GCP inspection by Roszdravnadzor
https://doi.org/10.24411/2588-0519-2018-10039
Abstract
State institutions determine the rules for conducting clinical trials of drugs; therefore, they must directly monitor their conduct. The main form of control over clinical trials of drugs by the state is the inspection. This is article describes the types of inspections, the main identified violations, proposed further actions and consequences.
About the Authors
E. S. Rogov
Independent GCP/GLP auditor, Russia, Moscow
Russian Federation
Russian Federation
MD, JD, PhD, MSc, MRQA, independent GCP/GLP auditor,
Moscow, Russia
D. Yu. Belousov
http://www.healtheconomics.ru/
LLC "Center for Pharmacoeconomics Research", Moscow
Russian Federation
LLC "Center for Pharmacoeconomics Research", Moscow
Russian Federation
General Director of LLC "Center for Pharmacoeconomics Research"
SPIN code: 6067-9067
S. K. Zyryanov
Peoples' Friendship University of Russia, Moscow, Russia
Russian Federation
Russian Federation
MD, professor, Head of Department of General and Clinical
Pharmacology, Peoples' Friendship University of Russia, Moscow, Russia
A. S. Kolbin
First Pavlov State Medical University of Saint Petersburg, Saint Petersburg, Russia; Saint Petersburg State University, Saint Petersburg, Russia
Russian Federation
Russian Federation
MD, Professor, Head of the Department of Clinical Pharmacology and Evidence-Based Medicine, First St. Petersburg State Medical University named aer I.P. Pavlova; professor of the Department of Pharmacology, Medical Faculty, St. Petersburg State University, Russia, St. Petersburg
SPIN code: 7966-0845
L. I. Karpenko
JSC "Obolenskoe", Russia, Moscow Region
Russian Federation
Head of Medical Adviser Group, JSC "Obolenskoe", Russia, Moscow Region
Russian Federation
Head of Medical Adviser Group, JSC "Obolenskoe", Russia, Moscow Region
References
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Review
For citations:
Rogov E.S., Belousov D.Yu., Zyryanov S.K., Kolbin A.S., Karpenko L.I. GCP inspection by Roszdravnadzor. Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice. 2018;(1):66-76. (In Russ.) https://doi.org/10.24411/2588-0519-2018-10039
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