QPPV services.
What is a Qualified Person for Pharmacovigilance (QPPV)?
The QPPV role is required within the European Union (EU) or wider European Economic Area (EEA), and provides evidence for Marketing Authorization Applicants (MAAs) and Marketing Authorization Holders (MAHs) and that they are meeting the mandatory level of permanent and continuous human pharmacovigilance required by EU law.
It follows the EU regulations Medicinal Product Directive (MPD) (Directive 2001/83/EC (Article 104) and Regulation (EC) No 726/2004 (Article 23))
A QPPV is responsible for the establishment and management/maintenance of a MAH’s pharmacovigilance system and as such plays a significant part in the underlying quality system, product safety issues and all other pharmacovigilance and safety activities .
QPPVs are also personally legally responsible for the safety of an MAH’s products, and must be registered in the EU’s EudraVigilance database.
Other key QPPV activities include:
- Acting as the single point of contact and provide safety or any other benefit-risk evaluation responses to EU national Competent Authorities, or the EMA, on a 24/7 basis.
- Ensure that the Pharmacovigilance System Master File (PSMF) is constantly up-to-date and correctly describes the current pharmacovigilance system.
- Overseeing the safety profiles of marketed products and any emerging safety concerns;
- Ensure that the level of all pharmacovigilance activities, and the submission of all pharmacovigilance-related documents, is in accordance with GVP practices and all other applicable legal requirements.
- Act as a contact point for any PV audits or inspections.
- Maintenance of detailed records for any suspected adverse reactions to products.
- The drafting and submission of Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) to national Competent Authorities and/or the EMA
Why outsource to Arriello’s QPPV service?
We provide an excellent and efficient level of communication between all stakeholders, operating within a robust, lean and straightforward Quality Management System, overseen by a fully experienced QPPV.
We can create and maintain your core and local PSMFs, ensuring your PV system remains fully compliant with EU and International regulations and guidelines, and that it is inspection-ready at all times.
QPPV outsourcing is especially efficient for MAAs where an in-house QPPV is not present as it can mitigate the resource risk if your product fails to obtain approval for any reason.
Whether it is a new PV system implementation or a PV system transfer from an in-house PV department or a previous PV provider, our experienced team will guide you through the implementation of all your required PV activities and QPPV requirements.
We can also support you with Local Person for Pharmacovigilance (LPPV) and Local Safety Officer (LSO) services at the country level depending on applicable regulations.
Pharmacovigilance System Transfer. A practical two-part guide.
“Throwing good money after bad is never a good idea, yet all too often, pharma companies persevere with poor or inadequate PV information capture and reporting capabilities because the alternative – moving to a new provider – is seen as too great an upheaval and potentially too much risk.”
In this practical two-part guide, Cláudia Serafim, PV Manager & EU QPPV at Arriello, dispels the common myths around PV system transfer, sets out the benefits of making the change sooner rather than later, and provides a 13-part action plan to make the transition easy, and successful.
Selected PV Case Studies.
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What our clients say about us.
Working with the Arriello Clinical Safety Team has resulted in flawless forethought, planning and execution. Their global regulatory expertise, coupled with their quality acumen, sets a standard for which other PV service providers should aspire. Nothing has fallen through the cracks and I can sleep at night knowing we are not only operationally prepared, but inspection-ready – a comfort for which I would happily pay multiples.
You already had in place all the SOPs and processes needed for a PV system, but in our case, you were always open to work with parts of our system (some of our internal SOPs...) including some really special Cinfa requirements.
My experience with Arriello was an overwhelmingly positive one. Very professional, accommodating and readily able to adapt to our needs even as they changed.
As we have expanded services the business development team has been prompt and understanding of our needs and worked diligently to ensure flexible pricing models that fit our unique structure and budget. The project team is always eager to add on a new service and understand our requests, providing a seamless transition and effective set-up.