Dave Rushton
Founder
of Paradigm Shift Consulting Limited.
Dave Rushton is Founder of Paradigm Shift Consulting Limited, a Good Distribution Practice Consultancy.
Why Management Reviews are Important
Management Reviews are important in Pharmacovigilance
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 problems. 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.
Management Reviews have a part to play
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 and 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 results of audits and inspections
- The compliance with reporting obligations and timelines
- The quality and completeness of pharmacovigilance data
- The signal detection and management activities
- The risk-benefit assessment and risk minimisation measures
- The implementation and effectiveness of corrective and preventive actions
- The adequacy of resources and training
- The identification of opportunities for improvement
The Review’s Outcome
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).
Functionality
The management review is important for several reasons.
1. 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.
2. It enables the MAH to monitor and measure the performance of the pharmacovigilance system against predefined objectives and indicators.
3. It facilitates the identification and resolution of any issues or gaps that may compromise the safety of patients or the compliance with regulatory requirements.
4. It fosters a culture of continuous improvement and learning within the organisation.
How Often should a Review Happen?
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.
Ensure a Thorough and Comprehensive Report
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.
Conclusion
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.
Assistance and Support
Paradigm Shift Consulting Ltd offer a comprehensive range of courses designed to address all possible aspects of GDP operations. We run an online GDP Webinar for RPs and Management every month, with a thorough training schedule covering all 10 chapters of the EU guidelines complete with vivid examples of how things can go wrong and of course, the topic of Management Reviews and what you must do to remain within 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@gdptraining.co.uk if your requirements or issues are more complex.
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