THE AGGREGATE APPROACH TO THE PERIODIZATION OF THE FORMATION OF THE PHARMACOVIGILANCE SYSTEM
https://doi.org/10.19163/2307-9266-2018-6-6-584-589
Abstract
The aim of this article is to systematize the known data based on facts relating to the formation of the global pharmacovigilance system, and its further use for the periodization development of the selected social institution.
Materials and methods. The development of the periodization of the historical development of the world pharmacovigilance system was carried out using the systematic, epistemological, historical descriptive methods, as well as using the method of generalization.
Results. The results of the study made it possible to identify a number of stages in the global development and institutionalization of pharmacovigilance.
Conclusion. The carried out research confirmed that the aggregate approach applied to the global genesis of the world pharmacovigilance system is an effective scientific and methodological technique that contributes to the development of a new level of application and systematization of knowledge about pharmacovigilance as a complex institution, conglomerating in-house science and practical interstate activity.
About the Author
A. Е. Krasheninnikov
National Pharmacovigilance Research Center
Russian Federation
Russian Federation
Krasheninnikov Anatoly Evgenievich – PhD (Pharmacy).
2/2, Malaya Sukhrevskaya Str., Moscow, 127051
References
1. Bobryshov SV. Sravnitel’nyj analiz podhodov k periodizacii razvitiya pedagogicheskih teorij i koncepcij i obrazovatel’noj praktiki [Comparative analysis of approaches to the periodization of the development of pedagogical theories and concepts and educational practice] News of South Federal University. Technical science. 2006;1:48–57. Russian.
2. Krasheninnikov AE, Matveev AV. Farmakonadzor kak effektivnyj instrument sovershenstvovaniya menedzhmenta kachestva farmacevticheskoj deyatel’nosti: etapy razvitiya i perspektivy [Pharmacovigilance as an effective tool for improving the quality management of pharmaceutical activities: stages of development and prospectives]. Crimean Journal of Experimental and Clinical Medicine. 2017;7(4):43–47. Russian.
3. Usmonov A. Istoricheskaya nauka i civilizacionnyj podhod [Historical Science and Civilizational Approach]. Scientific notes of Khudzhand State University. Acad. B. Gafurov. 2012;1(29):135–147. Russian.
4. Ivonina OI. K voprosu o periodizacii istorii Novogo i Novejshego vremeni [To the question of the periodization of the history of the New and Newest Times]. Siberian Pedagogical Journal. 2013;1:4–59. Russian.
5. Bogopolskii PM, Kabanova SA, Goldfarb YuS. O kriteriyah periodizacii istorii chastnyh oblastej medicin [About criteria of periodization of history of particular areas of medicine]. Problems of Social Hygiene, Public Health and History of Medicine. 2015;4:58–61. Russian.
6. Federal’nyj zakon ot 12.04.2010 №61-FZ «Ob obrashchenii lekarstvennyh sredstv». [The Federal Law of 12 April 2010 №61-FL «On the circulation of medicinal products»]. Russian newspaper, 14 Apr 2010, No 78. Russian.
7. The importance of pharmacovigilance. Safety Monitoring of medicinal products. United Kingdom: World Health Organization, 2002. – 52 p. – Available at: http://apps.who.int/medicinedocs/en/d/Js4893e/#Js4893e. (аccessed 11 April 2018).
8. Jakimo AL. Navigating the U.S. Food and Drug Administration’s Regulatory Science Initiative: An Imperative for Stem Cell Research and Regenerative medicine Advocates. Stem Cell Dev. 2013;22(1):73–8. DOI: 10.1089/scd.2013.0386.
9. Watson KD. Medical and Chemical Expertise in English Trials for Criminal Poisoning, 1750–1914. Med Hist. 2006;50(3):373–90.
10. Adverse Drug Reactions Monitoring. The World Health Organization. Available at: http://www.who.int/medicines/areas/quality_safety/safety_efficacy/advdrugreactions/en/. (аccessed 10 September 2018).
Review
For citations:
Krasheninnikov A.Е. THE AGGREGATE APPROACH TO THE PERIODIZATION OF THE FORMATION OF THE PHARMACOVIGILANCE SYSTEM. Pharmacy & Pharmacology. 2018;6(6):584-589. (In Russ.) https://doi.org/10.19163/2307-9266-2018-6-6-584-589
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