The 13 references in paper D. Manuilov M., Д. Мануилов М. (2018) “Внедрение эффективных систем управления качеством в организациях, проводящих доклинические и клинические исследования и осуществляющих фармаконадзор // Implementation of efficient quality management systems in organizations engaged in preclinical and clinical trials and pharmacovigilance” / spz:neicon:vedomostincesmp:y:2017:i:2:p:126-132

1
State Standard Ð ISO 9001–2015. Quality management systems. Requirements. Moscow: Standartinform; 2015 (in Russian).
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2
Order of the Ministry of Health of the Russian Federation of 01.04.2016, No. 199 «On adoption of Good Laboratory Practice» (in Russian).
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3
OECD Principles of Good Laboratory Practice (as revised in 1997).
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4
Order of the Ministry of Health of the Russian Federation of 01.04.2016, No. 200n «On adoption of Good Clinical Practice» (in Russian).
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5
State Standard Ð 52379–2005. Good Clinical Practice. Moscow: Standartinform; 2005 (in Russian).
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6
Decree of the Board of the Eurasian Economic Commission of 29.12.2015 No. 185 «Draft resolution of the Eurasian Economic Commission Council «On adoption of Good Pharmacovigilance Practice of the Eurasian Economic Union» (in Russian).
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7
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. Available from: http:// www.ich.org/.
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8
ICH Q10 Pharmaceutical Quality System. International Conference on Harmonization; 2008.
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9
Integrated Addendum to ICH E6 (R1): Guideline For Good Clinical Practice E6 (R2). Step 2b version.
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10
Order of the Ministry of Trade and Industry of the Russian Federation of 14.06.2013, No. 916 «On adoption of Good Manufacturing Practice» (in Russian).
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11
FDA Guidance for Industry (2009): Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects.
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12
State Standard R ISO 31000–2010. Risk management. Principles and guidance. Moscow: Standartinform; 2010 (in Russian).
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13
ICH Q9 Quality Risk management. International Conference on Harmonization; 2006. AUTHORS NovaMedica LLC, 2nd Brestskaya street 8, Moscow 125047, Russian Federation. Manuilov DM. Head of Research and Development.
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