Implementation of efficient quality management systems in organizations engaged in preclinical and clinical trials and pharmacovigilance
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 mistake...
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| Format: | Article |
| Language: | Russian |
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NEICON ISP LLC
2018-02-01
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| Series: | Ведомости Научного центра экспертизы средств медицинского применения |
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| Online Access: | https://www.vedomostincesmp.ru/jour/article/view/131 |
| _version_ | 1797199085245038592 |
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| author | D. M. Manuilov |
| author_facet | D. M. Manuilov |
| author_sort | D. M. Manuilov |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-07T19:18:25Z |
| format | Article |
| id | doaj.art-bd5bb6f9e6ab4ddab990b6544ef5c477 |
| institution | Directory Open Access Journal |
| issn | 1991-2919 2619-1172 |
| language | Russian |
| last_indexed | 2024-04-24T07:10:09Z |
| publishDate | 2018-02-01 |
| publisher | NEICON ISP LLC |
| record_format | Article |
| series | Ведомости Научного центра экспертизы средств медицинского применения |
| spelling | doaj.art-bd5bb6f9e6ab4ddab990b6544ef5c4772024-04-21T11:46:33ZrusNEICON ISP LLCВедомости Научного центра экспертизы средств медицинского применения1991-29192619-11722018-02-0172126132129Implementation of efficient quality management systems in organizations engaged in preclinical and clinical trials and pharmacovigilanceD. M. Manuilov0NovaMedica LLCThe 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.https://www.vedomostincesmp.ru/jour/article/view/131доклинические исследованияклинические исследованияобеспечение качестваконтроль качествасистема менеджмента качествафармаконадзоруправление качествомpreclinical trialsclinical trialsquality assurancequality controlquality management systempharmacovigilancequality management |
| spellingShingle | D. M. Manuilov Implementation of efficient quality management systems in organizations engaged in preclinical and clinical trials and pharmacovigilance Ведомости Научного центра экспертизы средств медицинского применения 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 |
| title | Implementation of efficient quality management systems in organizations engaged in preclinical and clinical trials and pharmacovigilance |
| title_full | Implementation of efficient quality management systems in organizations engaged in preclinical and clinical trials and pharmacovigilance |
| title_fullStr | Implementation of efficient quality management systems in organizations engaged in preclinical and clinical trials and pharmacovigilance |
| title_full_unstemmed | Implementation of efficient quality management systems in organizations engaged in preclinical and clinical trials and pharmacovigilance |
| title_short | Implementation of efficient quality management systems in organizations engaged in preclinical and clinical trials and pharmacovigilance |
| title_sort | implementation of efficient quality management systems in organizations engaged in preclinical and clinical trials and pharmacovigilance |
| topic | 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 |
| url | https://www.vedomostincesmp.ru/jour/article/view/131 |
| work_keys_str_mv | AT dmmanuilov implementationofefficientqualitymanagementsystemsinorganizationsengagedinpreclinicalandclinicaltrialsandpharmacovigilance |