When deciding on a QPPV partner, it's crucial to opt for one with access to top-tier local specialists and the ability to offer adaptable, tailor-made solutions for precise requirements. Navitas Life Sciences delivers comprehensive and seamless solutions encompassing QPPV responsibilities and extending to comprehensive safety reporting management, clear communication, and efficient support for all stakeholders. In this blog we highlight some of the important FAQs on QPPV, like QPPV roles and responsibilities, and QPPV requirements. Find out what QPPV entails.
What is a QPPV?/ Who is a QPPV?
A Qualified Person for Pharmacovigilance (QPPV) is personally responsible, by law, for the safety of the human pharmaceutical products marketed by that company in the EU. The QPPV should reside in the EU and provide support across the globe through in-house QPPVs and a network of Local QPPVs.
What is PSMF reporting?
The Pharmacovigilance System Master File (PSMF) serves as an intricate documentation outlining the pharmacovigilance system employed by the Marketing Authorization Holder (MAH) concerning one or multiple authorized medicinal products.
It's important to note that the PSMF stands distinct from the marketing authorization (MA) dossier and is upheld autonomously from the MA. Accessibility to the PSMF should be continuous for inspection purposes and must be promptly furnished to Competent Authorities within a 7-day timeframe upon request.
What is an ICSR?
The Individual Case Safety Report (ICSR) is designed to gather essential information required for reporting adverse events, product issues, and consumer grievances linked to the utilization of FDA-regulated products.
In the realm of pharmacovigilance (PV), the role of a Qualified Person for Pharmacovigilance (QPPV) stands as a cornerstone in ensuring the safety of pharmaceutical products. At Navitas Life Sciences, we recognize the criticality of the QPPV role and offer comprehensive solutions to meet both global and local QPPV needs.
What are QPPV Role and Responsibilities?
A QPPV holds a pivotal position, mandated by law, responsible for overseeing the safety of pharmaceutical products marketed in the EU. Their responsibilities encompass a wide array of tasks, including maintaining and establishing PV systems, monitoring product safety, ensuring compliance with local legislations, acting as the primary liaison with Competent Authorities, and managing audits and inspections.
Special Guidance for QPPV Requirements in the UK
- Qualified Person for Pharmacovigilance (QPPV) roles and responsibilities for products licensed in the UK are aligned with those of the EU/EEA QPPV.
- According to regulation 182 of the Human Medicines Regulations 2012 (as amended), the QPPV must possess suitable qualifications and be resident and operational in either the EU or the UK. The UK QPPV is accountable for establishing and maintaining the pharmacovigilance system for products authorized in the UK.
- Effective from January 1, 2021, there will be no temporary exemption from the requirement to have a QPPV who resides and operates in the EU or the UK and oversees the pharmacovigilance system for UK authorized products.
- For marketing authorizations (MAs) that encompass the entire UK or are specific to Northern Ireland, the legal prerequisites regarding the qualifications and duties of the QPPV outlined in Article 10 of the Commission Implementing Regulation (EU) No 520/2012 (CIR) will remain unchanged.
- For MAs specific to Great Britain, the legal requirements regarding the qualifications and responsibilities of the QPPV are delineated in paragraph 10 of HMR Schedule 12A (inserted by the EU Exit Regulations 2019), which mirrors Article 10 of CIR.
Why Choose Navitas Life Sciences for QPPV Services?
- Access to Expertise: Our network comprises experienced EU and local QPPVs, ensuring that clients have access to the best local experts who understand the nuances of regional regulations.
- Tailored Solutions: We offer scalable and customized solutions tailored to meet specific PV requirements, providing flexibility and adaptability to changing needs.
- Comprehensive Support: Beyond QPPV services, we provide end-to-end solutions encompassing safety reporting, transparent communications, and support for all stakeholders involved.
Outsourcing Your QPPV Role to Navitas Life Sciences
By outsourcing the QPPV role to Navitas Life Sciences, clients benefit from:
- Optimal Expertise and Infrastructure: We possess the right expertise coupled with state-of-the-art infrastructure to ensure efficient and effective QPPV support.
- Global Reach: With a global network of QPPVs, we offer support across various regions, facilitating seamless compliance with local PV requirements.
- Cost-Effectivene: Our outsourcing solutions are designed to offer cost-effective alternatives to in-house QPPV arrangements, helping clients optimize their PV operations.
- Scalability: Our services are scalable, allowing clients to adjust resources based on evolving pharmacovigilance needs, thereby ensuring flexibility and efficiency.
At Navitas Life Sciences, we understand the critical role of the QPPV and are committed to providing unparalleled support to our clients in navigating complex PV landscapes. Whether you are seeking a global QPPV partner or require assistance with local PV requirements, Navitas Life Sciences stands ready to be your trusted ally in ensuring pharmacovigilance excellence.
To know more about our services and solutions, reach out to us at