance. Also, documents need to be requested early, to be submitted by EMA’s Eudralink or other agency IT systems.
And while translations may also be required, EMA accepts that this can be onerous for companies and only translation of key documents should be requested. EMA suggested that key documents should be saved onto a USB pen, ensuring confidentiality, in case the wireless connection is disrupted.