Guidelines for the planning and implementation of pharmacovigilance systems audit
General recommendations for planning and implementing of a risk-based approach to audits of pharmacovigilance systems of Marketing Authorisation Holders are presented. A review of the general requirements for audits and audit reporting is given. The role of the pharmacovigilance system master file i...
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| Main Authors: | , , , |
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| Format: | Article |
| Language: | Russian |
| Published: |
Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2018-02-01
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| Series: | Безопасность и риск фармакотерапии |
| Subjects: | |
| Online Access: | https://www.risksafety.ru/jour/article/view/48 |
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| _version_ | 1849343281350049792 |
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| author | S. V. Glagolev Yu. V. Olefir B. K. Romanov R. N. Alyautdin |
| author_facet | S. V. Glagolev Yu. V. Olefir B. K. Romanov R. N. Alyautdin |
| author_sort | S. V. Glagolev |
| collection | DOAJ |
| description | General recommendations for planning and implementing of a risk-based approach to audits of pharmacovigilance systems of Marketing Authorisation Holders are presented. A review of the general requirements for audits and audit reporting is given. The role of the pharmacovigilance system master file in the planning of audits and inspections is discussed. The article contains practical recommendations for the Qualified Person Responsible for Pharmacovigilance in Marketing Authorisation Holders. |
| format | Article |
| id | doaj-art-fdc7d6d28a4d4f8788b6cd8b389584e7 |
| institution | Kabale University |
| issn | 2312-7821 2619-1164 |
| language | Russian |
| publishDate | 2018-02-01 |
| 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-fdc7d6d28a4d4f8788b6cd8b389584e72025-08-20T03:43:02ZrusMinistry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Безопасность и риск фармакотерапии2312-78212619-11642018-02-010351348Guidelines for the planning and implementation of pharmacovigilance systems auditS. V. Glagolev0Yu. V. Olefir1B. K. Romanov2R. N. Alyautdin3Federal Service for Surveillance in Healthcare of the Russian FederationScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsGeneral recommendations for planning and implementing of a risk-based approach to audits of pharmacovigilance systems of Marketing Authorisation Holders are presented. A review of the general requirements for audits and audit reporting is given. The role of the pharmacovigilance system master file in the planning of audits and inspections is discussed. The article contains practical recommendations for the Qualified Person Responsible for Pharmacovigilance in Marketing Authorisation Holders.https://www.risksafety.ru/jour/article/view/48аудитбезопасностьлекарственное средстволекарственный препаратфармаконадзорauditsafetydrugpharmacovigilance |
| spellingShingle | S. V. Glagolev Yu. V. Olefir B. K. Romanov R. N. Alyautdin Guidelines for the planning and implementation of pharmacovigilance systems audit Безопасность и риск фармакотерапии аудит безопасность лекарственное средство лекарственный препарат фармаконадзор audit safety drug pharmacovigilance |
| title | Guidelines for the planning and implementation of pharmacovigilance systems audit |
| title_full | Guidelines for the planning and implementation of pharmacovigilance systems audit |
| title_fullStr | Guidelines for the planning and implementation of pharmacovigilance systems audit |
| title_full_unstemmed | Guidelines for the planning and implementation of pharmacovigilance systems audit |
| title_short | Guidelines for the planning and implementation of pharmacovigilance systems audit |
| title_sort | guidelines for the planning and implementation of pharmacovigilance systems audit |
| topic | аудит безопасность лекарственное средство лекарственный препарат фармаконадзор audit safety drug pharmacovigilance |
| url | https://www.risksafety.ru/jour/article/view/48 |
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