QPPV Services

Why do you need QPPV role in a pharmacovigilance system?

The pharmacovigilance market is fast-growing and it is a challenge to find reliable and experienced service companies in the field. As DeltaPV, we consider that efficient communication is needed to explain needs in a pharmacovigilance system. The EU Qualified Person for Pharmacovigilance (EU-QPPV) who will oversee the Pharmacovigilance functions of the Marketing Authorization Holder is critical when setting up a PV system in Europe. Additionally, many European and other countries also legally require a Local Person for Pharmacovigilance (LPPV) at a country level. LPPVs are subject to their own national legislation and Our LPPVs can provide general pharmacovigilance consultancy based on local pharmacovigilance requirements. Recruiting of Local QPPV inside Marketing Authorization Holder can consume a great deal of your time, budget, and r esources. DeltaPV service for QPPV, allows for greater success with preserving your effort to deal with such a complex process. Beyond the EU and UK QPPV roles, outsourcing Local QPPV or LPPV to us will ensure that the PV system will have highest quality and become well synchronized. DeltaPV can support you with EU QPPV, UK QPPV and LPPV services for different countries. DeltaPV does not only offer support in understanding which countries require a local representative but also provides a network of local representatives in these individual countries to meet any specific local pharmacovigilance requirements.


Appointing a European Union Qualified Person for Pharmacovigilance (EU-QPPV) who will be responsible of overseeing the Pharmacovigilance functions of the Marketing Authorization Holder is mandatory when setting up a PV system in Europe. Additionally, numerous European and Non-European countries also mandates appointment of a Local Person for Pharmacovigilance (LPPV) at a country level. LPPVs are subject to their own national legislation. Employing a Local QPPV or an LPPV within the company costs Marketing Authorization Holders a great deal of resources, and since the pharmacovigilance market is a rapidly growing market in which trustworthy and expert support is scarce, it also requires a great deal of time and effort. DeltaPV’s expertise in the field will allow you to navigate through such a complex process with much more ease and peace of mind. We can support you with EU QPPV, UK QPPV and LPPV appointment services in various European and Non-European countries.

References
European Medicines Agency. 22 June 2012 EMA/541760/2011. Guideline on good pharmacovigilance practices (GVP) Module I – Pharmacovigilance systems and their quality systems.


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