Preparation for the Inspection of the Pharmacovigilance System

Preparation for the Inspection of the Pharmacovigilance System

The processes of planning, performing, documenting, and follow-up of pharmacovigilance system inspections are regulated by the Good Pharmacovigilance Practices (GVP) and local regulations. These inspection processes apply mainly to marketing authorisation holders, developers of medicinal products fo...

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Bibliographic Details
Main Author:	B. K. Romanov
Format:	Article
Language:	Russian
Published:	Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2021-10-01
Series:	Безопасность и риск фармакотерапии
Subjects:	pharmacovigilance inspection pharmacovigilance system good pharmacovigilance practice gvp pharmacovigilance officer corrective and preventive action
Online Access:	https://www.risksafety.ru/jour/article/view/230

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