hero image

On January 18 of this year the UK Medicines and Healthcare Products Regulatory Agency (MHRA) released a short new document from the Office of Compliance and Inspection covering Distant/Virtual pharmcovigilance (PV) inspections of Marketing Authorization Holders (MAHs) during a crisis situation.  See: https://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/02/WC500138892.pdf

For some time now the MHRA has indicated that it may do routine “virtual” or “distance” PV inspections of MAHs.  In a July Q&A https://www.mhra.gov.uk/Howweregulate/Medicines/Inspectionandstandards/GoodPharmacovigilancePractice/Frequentlyaskedquestions/index.htm in question 7, the MHRA indicated that it might do a distance inspection if the MAH does not have a UK site: “…then a ‘virtual’ inspection may be performed. This may involve the MAH hiring temporary office space in the UK, or alternatively, the inspection being performed via teleconferences.”

The UK inspection process is a complicated one consistent with other EU PV inspections.  In a nutshell, the MHRA contacts the MAH (or inspectee) and indicates they want to do a PV inspection.  A date is agreed upon and a large amount of information describing the PV system, approved/authorized products and other company details is sent usually on a CD or DVD.  A document called the Summary of PV Systems is also prepared and sent.  The MAH may then decide to do or not do the inspection based on the data received.  If they do decide on an on-site inspection, then the inspection unfolds as expected.  Alternatively they may be satisfied with the the data received and doing additional teleconferences or videoteleconferences” – a virtual inspection.

The MHRA, in the new document, now has released further information on how they will do virtual inspections in crisis situations.

“Crisis” refers to situations where the safety of the inspectors is question or if there are transport restrictions.  Examples include pandemics, national disasters and, interestingly, inspections in high criminality areas.  In these circumstances, a distance or virtual inspection would be done if the various internal UK government departments agree.  Virtual inspections would not be done if high risk MAHs are concerned.

The standard procedures for MHRA PV inspections would be followed with certain changes:

More documents may be requested in the pre-inspection communications than would be requested for an on-site inspection.  Normally, during a site inspection, MHRA requests additional documents when they arrive and during the inspection.  This is done both to get information that is now needed but also to test the company’s ability to produce valid safety information on the spur of the moment.

Attention should be paid to documents that may need to be translated.  The MAH should request that only key documents be translated.

The type and amount of documentation should be decided in advance and the MHRA may put in their schedule additional document review time in order to be better able to ask pertinent and focused questions during the interviews.  Line listings and case files should be requested and received in advance.  This is usually contrary to the on-site practice of asking for and reviewing these documents during the inspection.

Comments and Observations

A virtual inspection may indeed be beneficial for both the MHRA and the inspectee.  There is less stress, less travel and less time lost.  The inspectors can work from their own offices and the company does not have to physically mobilize as much as it would if several inspectors were on site.

Some people do not do as well on the phone and prefer face to face interviews.  Skilled interviewers will often say that it is better to do an interview in person as one can watch and evaluate body language, gestures etc.  The phone is often harder for non-native speakers to use than in person conversations.

On the other hand, the interviewee can have assistants and “coaches” in the room (using a speaker phone or extensions) to help in tricky moments.  The interviewer can also have coaches in the room!

The company should alter its preparations and training of personnel to account for the fact that the conversations will not be face to face.  Training should then be done using phones.  This is very common in language courses, particularly immersion courses, where some of the classes are done by phone.  This is always harder than in person training as the ability to watch the speakers face and lips is lost and often the phone connection is less than ideal.  The sound quality may be distorted, particularly on internet (VOIP) connections.  The interviewee also cannot see the questioners face to get an idea of whether the responses are satisfactory.  “Pregnant pauses” during the conversation can also be more disruptive to the interviewee.

It may also be necessary for the company to demonstrate its safety database in real time.  The IT group may need to assist in setting up access at a distance in order for the MHRA to watch a demo (but, of course, not to have free access to the live company database).

If there is indeed a crisis ongoing, the best laid plans may go awry.  Expect trouble and be sure the support teams are available to correct any bugs, problems, connectivity issues etc.

As in all inspections, expect the unexpected, have everyone on emergency call and be ready to “run” to get additional, unexpected documents, interviewees and other surprise requirements.

It might also be useful if the MAH has an internal audit/quality team that does PV audits or mock inspections to do some virtual inspections if they do not do so already.  The company itself must treat a virtual inspection with the same seriousness and gravity it would with an on-site inspection.  The legal ramifications can be just as severe.

US companies with UK or EU affiliates or business partners should be aware of this and may be required to participate in such inspections.

It will be interesting to see how this plays out as both companies and government become virtual!

Related Articles