Preparation for the Inspection of the Pharmacovigilance System
The processes of planning, performing, documenting, and follow-up of pharmacovigilance system inspections are regulated by the Good Pharmacovigilance Practices (GVP) and local regulations. These inspection processes apply mainly to marketing authorisation holders, developers of medicinal products fo...
Saved in:
| Main Author: | |
|---|---|
| Format: | Article |
| Language: | Russian |
| Published: |
Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2021-10-01
|
| Series: | Безопасность и риск фармакотерапии |
| Subjects: | |
| Online Access: | https://www.risksafety.ru/jour/article/view/230 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849343398295633920 |
|---|---|
| author | B. K. Romanov |
| author_facet | B. K. Romanov |
| author_sort | B. K. Romanov |
| collection | DOAJ |
| description | The processes of planning, performing, documenting, and follow-up of pharmacovigilance system inspections are regulated by the Good Pharmacovigilance Practices (GVP) and local regulations. These inspection processes apply mainly to marketing authorisation holders, developers of medicinal products for human use, and their authorised legal representatives, but they are presented from the perspective of regulatory authorities. Currently, there are no recommendations for pharmaceutical companies on how to prepare for a pharmacovigilance system inspection. The aim of the study was to develop recommendations on how pharmaceutical companies should prepare for a pharmacovigilance system inspection. The analysis of risks associated with scheduled and unscheduled inspections of pharmaceutical companies’ pharmacovigilance systems was performed with due consideration of the number of foreign marketing authorisations and the number of medicinal products under development according to the national registers of medicinal products and medical devices of the countries of the Eurasian Economic Union (EAEU), the Commonwealth of Independent States, and some European countries as of 30 June 2021. Some differences were identified in the work of Russian and foreign pharmacovigilance inspectorates, which are partially due to different numbers of EAEU-authorised medicinal products in the national markets. Based on the results obtained as well as personal experience as a pharmacovigilance officer in preparation of and participation in pharmacovigilance inspections of Russian companies by foreign regulators, implementation of corrective and preventive actions, the author of the paper has developed preliminary recommendations on how to prepare a EAEU pharmaceutical company’s pharmacovigilance system for an inspection. Effective management of pharmaceutical companies’ pharmacovigilance systems would contribute to the provision of the population with high-quality and safe medicines. |
| format | Article |
| id | doaj-art-5c678024a5c7448f8eacc1753db9057d |
| institution | Kabale University |
| issn | 2312-7821 2619-1164 |
| language | Russian |
| publishDate | 2021-10-01 |
| 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-5c678024a5c7448f8eacc1753db9057d2025-08-20T03:43:01ZrusMinistry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Безопасность и риск фармакотерапии2312-78212619-11642021-10-019311111610.30895/2312-7821-2021-9-3-111-116197Preparation for the Inspection of the Pharmacovigilance SystemB. K. Romanov0N. I. Pirogov Russian National Research Medical UniversityThe processes of planning, performing, documenting, and follow-up of pharmacovigilance system inspections are regulated by the Good Pharmacovigilance Practices (GVP) and local regulations. These inspection processes apply mainly to marketing authorisation holders, developers of medicinal products for human use, and their authorised legal representatives, but they are presented from the perspective of regulatory authorities. Currently, there are no recommendations for pharmaceutical companies on how to prepare for a pharmacovigilance system inspection. The aim of the study was to develop recommendations on how pharmaceutical companies should prepare for a pharmacovigilance system inspection. The analysis of risks associated with scheduled and unscheduled inspections of pharmaceutical companies’ pharmacovigilance systems was performed with due consideration of the number of foreign marketing authorisations and the number of medicinal products under development according to the national registers of medicinal products and medical devices of the countries of the Eurasian Economic Union (EAEU), the Commonwealth of Independent States, and some European countries as of 30 June 2021. Some differences were identified in the work of Russian and foreign pharmacovigilance inspectorates, which are partially due to different numbers of EAEU-authorised medicinal products in the national markets. Based on the results obtained as well as personal experience as a pharmacovigilance officer in preparation of and participation in pharmacovigilance inspections of Russian companies by foreign regulators, implementation of corrective and preventive actions, the author of the paper has developed preliminary recommendations on how to prepare a EAEU pharmaceutical company’s pharmacovigilance system for an inspection. Effective management of pharmaceutical companies’ pharmacovigilance systems would contribute to the provision of the population with high-quality and safe medicines.https://www.risksafety.ru/jour/article/view/230pharmacovigilanceinspectionpharmacovigilance systemgood pharmacovigilance practicegvppharmacovigilance officercorrective and preventive action |
| spellingShingle | B. K. Romanov Preparation for the Inspection of the Pharmacovigilance System Безопасность и риск фармакотерапии pharmacovigilance inspection pharmacovigilance system good pharmacovigilance practice gvp pharmacovigilance officer corrective and preventive action |
| title | Preparation for the Inspection of the Pharmacovigilance System |
| title_full | Preparation for the Inspection of the Pharmacovigilance System |
| title_fullStr | Preparation for the Inspection of the Pharmacovigilance System |
| title_full_unstemmed | Preparation for the Inspection of the Pharmacovigilance System |
| title_short | Preparation for the Inspection of the Pharmacovigilance System |
| title_sort | preparation for the inspection of the pharmacovigilance system |
| topic | pharmacovigilance inspection pharmacovigilance system good pharmacovigilance practice gvp pharmacovigilance officer corrective and preventive action |
| url | https://www.risksafety.ru/jour/article/view/230 |
| work_keys_str_mv | AT bkromanov preparationfortheinspectionofthepharmacovigilancesystem |