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...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | Russian |
| Published: |
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
2018-02-01
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| Series: | Безопасность и риск фармакотерапии |
| Subjects: | |
| Online Access: | https://www.risksafety.ru/jour/article/view/48 |