Marketing authorisation holders (MAHs) carry the responsibility of ensuring the safety and efficacy of their medicinal products, with a significant portion of this duty entrusted to the Qualified Person Responsible for Pharmacovigilance (QPPV). Although this responsibility extends both human and veterinary medicines, and some aspects are similar between them, this blog post will specifically focus on the role of the Veterinary QPPV.
The QPPV plays a key role in maintaining robust pharmacovigilance system across the European Union and ensuring compliance with the requirements of EU Regulation 2019/6. QPPV’s expertise and oversight is vital for company to uphold regulatory standards and maintain trust for the safety of their veterinary medicines.
Regulation (EU) 2019/6 underscores the necessity for robust pharmacovigilance systems. It mandates that each marketing authorisation holder shall appoint a QPPV who is not only qualified in veterinary pharmacovigilance but also possesses a comprehensive understanding of the regulatory landscape.
Regulation aims to enhance the safety of veterinary medicinal products by ensuring that adverse events are promptly identified and managed. The QPPV may not directly handle adverse event reports but must maintain a comprehensive overview of the situation and possess the ability to intervene when necessary.
Implementing Regulation 2021/1281 further details the operational aspects and tasks related to pharmacovigilance and QPPV role, including the responsibility of the QPPV in maintaining a proactive oversight of pharmacovigilance activities. This includes regular audits and risk assessments to ensure compliance with regulatory standards.
Key Responsibilities of the Veterinary QPPV
The QPPV must reside and operate within the EU, facilitating direct communication with European authorities. This ensures that the QPPV can respond swiftly to any pharmacovigilance queries or issues, thereby maintaining the integrity and responsiveness of the pharmacovigilance system.
Veterinary QPPV oversees all pharmacovigilance activities, which include for example:
Monitoring and Reporting of Adverse events (AEs) as well as Signal management
Ensuring that all AEs are recorded and reported to the appropriate authorities in a timely manner. Signal management involves continuous analysis of adverse event data to detect potential safety signals early. The QPPV is responsible for overseeing this process, ensuring that possible emerging risks are identified and reacted promptly.
Document Management and Quality Management System
Implementing a robust quality management system (QMS) for pharmacovigilance that includes also record management and data validation to uphold the integrity of all safety related data. For this, the QPPV must work in close collaboration with the quality assurance (QA) unit.
Embracing advanced software solutions as a transformative tool in pharmacovigilance processes reflects modern practices. However, as these software solutions become increasingly common, the QPPV must ensure that they comply with regulatory standards and operate as intended. This requires thorough evaluation and validation of technology to guarantee that it supports efficient data management and enhances the overall integrity of the pharmacovigilance system.
Communication with other departments and stakeholders
Facilitating fluent communication between stakeholders, ensuring that all parties are informed and engaged in the pharmacovigilance processes. Internal communication between other in-house departments (e.g. research and development, marketing, legal), is also important, to ensure that pharmacovigilance system is comprehensively followed in all units.
Crisis management
Developing and executing strategies to effectively manage unexpected pharmacovigilance crises, including emerging safety issues or potentially important environmental issues. This involves rapid response protocols, clear communication channels, and collaboration with relevant departments to mitigate risks and maintain compliance.
Medfiles’ Veterinary QPPV Services
At Medfiles, our QPPV services are tailored to meet the specific needs outlined in Regulation 2019/6 and VGVP modules. Our team of QPPVs are equipped with training in quality assurance, data integrity, and pharmacovigilance processes, ensuring that your processes related to veterinary pharmacovigilance meet all the standards. This also ensures that your veterinary medicinal products are monitored effectively for safety and compliance.
By outsourcing your pharmacovigilance activities to Medfiles, you can benefit from:
- Expert Oversight: Our QPPVs provide proactive oversight of pharmacovigilance processes, ensuring compliance with regulatory requirements and the safety of your veterinary products.
- PV System Setup and Maintenance: Whether you need assistance with the setup and maintenance of your entire pharmacovigilance system or specific activities, Medfiles offers solutions tailored to your needs.
- Enhanced Communication: We facilitate effective communication between stakeholders, ensuring that all parties are aligned and informed about pharmacovigilance activities.
The QPPV is vital for ensuring the safety and compliance of veterinary medicinal products within the EU. In an ever-evolving regulatory landscape, the role of the veterinary QPPV is even more crucial. MAHs depend on the QPPV to meet the demands of EU Regulation 2019/6, which requires a comprehensive pharmacovigilance system.
By partnering with Medfiles, you can rest assured that your veterinary products are in safe hands, allowing you to focus on delivering quality care to your clients and their animals.
Free WEBINAR: EU Veterinary Medicinal Products Regulation from the perspective of variations and the quality part of the pharmacovigilance system
In our webinar you will learn about the main changes and requirements brought about by the Veterinary Medicinal Products Regulation. In the webinar we will discuss variation management and the relationship between pharmacovigilance systems and the related quality measures.
See also
- How veterinary adverse event cases are managed in the EU/EEA and UK
- What to know about veterinary signal management
- Meet our people: EU QPPV ensures drug safety across Europe
- Best practices for maintaining a veterinary pharmacovigilance quality system
- Meet Medfiles’ dedicated animal health team – experts in CMC, regulatory affairs, pharmacovigilance and animal feed
Author: Saana Lamminjoki, M.Sc., Safety Manager
Saana Lamminjoki joined Medfiles Pharmacovigilance team in May 2021 and since then has been working with both human and veterinary PV activities in the EU and UK.
Currently Saana is responsible for operational leading of veterinary pharmacovigilance activities. Her day-to-day responsibilities for veterinary products include, for example, monitoring of published scientific literature, signal detection and management, risk management and evaluation and processing of adverse event reports from the EU, UK and third countries. Saana is actively involved in the maintenance of the Pharmacovigilance System Master File (PSMF) and the Quality Management System, ensuring that all veterinary SOPs and processes are compliant. She has also contributed to the set-up of the veterinary PV system.
With a bachelor’s degree in pharmacy and a master’s degree in general toxicology, Saana brings her knowledge and expertise to her role.
