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, ProPharma 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, ProPharma 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, ProPharma 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.
Europe
Across the European region, the presence and role of an LPPV are dictated by harmonized and country-specific regulations, underscoring a strong focus on pharmacovigilance and patient safety.
Webinar Replay: How to Setup an Effective PV System in the UK and EU/EEA
Watch or re-watch our "QPPV Office: Ensuring Compliance and Safety in Pharmacovigilance" webinar. This session was packed with valuable information on the roles and responsibilities of the Qualified Person for Pharmacovigilance (QPPV), best practices for maintaining compliance, and strategies for ensuring drug safety.
QPPV & LPPV Articles
The QPPV: An Essential Guide to the Qualified Person Responsible for Pharmacovigilance
When submitting marketing authorisation applications (MAAs) in Europe, the applicant (Marketing Authorization Holder, MAH) shall already have set up a pharmacovigilance system. A Summary of the...
The LPPV Network: An Essential Guide to Local Person Responsible for Pharmacovigilance
Every marketing authorization holder (MAH) needs a pharmacovigilance system to guarantee the safety of its products.
The GPO An Essential Guide to the Graduated Plan Officer (Der Stufenplanbeauftragte)
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