QPPV? What is that?

Well, it is another European particularity.

Role:

The QPPV or Qualified Person Responsible for Pharmacovigilance is a person appointed by a Marketing Authorization Holder (MAH) to establish and maintain its pharmacovigilance system. He or she is personally responsible for overseeing all its relevant aspects.

He is the 24/7 contact person of the local Health Authorities and European Medicines Agency (EMA).

According to the Module I of the Good Pharmacovigilance Practices, the QPPV’s additional responsibilities should include:

· “having an overview of medicinal product safety profiles and any emerging safety concerns;

· having awareness of any conditions or obligations adopted as part of the marketing authorizations and other commitments relating to safety or the safe use of the products;

· having awareness of risk minimization measures;

· being aware of and having sufficient authority over the content of risk management plans;

· being involved in the review and sign-off of protocols of post-authorization safety studies conducted in the EU or pursuant to a risk management plan agreed in the EU;

· having awareness of post-authorization safety studies requested by a competent authority including the results of such studies;

· ensuring conduct of pharmacovigilance and submission of all pharmacovigilance-related documents in accordance with the legal requirements and GVP;

· ensuring the necessary quality, including the correctness and completeness, of pharmacovigilance data submitted to the competent authorities in Members States and the Agency;

· ensuring a full and prompt response to any request from the competent authorities in Members States and from the Agency for the provision of additional information necessary for the benefit- risk evaluation of a medicinal product;

· providing any other information relevant to the benefit-risk evaluation to the competent authorities in Members States and the Agency;

· providing input into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals); “

Qualifications:

In terms of qualifications, the QPPV should be proficient in managing PV systems and an expert in some medical areas (medicine, pharmaceutical sciences, epidemiology and biostatistics). In case the QPPV does not have that knowledge, he should be assisted by a medically trained person.

Geographical constraints: he or she has to reside and work in the European Union (EU) or European Economic Area (EEA).

References:

Directive 2010/84/EU: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0074:0099:EN:PDF

Good Pharmacovigilance Practices, Module I – Pharmacovigilance systems and their quality systems: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129132.pdf