QPPV, tasks and responsibilities
The role and responsibilities of the Pharmacovigilance Qualified Person (QPPV) are established by the Italian and European regulations, in particular Directive 2010/84/EU, EU Regulation no. 520/2012 and by Decree 30 April 2015 (article 17). According to these regulations, the presence of the QPPV is necessary and mandatory: MA holders of products marketed in the European market should have a QPPV, whose presence should be ensured permanently and continuously.
The QPPV is in fact responsible of any pharmacovigilance activities regarding the medicinal products held in the European Union. This task involves three main spheres of responsibility: setting up an appropriate pharmacovigilance system; a knowledge of the safety profile of the medicinal products and a function of contact point between the company and competent authorities.
In order to perform the task and take on the responsibilities provided for by the regulations, the QPPV should have theoretical and practical knowledge and have documented experience in the field of pharmacovigilance. It is preferable that this is a figure with medical training, however this is not a requirement, as also specified by the regulations: in case of no basic medical training, it will be sufficient that the QPPV is assisted by a medically trained person.
Another requirement specified in the regulation is that the QPPV is located and operates in the European Union, and that his/her tasks are defined in specific lists and organisational flows charts. The information regarding the QPPV shall also be include in the company pharmacovigilance system (PSMF).
Let’s see more in details which are the QPPV responsibilities
The guideline on Good Pharmacovigilance Practices (GVP) provides for that, as responsible of the pharmacovigilance system, the QPPV should be aware of any conditions and obligations deriving from the MA release and of any commitment taken on by the MA holder to ensure the product safety. The QPPV should also know all the measures taken for the risk minimisation, the content of the Risk Management Plan (RMP), and any post-authorisation studies carried out in accordance with the requirements of the RMP. This applies in particular for post-authorisation safety studies (PASS).
The QPPV is also responsible of the performance of all pharmacovigilance activities, with special reference to the submission of documents that should be drafted based on the standards required by the relevant regulations. The QPPV will ensure that all pharmacovigilance information and data submitted to Member States authorities and to the European Medicine Agency (EMA) are correct and complete, promptly and exhaustively responding to any request received from the authorities, especially if related to the review of the risk-benefit profile of an authorised product. In response to the request of the competent authorities, the QPPV will draft and provide communications to patients and health professionals, as well as safety restrictions and MA variations, when requested.
Considering how delicate this role is, it is essential that the QPPV receives from the MA holder an initial and continuous training and that is available on a 24 h basis to promptly face any request from the competent authorities in case of specific requests that could have an impact on public health. The MA holder shall in turn notify the name and contact details of the QPPV to the European Agency and to competent national agencies, and will ensure that this has the required qualification and authority for the management of the quality system and pharmacovigilance activities.
All the responsibilities of the person appointed as QPPV should reflect the information and requirements reported in the GVP guideline Module I and are detailed in a job description. This document also specifies the tasks of the QPPV: PSUR and RMP drafting and submission; signal detection activity management; quality system monitoring; drafting, review and approval of the PSMF; pharmacovigilance personnel training; preparation of inspections and audits; safety information management.
Considering the variety of the tasks and the huge amount of responsibilities of the QPPV, it is not rare that MA holders outsource this role. Entrusting agencies specialised in pharmacovigilance outsourcing with QPPV activities can save time and resources, ensuring at the same time a compliance with all the provisions on post-marketing drug safety.
Written by: Maria Pia Felici
