,Qualified Person for Pharmacovigilance (QPPV) Services - Overview
Marketing Authorization Holder (MAH) of medicinal products authorized for marketing in the European Economic Area (EEA) have a crucial legal responsibility to establish a robust PV system. Central to this obligation is the appointment of a Qualified Person for Pharmacovigilance (QPPV) and, in some cases, a Local Responsible Person (LRP) or Local Person Responsible for Pharmacovigilance (LPPV).
Qualified Person for Pharmacovigilance (QPPV)
The QPPV serves as the cornerstone of an MAH’s Pharmacovigilance system in the EU. Their responsibilities encompass a wide range of critical tasks, including:
- Establishment and maintenance of the MAH’s PV system
- 24/7 availability as the single point of contact for Regulatory authorities on PV related matters
- Monitoring product safety and emerging safety concerns
- Oversight of the PV system's functioning and quality
The Qualified Person for Pharmacovigilance (QPPV) must reside and operate within a member state of the EEA. Freyr currently boasts of having an in-house QPPV based in Germany, with a Deputy QPPV stationed in Romania, ensuring robust QPPV coverage across the region.
Local Responsible Person (LRP) and Local QPPV for Pharmacovigilance
In addition to the QPPV, certain EEA countries may require the appointment of a Local Responsible Person (LRP) or Local QPPV for Pharmacovigilance, especially in the context of the UK post-Brexit. LRPs/LPPVs are tasked with specific local-level responsibilities, including:
- Collecting, Processing, and Submitting Individual Case Safety Reports (ICSR) at the national level
- Local submissions of other PV documents
- Implementation of additional Risk Minimization Measures (aRMM)
- Acting as a liaison between the MAH and local Regulatory authorities
LRPs must usually be resident of the country where their services are required and possess fluency in the local language. Freyr, leveraging its extensive affiliate network, provides Local Person for Pharmacovigilance (LPPV) support for most EU countries, ensuring compliance with local PV requirements.
Qualified Person for Pharmacovigilance (QPPV) Services
Freyr specializes in delivering top-notch PV and QPPV services, including:
- QPPV support: From establishing PV systems to ensuring regulatory compliance, Freyr’s Qualified Person for Pharmacovigilance (QPPV) Services are designed to meet the highest standards of quality and reliability.
- LRP/LPPV support: Our team of experts assists clients in appointing LRPs/LPPVs and navigating the complex landscape of local PV requirements, guaranteeing adherence to all relevant regulations.
Training and consulting: Freyr offers comprehensive programs and consulting services to empower clients with the knowledge and tools necessary for effective PV management.
Freyr offers a comprehensive suite of Qualified Person for Pharmacovigilance (QPPV) Services tailored to meet the diverse needs of MAHs operating in the pharmaceutical industry. Our advantages include:
- Years of experience in PV, backed by a team of seasoned professionals well-versed in global PV regulations and best practices.
- An extensive affiliate network spanning the globe, enabling us to provide tailored QPPV services, LPPV, and LRP solutions not only within the EU but also in regions outside the EEA.
- A strong focus on compliance, ensuring that our clients meet their PV obligations seamlessly while mitigating risks effectively.
