One of the key elements of a robust pharmacovigilance system is the Management Review, which is a periodic and systematic evaluation of the performance, adequacy and effectiveness of the system and its quality system.
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. It aims to ensure that medicines are safe and effective for patients and that the benefits outweigh the risks. Pharmacovigilance is a dynamic and evolving field that requires constant monitoring and evaluation of the safety data generated from various sources, such as clinical trials, spontaneous reports, literature, registries, databases, and social media.
According to the Guideline on good pharmacovigilance practices (GVP) Module I, the management review should be conducted by senior management with executive responsibility for pharmacovigilance at regular intervals in a risk-based manner.
It is absolutely compulsory that the Responsible Person is present at these meetings.
The management review should cover aspects such as:
The management review should result in a written report that documents the findings, conclusions, recommendations and actions to be taken. The report should be approved by senior management and communicated to relevant stakeholders within and outside the organisation. The report should also be kept as part of the pharmacovigilance system master file (PSMF), which is a detailed description of the pharmacovigilance system used by the marketing authorisation holder (MAH).
The management review is important for several reasons.
First, it provides an opportunity for senior management (along with the RP) to demonstrate their commitment and leadership in ensuring the quality and effectiveness of the pharmacovigilance system.
Second, it enables the MAH to monitor and measure the performance of the pharmacovigilance system against predefined objectives and indicators.
Third, it facilitates the identification and resolution of any issues or gaps that may compromise the safety of patients or the compliance with regulatory requirements.
Fourth, it fosters a culture of continuous improvement and learning within the organisation.
The frequency and scope of the management review may vary depending on the size, complexity and risk profile of the MAH and its products.
It must be conducted if significant changes or events occur that may affect the pharmacovigilance system. For example, if there is a major safety concern, a product recall, a regulatory inspection or a significant organisational change. Otherwise, the meeting ought to occur at regular intervals such as on a monthly basis. As always, the RP must be present.
The management review should also take into account any relevant guidance or legislation that applies to the Good Distribution Practice activities. For example, in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating medicines and medical devices and ensuring their safety, quality and efficacy.
The MHRA also publishes guidance on other aspects of pharmacovigilance, such as adverse drug reactions (ADRs), IT systems, legislation, licensing, oversight and monitoring.
In addition, for products authorised for sale or supply in Northern Ireland, EU pharmacovigilance requirements will continue to apply in addition to UK requirements. This means that MAHs will need to comply with the EU Guidelines on Good Distribution Practice (GDP) of medicinal products for human use, which describe the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain.
In conclusion, management reviews are essential for ensuring that MAHs have an effective Quality Management System in place that protects patients’ health and meets regulatory expectations. Management reviews should be conducted regularly, comprehensively and systematically by senior management, with executive responsibility for overall pharmacovigilance. The RP must be present in these review meetings.
Management reviews must consider any relevant guidance or legislation changes that applies to their products and markets. By doing so, MAHs can demonstrate their commitment to patient safety, quality improvement and regulatory compliance.
If you wish to know more, call us for a free 5 minute consultation, or you can use the contact form below. Alternatively, email us at info@ukgdpassociation.co.uk if your requirements or issues are more complex.
A selection of useful links to associated subjects are shown below.
Online GDP Webinar for RPs and Management
Self Inspections & First Party Audits
EU GDP Guidelines (2013/C 343/01) Chapter 1.4
Gov.uk - Guidance notes for applicants and holders of a WDA (H) license
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