Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition). William Gregory
(metrics); signal identification; analysis and workup mechanisms in place; specific signals and safety issues pending globally; the risk management system and business continuity/crisis management plans in place; post-marketing trials under way, and new indication trials for marketed drugs; safety training; and issues with health authorities (HAs).
He or she must review and sign Periodic Safety Update Report (PSURs/PBRERs) and other PV documents submitted to HAs. To succeed in this position, communication across the organization is critical! Good communication skills are needed to link the QPPV with management, drug safety, the rest of the organization, the European Medicines Agency (EMA) and member state HAs, deputy and national QPPVs, and so forth. There must be a formal job description, and many companies also have a formal, written contract with the QPPV. The person, often a medical doctor (MD), should have senior management’s ear.
Many companies, particularly small companies and generic houses, will outsource the QPPV to a Clinical Research Organization (CRO) or consultant. Although this is legal and feasible, the company and the QPPV must take the job seriously. Some QPPVs at CROs may be performing this function for 15 or more clients! Whether this is practical and wise is debatable. All delegation, both within the company and outsourced, must be rigidly and carefully documented. The specific delegated functions must be written down and all parties must sign off. Note that all companies with MAs must have a QPPV. This includes generics, over-the-counter products, and so forth. No exceptions.
The EU QPPV is not required to be part of the PV team. He/she can have a non-PV position with oversight of the PV organization and performance. In such circumstances, it is best to have the EU QPPV at least at the same hierarchy level of the head global PV.
Note: The CMO or the head global PV can also be the EU QPPV.
Frequent QPPV Inspection Findings by the EMA
Penalties can be severe and can include fines of up to 5% of the MAH’s EU sales, with further penalties if the problems are not promptly corrected. Civil and criminal penalties for the MAH and the QPPV are possible.
Frequently Asked Questions
Q: Why would anyone want to do this job?
A: Good question, and I’m not sure I have a good answer. Perhaps a combination of responsibility, power, the desire to have a meaningful job that makes an impact, a good salary (though some say they could never be paid enough to do this job), visibility, and the like. For people who like and accept being empowered (and who really are empowered), and who like playing a fascinating role with interactions in all areas and in all levels of the company and with health authorities, this can be a marvelous job. Until something bad happens. Then the stress level rises and it truly becomes a 24/7 job, particularly in the age of the internet, with instant communications and media knowledge of problems. Word of problems and misbehavior travels quickly.
Q: Why would anyone not want to do this job?
A: Good question also! As specified before, such responsibilities could become a 24/7 job with real and stressful roles and responsibilities, particularly if the QPPV does not have the full support of the company. As icing on the cake, two legal consequences must be emphasized: First, even after the EU QPPV transitions to new responsibilities or a different organization, he or she will still be responsible for a safety issue that occurred during his or her tenure as EU QPPV. Any decision/measure, taken (or not taken) during the EU QPPV tenure can be challenged at any time and that individual will be committed “forever”. In other words, one can be prosecuted ten, twenty or more years after leaving the EU QPPV post. Second, as an EU QPPV and in case of a major safety issue, you can face criminal charges. In such a situation, it would be too late if you did not, before the issue arises or at the start of your QPPV tenure, secure a commitment of well-financed legal support from the MAH. Many EU QPPVs have tried to include such a protective statement in their contract, but most often, the company is reluctant to accept ... Have fun!
Q: What do I do if I am QPPV but not empowered and cannot get management to act on the appropriate needs, resources, and safety issues?
A: Quit. First, do your utmost to convince management that this is serious business and certain things must be done. You may need to get allies to make the case (e.g., the regulatory and legal colleagues in the company or an outside auditor). Point out the key sections from the EU Regulations. Document fully in writing everything you have done and everyone notified (and when), all items, actions, resources, and so forth, that you have requested, plus the responses. Always do and say the right thing and document it. Give it a reasonable attempt and length of time to get actions and corrections. It helps to have a forceful type-A personality. If all fails, update your CV and get a new job. You’ll sleep better and your gastric acid and blood pressure will return to normal.
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The Uppsala Monitoring Centre
The Uppsala Monitoring Centre (UMC) is a not-for-profit foundation that operates the WHO Programme for International Drug Monitoring and maintains both a drug dictionary, WHODrug Global, and a post-marketing safety database, VigiBase. A third UMC database contains WHO-ART, an adverse reaction terminology that is being sunset. The UMC also provides many research publications and services related to pharmacovigilance.
WHO Programme for International Drug Monitoring
Ten founding government safety organizations created the WHO Programme for International Drug Monitoring in 1968 following the thalidomide birth defect tragedy. To prevent recurrence of another such tragedy, the concept was to systematically collect