The roles and responsibilities of an EEA qualified person for pharmacovigilance (QPPV)
pharmafile | November 15, 2011 | Feature | Research and Development |
The roles and responsibilities of an EEA Qualified Person for Pharmacovigilance are based on the current Directive 2001/83/EC and Vol 9A of the Rules Governing Medicinal Products in the European Union. Vol 9A states that the QPPV is responsible for the “overall pharmacovigilance for all medicinal products for which the company holds marketing authorisations within the EU.”
The QPPV has three main areas of responsibility:
- to ensure the Marketing Authorisation holder has an appropriate pharmacovigilance system in place
- to have an overview of a safety profile for the products for which the company holds a Marketing Authorisation
- to be the point of contact with the competent authorities
It is stated in the Vol 9A guidance document that it is important that the QPPV is “appropriately qualified and to have documented experience in all aspects of pharmacovigilance.” There is no clear definition of what “appropriately qualified” is, however the person selected to fulfil these duties should have knowledge and experience in working in pharmacovigilance, enabling them to implement and maintain a good pharmacovigilance system. As a QPPV is pivotal to a company’s pharmacovigilance operations, it is required that the QPPV is medically qualified or has access to a medically qualified person.
The QPPV must ensure their pharmacovigilance system is working correctly, which includes the preparation and submission of expedited and Periodic Safety Update Reports to guarantee the highest standard of public safety is maintained.
Other underlying activities which the QPPV must oversee include signal detection, quality assurance, operation of the database, standard operating procedures, maintaining and reviewing contract agreements, assessing training needs and preparing for audits. They are also responsible for providing the authorities with any other information regarding the risk/benefits of the products.
The QPPV must be registered with the competent authorities and include specific personnel details in the Marketing Authorisation Application i.e. a CV and job description. When the new pharmacovigilance legislation comes into effect in 2012 the requirements will change; the details of the system will be maintained in-house in a pharmacovigilance system master file and a confirmation of access to a QPPV will be stated in the Marketing Authorisation Application.
It is important to inform the authorities when a QPPV changes within the organisation. The most appropriate way to guarantee these notifications are reported is to create a standard operating procedure or work instruction which can be followed systematically when changes are implemented. It is vital that the QPPV is available as a central point of contact to the competent authorities on a 24 hour basis and that an equally qualified and experienced deputy QPPV is appointed who can be contacted in their absence.
The role of QPPV and/or the deputy can be outsourced, however this must form part of a formal agreement which will have clear definitions of the responsibilities of each party. In commercial agreements where the company is working with a partner, the party which retains the Marketing Authorisation has the responsibility to ensure the QPPV is in place. The contract needs to be very clear on what the responsibilities of the QPPV are and the expectations of the Marketing Authorisation holder in terms of sharing of information, allocation of appropriate resources and access to senior management to make sure recommendations are carried forward.
Current legislation states that the QPPV must reside in the European Economic Area. New legislation due to be implemented in 2012 states the QPPV must both reside and operate within the EEA. Employing a local QPPV is a requirement in some countries but this can vary depending on the route of the authorisation, for example, in some countries a local QPPV is needed for nationally approved products but not for centrally approved products.
During pharmacovigilance inspections the QPPV will have dedicated sessions with the pharmacovigilance inspector, including one-to-one interviews. The inspectors will be investigating how the QPPV carries out the role, for example how do they know that the standard operating procedures are in place? How are expedited reports sent out in a timely manner? How are training needs identified and met? During inspections a QPPV must demonstrate to the inspector where they fit within the organisation and show clear lines of communication. The inspector may ask for documented evidence of changes the QPPV has made and the steps leading to those changes.
A QPPV has a central role focused on ensuring the company is meeting all of its pharmacovigilance responsibilities and that ultimately the safety of the public using the medicine is maximised. Choosing the right QPPV, whether as an employee for your organisation or a contracted partner is vital in helping your company reach its pharmacovigilance objectives.
By Marisa Stidston-Broadbent – marketing manager at Wainwright Associates Ltd
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