Implementation of efficient quality management systems in organizations engaged in preclinical and clinical trials and pharmacovigilance

2018

Регуляторные исследования и экспертиза лекарственных средств, Vol 7, Iss 2, Pp 126-132 (2018)

The article analyses main quality assurance requirements for organizations that participate in preclinical and clinical trials and pharmacovigilance. It describes the key elements of the quality management system, provides practical advice on their implementation, and reviews the most common mistakes. The author draws attention to the necessity of implementing a holistic, risk-oriented process approach at all stages of drugs development, the importance of improving control over manufacture and circulation of investigational drugs, the need to make trial results available to general public and academic community and to apply the quality by design concept to preclinical and clinical trials in a similar way as it is now applied to drug manufacture.

article

Russian

Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’), 2018.

доклинические исследования, клинические исследования, обеспечение качества, контроль качества, система менеджмента качества, фармаконадзор, управление качеством, preclinical trials, clinical trials, quality assurance, quality control, quality management system, pharmacovigilance, quality management, Medicine (General), R5-920