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PSMFs play a critical part in pharmacovigilance systems, and their update process demands expert management to maintain compliance and safety.
The Pharmacovigilance System Master File (PSMF) is a comprehensive version-controlled document written in English, and an essential regulatory requirement for pharmacovigilance systems within European Union (EU). And the extract from a PSMF, Summary of Pharmacovigilance System (SPS), is also a mandatory part of a registration dossier.
The requirement for a PSMF is applicable not only within the 27 countries that make up the EU, but also in over 40 other jurisdictions, where there is a regulatory requirement for a MAH to have a description of the pharmacovigilance system in place for a product.
Whilst the PV system description within the EU PSMF format is accepted in some countries outside of the EU, many other countries have their specific requirements regarding the format and content for a PV system description file.
Its purpose is to hold structured, detailed, and up-to-date safety-related information about the products and pharmacovigilance system/s used by a Marketing Authorization Holder (MAH).
Systematically monitored and evaluated, it provides regulatory authorities with a clear overview of a MAH’s ability to ensure the safety of its products, highlighting the processes and methodologies employed in its drug safety surveillance activities.
A PSMF also plays a pivotal role in facilitating inspections and audits, ensuring that a MAH is consistently following the pharmacovigilance standards and relevant Good Vigilance Practices (GVP) required by law to safeguard public health.
Qualified Person Responsible for Pharmacovigilance (QPPV): Appointment and support for the QPPV, responsible for the establishment and maintenance of the pharmacovigilance system.
The organizational structure: The roles and responsibilities of pharmacovigilance personnel, a description of pharmacovigilance sites and activities.
Sources of Safety Data: Comprehensive collection of safety data from all relevant sources, including clinical trials and spontaneous reports.
Computerised systems and databases: The location, functionality and operational responsibility for computerised systems and databases used to receive, collate, record and report safety information.
Pharmacovigilance Processes: Signal Management, monitoring of product risk-benefit profile, implementation and maintenance of a proactive and effective Risk Management System, case management process, and PSUR Scheduling, production and submission.
Quality System: Establishment of the quality system/s to oversee the performance and integrity of pharmacovigilance activities. Includes training and resource management to ensure that all personnel involved are adequately trained and competent, and Audit Planning and execution to evaluate the effectiveness of the pharmacovigilance system and its compliance.
Regulatory Submissions and Compliance: Ensuring timely submissions of pharmacovigilance-related documents and compliance with regulatory obligations.
iVigee uses a comprehensive PSMF creation and subsequent quarterly update process to ensure you remain fully compliant. The timing of all activities is coordinated around a Data Lock Point (DLP) which is set every 3 months.
DLP (-15 days)
A Kick-off Meeting will be organised to define roles and timelines.
DLP (-10 days)
The PSMF author issues requests for information to all pertinent stakeholders.
DLP
The cut-off date for any new information or data that will be incorporated into the PSMF.
DLP (+7 days)
Delivery of all PSMF source data.
DLP (+14 days)
Draft 1 of the PSMF undergoes a comprehensive quality control (QC) assessment and subsequent review by the Marketing Authorization Holder (MAH).
DLP (+21 days)
Draft 2 of the PSMF undergoes a second assessment and review process.
DLP (+28 days)
Following the QCs and reviews, the PSMF is finalised and distributed for signature approvals.
DLP (+30 days)
The PSMF is signed-off and becomes effective.
iVigee offers an expert PSMF outsourcing service, with creation and maintenance combining deep industry knowledge with proven, efficient, and compliant processes.
Our team of professionals have been instrumental in the development of the PSMF since its introduction to the pharmacovigilance world at the beginning of the millennium. Over the years, we have acquired a depth of experience, incorporating best practices from various sectors including regulatory agencies, pharmaceutical companies, and other service providers.
Many of our experts also provide PSMF training for international organisations such as the DIA and RQA, in addition to conducting audits and targeted PSMF gap analyses. These activities help identify potential issues, enabling us to recommend the most effective solution.
This diverse background guarantees a PSMF solution, that is not only comprehensive but also tailored to meet industry standards and client needs.
And through our world leading iViReg Regulatory Intelligence platform, we have the latest, PV specific information on the PSMF requirements in over 90 countries, including where PSMFs are accepted, and where other formats are required.
iVigee is committed to creating simple, powerful, and elegant pharmacovigilance and technology solutions, an ethos that is at the core of how we approach PSMF requirements and full compliance with Good Pharmacovigilance Practices (GVP) Module II.
