Why is it Advantageous to outsource QPPV to Navitas Life Sciences?

All about QPPV with Dr Philipp Hofmann, Head of Pharmacovigilance, QPPV, Navitas Life Sciences

A Market Authorization Holder (MAH) appoints a Qualified Person responsible for Pharmacovigilance (QPPV) to market drug products in the European Union (EU) and the European Economic Area (EEA). It is a regulatory requirement, and the expert must reside within the EU or EEA region. QPPV requirements are provided by the EU regulations Medicinal Product Directive (MPD) (Directive 2001/83/EC (Article 104) as well as the Regulation (EC) No 726/2004 (Article 23))

The role of the QPPV ensures that all legal obligations of the MAH are met in terms of the monitoring of the drug product in the market, with respect to pharmacovigilance.

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All companies on the European market, whatever small or large pharmaceuticals, especially those with their headquarters outside of the EU, require cost efficient and expert PV support as well as person located in the European Union. This helps in the efficient management and expert handling of PV activities.

Navitas Life Sciences Drives Efficient Pharmacovigilance Systems

The presence of an expert QPPV who has the necessary knowledge, expertise, foresight, and leadership aids in managing efficient PV systems. This allows pharma companies, or the MAH, to focus on their core strengths like identification of new compounds.

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Navitas Life Sciences Drives Efficient Pharmacovigilance Systems

Expand your Source of Insight with Navitas Life Sciences

With a deep understanding of the PV system and the need for rigorous assessment based on regulations, our Head of Pharmacovigilance and QPPV, Philipp Hofmann, has taken time to share his valuable insights about the role of the QPPV.

Tell us a bit about your professional background?

I studied Medicine at the University of Marburg, Germany, after which I started my career as a medical writer in the pharmaceutical industry, responsible of Annual Safety Reports. My first position was soon followed by a continuous professional development, starting from Medical Manager Vigilance, Safety Officer, Deputy EU QPPV, Director Global Safety to Head of Pharmacovigilance, and EU QPPV prior to joining Navitas Life Sciences. With my specialization in Pharmaceutical Medicine, I am Head of Pharmacovigilance at Navitas Life Sciences and I am responsible for the QPPV office and our service offering.

Dr Philipp Hofmann, MD

Head Pharmacovigilance, QPPV,
Navitas Life Sciences

What is a QPPV? Can you give us an insight into your work?

The QPPV is the Qualified person for pharmacovigilance (not to be confused with the Qualified person for batch release). Every company with a market authoritization in the EU needs to have a QPPV available on 24/7 basis for the European Agency (EMA). The QPPV needs to maintain an oversight on all PV activities of a MAH, which includes quality, single cases, aggregate reports, and many other aspects.

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Can you give us a glimpse of the QPPV office?

The QPPV office was established at Navitas Life Sciences 4 years ago. The QPPV covers the legal PV obligations within the European Economic Area.

Today I would like to give you a glimpse on the daily work of a QPPV. Together with my deputy QPPV, one of our tasks is the review of documents, which are provided by our clients or produced internally. These typically involve Risk Management Plans and Signal reports, both of which require a thorough QPPV review before they can be finalized, approved and, if applicable, be provided to the relevant Health Authority. This review takes several hours and includes a check on numerous details including marketing figures, medical and pharmaceutical aspects, consistency of listings, as well as checking if the final summary matches with reality. This is a time-consuming, but necessary process, as I finally approve the document with my legal signature.

Another aspect of QPPV work involves auditing and inspection readiness. Members of the QPPV office perform audits of external partners, as part of the vendor qualification process. This is done in close co-operation with our certified auditors from our in-house Quality Assurance team. This process is required when we would like to outsource a process like translation or local QPPV work. On the other hand, the QPPV office is audited regularly by our internal QA team to ensure compliance with both legal requirements and Standard Operating Procedures (SOPs). This helps a lot with reference to inspection readiness. Health Authorities regularly perform inspections for pharmaceutical companies. As the QPPV plays a major role in the European PV system, usually they have a very active role during an inspection.

Which countries do our QPPV services relate to?

The QPPV is responsible for the European Economic Area (EEA), i.e. the EU and, in addition, Iceland, Liechtenstein, and Norway.

What is the significance of signal detection in pharmacovigilance, and what is Navitas Life Sciences’ expertise in it?

Our experts in signal detection provide “Signal as a Service” for pharmaceutical companies. We offer the full service of signal detection by our team of PV and medical experts. This starts from signal detection, validation, analysis, and prioritization, before concluding with a signal assessment.

What is the business model of QPPV offered by Navitas Life Sciences?

Our business model offers two possibilities: smaller MAH can outsource the function of the QPPV as per their needs with only some hours per month and additional hours of QPPV consulting. Larger MAH can outsource depending on their portfolio and their geography, a full QPPV office with a QPPV, deputy QPPV, and administrational support.

When choosing a QPPV partner, it is important to select a partner with access to the best local experts, and who can provide scalable and customized solutions based on specific needs. Navitas Life Sciences provides integrated and end-to-end solutions that extend beyond QPPV and include comprehensive management of safety reporting, lucid communications, and effective support to all stakeholders.

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To find out more about our services and solutions, reach out to us at This email address is being protected from spambots. You need JavaScript enabled to view it.