Preparation for the Inspection of the Pharmacovigilance System

Романов, Б. К.

doi:10.30895/2312-7821-2021-9-3-111-116

Bezopasnost' i risk farmakoterapii

2021

DOI: 10.30895/2312-7821-2021-9-3-111-116

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Preparation for the Inspection of the Pharmacovigilance System

Б. К. Романов

Abstract: Федеральное государственное автономное образовательное учреждение высшего образования «Российский национальный исследовательский медицинский университет имени Н. И. Пирогова» Министерства здравоохранения Российской Федерации, ул. Островитянова, д. 1, Москва, 117997, Российская Федерация Резюме. Процессы планирования, проведения, отчетности и последующих мер для инспекций систем фармаконадзора регламентированы Правилами надлежащей практики фармаконадзора (Good pharmacovigilance practices, GVP) и локальными н… Show more

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Rate Setting for Labour Costs Related to Pharmacovigilance System Inspections

Abdrakhmanov¹,

Alyautdin²,

Крашенинников

et al. 2022

Bezopasnost' i risk farmakoterapii

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The inspection of pharmacovigilance systems is regulated by the Good Pharmacovigilance Practices (GVP) and local laws and regulations. Inspections may be carried out by audit teams of competent authorities as part of regulatory activities or business agreements. So far, there have been no studies dealing with rate setting for competent authorities labour costs in connection with onsite or documentary inspections of pharmacovigilance systems.The aim of the study was to develop scientifically valid rate setting criteria for labour costs related to onsite or documentary inspections of pharmacovigilance systems.Materials and methods: the assessment of labour costs was carried out by surveying experts of two Eurasian Economic Union (EAEU) countries who have experience in preparing and conducting evaluation and inspection of pharmacovigilance systems. The calculation of the experts’ time costs was performed automatically using the CrocoTime software. The expected workload for experts in 2022 was estimated based on the reports over the last 5 years (2016–2020) containing information on the number of foreign marketing authorisations, and the number of medicines under development according to national registers of medicinal products of the EAEU member states.Results: the study calculated the average expert labour costs and estimated workload for the EAEU competent authorities in 2022. It was demonstrated that the average labour costs are comparable in EAEU member states, however, estimated amount of labour may change (both increase or decrease).Conclusions: further study of rate setting for labour costs related to pharmacovigilance documentary inspections and study of competent authorities staffing could be performed by a dedicated division, e.g. of the Eurasian Academy of Good Practices. A constructive discussion of approaches to the improvement of control over pharmacovigilance systems will increase availability of efficacious and safe medicines of assured quality for the population and help pharmaceutical companies and regulatory authorities manage financial and reputational risks.

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Rate Setting for Labour Costs Related to Pharmacovigilance System Inspections

Abdrakhmanov¹,

Alyautdin²,

Крашенинников

et al. 2022

Bezopasnost' i risk farmakoterapii

View full text Add to dashboard Cite

show abstract

Audits and inspections of pharmacovigilance systems in Russia

Таубэ

Романов

2023

GCP

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The implementation of pharmacovigilance activities is impossible in isolation from compliance with the quality requirements of medicines and the activities of pharmaceutical and medical organizations throughout the pharmaceutical practice, as well as without access to sales plans, sales results and full relevance of information on drug conditions in all markets and in all cases of application. Properly conducted audit or inspection evaluation of the pharmacovigilance system makes it possible to identify and prevent drug safety problems at all stages of its life cycle.The aim. Development of a risk-based strategy for planning and passing audits and inspections of the pharmacovigilance system for the subsequent creation of effective programs for assessing the pharmacovigilance system on its basis.Material and methods. The study used structurallogical, empirical methods, general logical methods of scientific knowledge, methods of generalization and extrapolation.Results. The plans and results of audits and inspections of pharmacovigilance systems of Russian and foreign pharmaceutical organizations and their pharmacovigilance vendors were analyzed. A risk-based strategy and a checklist for planning internal and external audits of pharmacovigilance systems of Russian pharmaceutical organizations and their vendors for pharmacovigilance have been developed and recommendations for training internal auditors of pharmacovigilance systems and audit teams have been developed for them.Conclusion. Risk assessment indicators adapted for Russia have been developed, according to which Russian pharmaceutical organizations and their pharmacovigilance vendors can assess the likelihood of the risk of priority inclusion in the plan of Russian inspections of pharmacovigilance systems for compliance with the requirements of the good pharmacovigilance practice of the Eurasian Economic Union. Recommendations were prepared for the executive management and pharmacovigilance specialists of Russian pharmaceutical organizations in terms of assessing regulatory risks for the quality system of the pharmacovigilance system, planning and conducting audits; evaluating the relationship of pharmacovigilance with other good practices and with information from the plans and results of the organization as a whole. The indicators adapted for Russia for assessing the compliance of the pharmacovigilance system with the rules of the NPF EAEU are given.

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Preparation for the Inspection of the Pharmacovigilance System

Cited by 2 publications

References 1 publication

Rate Setting for Labour Costs Related to Pharmacovigilance System Inspections

Rate Setting for Labour Costs Related to Pharmacovigilance System Inspections

Audits and inspections of pharmacovigilance systems in Russia

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