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: | Book |
| Published: |
Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»,
2018-02-01T00:00:00Z.
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| Subjects: | |
| Online Access: | Connect to this object online. |
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