The Importance of the Qualified Person of Pharmacovigilance (QPPV)
The Importance of the Australian Qualified Person of Pharmacovigilance (QPPVA) and the European Qualified Person of Pharmacovigilance (EU-QPPV).
In the dynamic and ever-expanding realm of the global pharmaceutical industry, ensuring the safety and effectiveness of medicinal products is paramount. Regulatory bodies worldwide have become more rigorous, implementing strict guidelines and requirements to carefully oversee and handle negative reactions to drugs. Two pivotal figures in this relentless pursuit of pharmaceutical safety are the Australian Qualified Person of Pharmacovigilance (QPPVA) and the European Qualified Person of Pharmacovigilance (EU-QPPV). Join us as we unravel the vital roles and responsibilities these experts play, safeguarding lives in an increasingly complex landscape of medicine.
Defining the Roles:
The Australian Qualified Person of Pharmacovigilance (QPPVA):
In Australia, the Therapeutic Goods Administration (TGA) oversees pharmacovigilance activities. Sponsors (i.e., Local Marketing Authorisation Holders) of medicines included on the Australian Register of Therapeutic Goods (ARTG) must have a pharmacovigilance system that meets specific requirements. One of the requirements is to have a designated Qualified Person responsible for overseeing the pharmacovigilance system within the organization. They must ensure regulatory compliance and the effectiveness of the sponsor’s pharmacovigilance system.
The European Qualified Person of Pharmacovigilance (EU QPPV):
The European Medicines Agency (EMA) is the European Union (EU) regulatory authority. The EU QPPV is mandated by the EMA and is responsible for maintaining a comprehensive pharmacovigilance system across all EU member states. These trained individuals assist in communicating with regulatory authorities and member states.
Regulatory Compliance:
The Australian and European QPPVs are crucial in ensuring compliance with regional regulatory requirements.
Australian QPPV:
The Australian QPPV ensures that a company’s pharmacovigilance system aligns with the guidelines set forth by the TGA. They oversee the collection, assessment, and reporting of adverse events, ensuring that safety concerns are appropriately addressed and communicated to the TGA.
EU QPPV:
The EU QPPV is responsible for implementing and maintaining the pharmacovigilance system throughout the EU member states, in line with the guidelines of the EMA. Their responsibilities involve overseeing the collection, evaluation, and reporting of adverse reactions, ensuring strict compliance with the EU Pharmacovigilance and Good Pharmacovigilance Practices (GVP) regulations.
Communication:
Both roles emphasize the importance of timely and accurate reporting of adverse events.
Australian QPPV:
The Australian QPPV is responsible for ensuring effective systems are in place for submitting individual case safety reports (ICSRs) to the TGA within specific timelines. They are vital in ensuring effective communication between the company and the regulatory authority regarding drug safety concerns. Though they do not act as a contact person, their role is paramount in providing medical support, audits, and inspections.
EU QPPV:
The EU QPPV, in some instances, is responsible for drafting and providing communications to patients and health professionals, as well as safety restrictions and Marketing Authorisation variations. The QPPV must act as the Marketing Authorisation Holder’s contact point for pharmacovigilance inspections. In most instances, any safety correspondence with any National Competent Authority will
include the EU QPPV. This may consist of safety-relevant Good Manufacturing Practice (GMP) concerns.
Regional Differences and Collaboration:
While both roles serve similar objectives, there are notable differences and opportunities for collaboration between the Australian and European QPPVs.
Regional Differences:
One significant difference lies in the regulatory frameworks and processes. The Australian pharmacovigilance system operates under the guidelines and regulations set by the TGA. In contrast, the European system adheres to the regulations established by the EMA and the EU member states. These variations include reporting requirements and regulatory procedures. However, there are many similarities in the operational requirements for Sponsors (i.e., Marketing Authority Holders) as the TGA has adopted many parts of the EU GVP guidelines.
Collaboration Opportunities:
Despite the regional disparities and the distant ocean that separates the regions, the collaboration between Australian and European QPPVs can be beneficial and rewarding. Sharing best practices, exchanging information, and harmonizing approaches to pharmacovigilance can enhance the overall global drug safety landscape. Collaboration may involve working together to facilitate effective and timely Pharmacovigilance Systems changes.
Professional Competence and Qualifications:
The Australian and European QPPVs require individuals with a high level of competence and expertise.
Australian QPPV:
The ideal Australian Qualified Person of Pharmacovigilance (QPPVA) is extensively trained and experienced in pharmacovigilance practices and relevant legislation in Australia. While medical qualification is preferred, access to a medically qualified person is essential for clinical assessments when necessary. It is recommended that the medically qualified person resides and holds medical registration in Australia to address adverse reactions and Significant Safety Issues (SSI) and evaluate the benefit-risk balance of medicines in the Australian context. These recommendations aim to ensure the QPPVA possesses the necessary qualifications and experience to monitor the safety of medicines effectively. The specific characteristics and skills required for the QPPVA should align with their designated roles and responsibilities, enabling compliance with pharmacovigilance requirements. Moreover, a comprehensive understanding of Australian and global pharmacovigilance processes is essential for effectively overseeing the entire pharmacovigilance system.
EU QPPV:
The European Medicines Agency (EMA) outlines specific criteria for the person serving as the Qualified Person for Pharmacovigilance (QPPV). According to the EMA, the QPPV must possess appropriate qualifications and expertise in pharmacovigilance theory and practice. They should have comprehensive experience across all areas of pharmacovigilance and must be a resident and active worker within the European Union (EU)/European Economic Area (EEA). The QPPV, as well as their deputy, must be registered with the EMA. The QPPV or their deputy must be available 24/7 to address pharmacovigilance issues and serve as a single point of contact for such matters. Additionally, they should be prepared for pharmacovigilance inspections as regulatory authorities require.
Conclusion
The roles of the Australian Qualified Person of Pharmacovigilance (QPPV) and the European Qualified Person of Pharmacovigilance (EU QPPV) are critical in ensuring the safety of pharmaceutical products. While there are some differences in regional regulations and reporting requirements, both roles share the common goal of safeguarding public health through effective pharmacovigilance systems.
The Australian QPPV focuses on compliance with the guidelines set by the TGA. In contrast, the EU QPPV oversees the pharmacovigilance system across EU member states following the EMA’s regulations. By fulfilling their responsibilities, both QPPVs contribute to improving drug safety, timely reporting of adverse events, and effective communication with regulatory authorities.
Collaboration between the Australian and European QPPVs can enhance global pharmacovigilance efforts, allowing for knowledge-sharing and harmonizing practices. Overall, these roles play a crucial part in maintaining public confidence in the safety and efficacy of pharmaceutical products, ultimately benefiting patients worldwide.
Please contact us for more information on how PharmOut can partner with your organization and provide Australian QPPV, Local Contact Persons with Pharmacovigilance (LPPV) and related services.
