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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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Autors principals: S. V. Glagolev, Yu. V. Olefir, B. K. Romanov, R. N. Alyautdin
Format: Artigo
Idioma:Russo
Publicat: Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation 2018-02-01
Col·lecció:Безопасность и риск фармакотерапии
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Accés en línia:https://www.risksafety.ru/jour/article/view/48
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