Conducting Pharmaceutical Inspections in the Russian Federation to Ensure Compliance with the EAEU GCP Requirements Is an Accepted Necessity
Inspections of pharmaceutical market participants to verify their compliance with good practice requirements are integral to good regulatory practices of the Member States of the Eurasian Economic Union (EAEU). The framework for Good Clinical Practice (GCP) inspections is outlined in Decision No. 78...
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| Format: | Article |
| Language: | Russian |
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Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2023-06-01
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| Series: | Безопасность и риск фармакотерапии |
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| Online Access: | https://www.risksafety.ru/jour/article/view/370 |
| _version_ | 1797224571846262784 |
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| author | A. A. Trapkova |
| author_facet | A. A. Trapkova |
| author_sort | A. A. Trapkova |
| collection | DOAJ |
| description | Inspections of pharmaceutical market participants to verify their compliance with good practice requirements are integral to good regulatory practices of the Member States of the Eurasian Economic Union (EAEU). The framework for Good Clinical Practice (GCP) inspections is outlined in Decision No. 78 of the Council of the Eurasian Economic Commission of November 3, 2016.This interview with Alla A. TRAPKOVA, Deputy General Director of the Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation, provides information on the importance, objectives, and rules of conducting GCP inspections. |
| first_indexed | 2024-03-08T22:26:52Z |
| format | Article |
| id | doaj.art-ed950bf687f2495dba3f20c926b46441 |
| institution | Directory Open Access Journal |
| issn | 2312-7821 2619-1164 |
| language | Russian |
| last_indexed | 2024-04-24T13:55:14Z |
| publishDate | 2023-06-01 |
| publisher | Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» |
| record_format | Article |
| series | Безопасность и риск фармакотерапии |
| spelling | doaj.art-ed950bf687f2495dba3f20c926b464412024-04-03T17:56:38ZrusMinistry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Безопасность и риск фармакотерапии2312-78212619-11642023-06-0111212713010.30895/2312-7821-2023-11-2-127-130296Conducting Pharmaceutical Inspections in the Russian Federation to Ensure Compliance with the EAEU GCP Requirements Is an Accepted NecessityA. A. Trapkova0Scientific Centre for Expert Evaluation of Medicinal ProductsInspections of pharmaceutical market participants to verify their compliance with good practice requirements are integral to good regulatory practices of the Member States of the Eurasian Economic Union (EAEU). The framework for Good Clinical Practice (GCP) inspections is outlined in Decision No. 78 of the Council of the Eurasian Economic Commission of November 3, 2016.This interview with Alla A. TRAPKOVA, Deputy General Director of the Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation, provides information on the importance, objectives, and rules of conducting GCP inspections.https://www.risksafety.ru/jour/article/view/370good clinical practicepharmaceutical inspectionclinical trialsmarketing authorisation of medicinal productseurasian economic union |
| spellingShingle | A. A. Trapkova Conducting Pharmaceutical Inspections in the Russian Federation to Ensure Compliance with the EAEU GCP Requirements Is an Accepted Necessity Безопасность и риск фармакотерапии good clinical practice pharmaceutical inspection clinical trials marketing authorisation of medicinal products eurasian economic union |
| title | Conducting Pharmaceutical Inspections in the Russian Federation to Ensure Compliance with the EAEU GCP Requirements Is an Accepted Necessity |
| title_full | Conducting Pharmaceutical Inspections in the Russian Federation to Ensure Compliance with the EAEU GCP Requirements Is an Accepted Necessity |
| title_fullStr | Conducting Pharmaceutical Inspections in the Russian Federation to Ensure Compliance with the EAEU GCP Requirements Is an Accepted Necessity |
| title_full_unstemmed | Conducting Pharmaceutical Inspections in the Russian Federation to Ensure Compliance with the EAEU GCP Requirements Is an Accepted Necessity |
| title_short | Conducting Pharmaceutical Inspections in the Russian Federation to Ensure Compliance with the EAEU GCP Requirements Is an Accepted Necessity |
| title_sort | conducting pharmaceutical inspections in the russian federation to ensure compliance with the eaeu gcp requirements is an accepted necessity |
| topic | good clinical practice pharmaceutical inspection clinical trials marketing authorisation of medicinal products eurasian economic union |
| url | https://www.risksafety.ru/jour/article/view/370 |
| work_keys_str_mv | AT aatrapkova conductingpharmaceuticalinspectionsintherussianfederationtoensurecompliancewiththeeaeugcprequirementsisanacceptednecessity |