Local QPPV / QPPV (PV Qualified Person)

In the complex landscape of drug safety and pharmacovigilance, the term QPPV (Qualified Person Responsible for Pharmacovigilance) and local QPPV (or LQPPV), plays a critical role. As the pharmaceutical industry continues to evolve and regulations become increasingly stringent, the importance of a QPPV/Local QPPV cannot be overstated.

The primary goal of pharmacovigilance is to improve patient safety and ensure that the benefits of pharmaceutical products outweigh their risks. This is where the QPPV/Local QPPV steps in as a key player in ensuring compliance with pharmacovigilance requirements and safeguarding public health.

Who is the QPPV/Local QPPV?

The QPPV/Local QPPV is an individual who possesses the required qualifications and expertise in the area of pharmacovigilance. They are accountable for the implementation and management of the pharmacovigilance system within an organization. Notably, the QPPV/Local QPPV is usually tasked with ensuring that the processes for monitoring, reporting, and analyzing adverse drug reactions (ADRs) are efficient and compliant with regulatory standards.

Key Responsibilities of the QPPV

Oversight of Pharmacovigilance System: Qualified Person for Pharmacovigilance is responsible for ensuring that the pharmacovigilance system is maintained and operates within the legal and regulatory frameworks established by health authorities across different countries.

Adverse Event Reporting: The Qualified Person for Pharmacovigilance oversees the reporting of adverse drug reactions to the relevant health authorities. This involves thorough monitoring, evaluation, and documentation of all cases of ADRs.

Risk Assessment and Management: The QPPV/Local QPPV is involved in the assessment of risks associated with drugs throughout their lifecycle, from development through post-marketing. This includes evaluating new safety information and deciding whether further risk mitigation strategies are required.

Communication with Regulatory Authorities: One of the core duties of the Qualified Person for Pharmacovigilance is to maintain open lines of communication with regulatory bodies. They provide updates on the safety profiles of products and ensure compliance with the requirements for reporting and communication of safety data.

Training and Education: The Qualified Person for Pharmacovigilance plays a crucial role in training the staff involved in pharmacovigilance activities. They ensure that the team is knowledgeable about the latest regulatory updates and compliant with industry best practices.

Contributing to Safety Reports: The QPPV/Local QPPV is often involved in the creation of Periodic Safety Update Reports (PSURs) and Risk Evaluation and Mitigation Strategies (REMS), which are essential tools for health authorities to assess ongoing safety data.

Procedure-Demo for Local QPPV/QPPV

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The Significance of the QPPV Role

The Qualified Person for Pharmacovigilance role is of paramount importance in the pharmaceutical industry for several reasons:

Patient Safety: The primary responsibility of the Qualified Person for Pharmacovigilance is to protect patients. By diligently monitoring and reporting adverse effects, they play a critical role in minimizing risks associated with pharmaceutical products.

Regulatory Compliance: With increasing scrutiny from regulatory authorities, having a qualified Qualified Person for Pharmacovigilance ensures that companies remain compliant with international regulations, thus avoiding legal repercussions and maintaining their reputation.

Strategic Decision-Making: The insights and data analyzed by the QPPV/Local QPPV inform strategic decisions regarding product safety, necessary labeling changes, or potential withdrawal of products from the market.

Public Trust: Effective pharmacovigilance and the presence of a QPPV/Local QPPV reinforce public trust in the safety and efficacy of medications, which is essential for the success of the pharmaceutical industry.

The role of the QPPV/Local QPPV is integral to the safety and efficacy of pharmaceutical products. As industry demand for robust pharmacovigilance systems grows, the responsibilities and significance of the QPPV/Local QPPV will continue to evolve. Ensuring that these professionals are adequately trained and resourced is essential for the protection of public health and the continuous improvement of drug safety practices. The importance of the QPPV/Local QPPV continues to highlight the fundamental relationship between adherence to regulations, patient safety, and maintaining trust in health care systems worldwide.

QPPV/Local QPPV Service

PharmExpert LLC provides MAHs with QPPV/Local QPPV services. Pharmacovigilance (PV) specialists of PharmExpert appointed as QPPV/Local QPPV have an adequate theoretical and practical knowledge for the performance of PV activities. Moreover, the QPPV/Local QPPV has skills for the management of PV systems as well as expertise or access to expertise in relevant areas such as medicine, pharmaceutical sciences as well as epidemiology and biostatistics.

PharmExpert PV qualified persons establish and maintain the MAH’s PV system, promote, and improve compliance with the legal requirements. Particularly, the QPPVs/Local QPPVs ensure and verify the information contained in the PSMF is an accurate and up-to-date reflection of the PV system.

PharmExpert’ Qualified Person for Pharmacovigilance has oversight particularly on:

standard operating procedures;
contractual arrangements;
database operations;
compliance data regarding quality;
completeness and timeliness of expedited reporting;
submission of periodic update reports;
protocols of post authorisation safety studies conducted or pursuant to a risk management plan agreed in territory of responsibility;
audit reports;
conduct of pharmacovigilance and submission of all pharmacovigilance-related documents in accordance with the
pharmacovigilance rules and guidelines;
quality, including the correctness and
completeness, of pharmacovigilance data submitted to Health Authority;
training of personnel in relation to pharmacovigilance;
if applicable, validation status, significant changes that are made to the adverse reaction database, including any failures that occurred during validation and taken corrective actions.

PharmExpert’ Qualified Person for Pharmacovigilance is able to:

gain assurance that a PV system has been implemented in accordance with the requirements;
confirm aspects of compliance in relation to the system;
full and prompt response to any request from Health Authorities for the provision of additional information necessary for the benefit-risk evaluation of therapeutic goods,
providing any other information relevant to the benefit-risk evaluation to Health Authorities
obtain information about deficiencies in the system, or non-compliance with the requirements;
obtain information about risks or actual failure in the conduct of specific aspects of PV;
providing input into the preparation of regulatory actions in response to significant safety issues (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals).
contribute to the appropriate management of and improvement(s) to the PV system.