Qualified Person for Pharmacovigilance (QPPV)

QPPV Office

Appointing an experienced Qualified Person for Pharmacovigilance (QPPV), Local Person for Pharmacovigilance (LPPV), and deputy QPPV/LPPV can require considerable time and resources.

Although the requirements and responsibilities of a QPPV are specified in EU and UK legislation, LPPVs are subject to their own national legislation (e.g., the Graduated Plan Officer "Stufenplanbeauftragter" for Germany), which can also be daunting. As a global pharmacovigilance provider, Radiofilum Pharmaceutical can advise you on the varied requirements for QPPVs and LPPVs to determine the services that will accommodate your business needs and ensure compliance with the pharmacovigilance legislation unique to each location. This will help you to determine your product launch strategy.

Based upon such strategy, Radiofilum Pharmaceutical can provide you with appropriately qualified and experienced QPPVs, LPPVs, and deputies globally. We have a world-wide network of QPPVs and LPPVs to serve you with their expertise from Europe to Australia and in 100 countries.

Role of the EU QPPV

Every Marketing Authorization Holder (MAH) in Europe has an obligation to establish a pharmacovigilance (PV) system for the fulfillment of PV tasks for its products. When setting up a PV system in Europe, the MAH must appoint an EU QPPV to establish and maintain the MAH’s PV system. In addition to the establishment and oversight of the PV system, the QPPV also has several legislative responsibilities.

Responsibilities of the EU QPPV include:

• Establish and maintain the MAH’s PV system
• Monitor the safety of the MAH’s drug products
• Coordinate actions to stay compliant with local legislation
• Serve as the 24/7 point of contact for Competent Authorities

Role of an LPPV

In addition, many European and other countries legally require a Local Person for Pharmacovigilance (LPPV) at a country level who may report to the EU QPPV (e.g., for Germany a Graduated Plan Officer (GPO) or Stufenplanbeauftragter is required). Although the requirements and responsibilities of an EU QPPV are specified in EU legislation, LPPVs are subject to their own national legislation.

Some QPPVs may have their own network of LPPVs to help fulfill local requirements. As a global pharmacovigilance provider, Radiofilum Pharmaceutical can advise you about the various important requirements for EU QPPVs and LPPVs, to ensure you have the right resources in place to fully comply with the regulations for your PV system in Europe.