Rate Setting for Labour Costs Related to Pharmacovigilance System Inspections
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 de...
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| Format: | Article |
| Language: | Russian |
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Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2022-04-01
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| Series: | Безопасность и риск фармакотерапии |
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| Online Access: | https://www.risksafety.ru/jour/article/view/234 |
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| author | M. Abdrakhmanov R. N. Alyautdin A. E. Krasheninnikov B. K. Romanov |
| author_facet | M. Abdrakhmanov R. N. Alyautdin A. E. Krasheninnikov B. K. Romanov |
| author_sort | M. Abdrakhmanov |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-e95c45c62f6c44d9a551c2829bcd6bc2 |
| institution | Matheson Library |
| issn | 2312-7821 2619-1164 |
| language | Russian |
| publishDate | 2022-04-01 |
| publisher | Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» |
| record_format | Article |
| series | Безопасность и риск фармакотерапии |
| spelling | doaj-art-e95c45c62f6c44d9a551c2829bcd6bc22025-08-04T10:16:31ZrusMinistry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Безопасность и риск фармакотерапии2312-78212619-11642022-04-01101131810.30895/2312-7821-2022-10-1-13-18209Rate Setting for Labour Costs Related to Pharmacovigilance System InspectionsM. Abdrakhmanov0R. N. Alyautdin1A. E. Krasheninnikov2B. K. Romanov3National Center for Expertise of Medicines and Medical DevicesScientific Centre for Expert Evaluation of Medicinal ProductsNational Pharmacovigilance Research Center; N.I. Pirogov Russian National Research Medical UniversityN.I. Pirogov Russian National Research Medical University; Eurasian Academy of Good PracticesThe 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.https://www.risksafety.ru/jour/article/view/234pharmacovigilancepharmacovigilance systemevaluationinspectionrate settinglabour costsgood pharmacovigilance practicegvp |
| spellingShingle | M. Abdrakhmanov R. N. Alyautdin A. E. Krasheninnikov B. K. Romanov Rate Setting for Labour Costs Related to Pharmacovigilance System Inspections Безопасность и риск фармакотерапии pharmacovigilance pharmacovigilance system evaluation inspection rate setting labour costs good pharmacovigilance practice gvp |
| title | Rate Setting for Labour Costs Related to Pharmacovigilance System Inspections |
| title_full | Rate Setting for Labour Costs Related to Pharmacovigilance System Inspections |
| title_fullStr | Rate Setting for Labour Costs Related to Pharmacovigilance System Inspections |
| title_full_unstemmed | Rate Setting for Labour Costs Related to Pharmacovigilance System Inspections |
| title_short | Rate Setting for Labour Costs Related to Pharmacovigilance System Inspections |
| title_sort | rate setting for labour costs related to pharmacovigilance system inspections |
| topic | pharmacovigilance pharmacovigilance system evaluation inspection rate setting labour costs good pharmacovigilance practice gvp |
| url | https://www.risksafety.ru/jour/article/view/234 |
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