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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Bibliographic Details
Main Authors: S. V. Glagolev (Author), Yu. V. Olefir (Author), B. K. Romanov (Author), R. N. Alyautdin (Author)
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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3rd Floor Main Library

Holdings details from 3rd Floor Main Library
Call Number: A1234.567
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