The 13 references with contexts 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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    Îñíîâíàÿ öåëü ñèñòåìû ìåíåäæìåíòà êà÷åñòâà (ÑÌÊ) — îïðåäåëåíèå ñòàíäàðòîâ, êîòîðûì îðãàíèçàöèÿ äîëæíà ñîîòâåòñòâîâàòü, óñòàíîâëåíèå òðåáóåìîãî óðîâíÿ âîñïðîèçâîäèìîñòè è ïîñòîÿíñòâà ðåçóëüòàòîâ åå äåÿòåëüíîñòè, ñïîñîáîâ äîñòèæåíèÿ ýòèõ ðåçóëüòàòîâ è äîêóìåíòèðîâàíèÿ.  ñîîòâåòñòâèè ñ ÃÎÑÒ Ð ÈÑÎ 9001–2015 «Ñèñòåìû ìåíåäæìåíòà êà÷åñòâà. Òðåáîâàíèÿ »
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    , «ïðèìåíåíèå ñèñòåìû ìåíåäæìåíòà êà÷åñòâà ÿâëÿåòñÿ ñòðàòåãè÷åñêèì ðåøåíèåì äëÿ îðãàíèçàöèè, êîòîðîå ìîæåò ïîìî÷ü óëó÷øèòü ðåçóëüòàòû åå äåÿòåëüíîñòè è îáåñïå÷èòü ïðî÷íóþ îñíîâó äëÿ èíèöèàòèâ, îðèåíòèðîâàííûõ íà óñòîé÷èâîå ðàçâèòèå».

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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    ÑÌÊ îðãàíèçàöèé, çàíèìàþùèõñÿ ïðîâåäåíèåì äîêëèíè÷åñêèõ (ÄÊÈ) è êëèíè÷åñêèõ èññëåäîâàíèé (ÊÈ), äîëæíà ñîîòâåòñòâîâàòü ñòàíäàðòàì íàäëåæàùèõ ïðàêòèê (Good Practices, GxP), ïðåæäå âñåãî — íàäëåæàùåé ëàáîðàòîðíîé ïðàêòèêè (Good Laboratory Practice, GLP)
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    [2, 3]
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    è íàäëåæàùåé êëèíè÷åñêîé ïðàêòèêè (Good Clinical Practice, GCP) [4, 5]. Äëÿ ôàðìàöåâòè÷åñêèõ êîìïàíèé òàêæå àêòóàëüíû òðåáîâàíèÿ íàäëåæàùåé ïðàêòèêè ôàðìàêîíàäçîðà (Good Pharmacovigilance Practice, GVP) [6].

3
OECD Principles of Good Laboratory Practice (as revised in 1997).
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    ÑÌÊ îðãàíèçàöèé, çàíèìàþùèõñÿ ïðîâåäåíèåì äîêëèíè÷åñêèõ (ÄÊÈ) è êëèíè÷åñêèõ èññëåäîâàíèé (ÊÈ), äîëæíà ñîîòâåòñòâîâàòü ñòàíäàðòàì íàäëåæàùèõ ïðàêòèê (Good Practices, GxP), ïðåæäå âñåãî — íàäëåæàùåé ëàáîðàòîðíîé ïðàêòèêè (Good Laboratory Practice, GLP)
    Exact
    [2, 3]
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    è íàäëåæàùåé êëèíè÷åñêîé ïðàêòèêè (Good Clinical Practice, GCP) [4, 5]. Äëÿ ôàðìàöåâòè÷åñêèõ êîìïàíèé òàêæå àêòóàëüíû òðåáîâàíèÿ íàäëåæàùåé ïðàêòèêè ôàðìàêîíàäçîðà (Good Pharmacovigilance Practice, GVP) [6].

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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    ÑÌÊ îðãàíèçàöèé, çàíèìàþùèõñÿ ïðîâåäåíèåì äîêëèíè÷åñêèõ (ÄÊÈ) è êëèíè÷åñêèõ èññëåäîâàíèé (ÊÈ), äîëæíà ñîîòâåòñòâîâàòü ñòàíäàðòàì íàäëåæàùèõ ïðàêòèê (Good Practices, GxP), ïðåæäå âñåãî — íàäëåæàùåé ëàáîðàòîðíîé ïðàêòèêè (Good Laboratory Practice, GLP) [2, 3] è íàäëåæàùåé êëèíè÷åñêîé ïðàêòèêè (Good Clinical Practice, GCP)
    Exact
    [4, 5]
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    . Äëÿ ôàðìàöåâòè÷åñêèõ êîìïàíèé òàêæå àêòóàëüíû òðåáîâàíèÿ íàäëåæàùåé ïðàêòèêè ôàðìàêîíàäçîðà (Good Pharmacovigilance Practice, GVP) [6]. Îáùèå ïðèíöèïû îáåñïå÷åíèÿ êà÷åñòâà ïðèìåíèìû ê ëþáûì îðãàíèçàöèÿì, ó÷àñòâóþùèì â ïðîâåäåíèè èññëåäîâàíèé, íà÷èíàÿ ñ ôàðìàöåâòè÷åñêèõ êîìïàíèé è çàêàí÷èâàÿ èññëåäîâàòåëüñêèìè ëàáîðàòîðèÿìè.

5
State Standard Ð 52379–2005. Good Clinical Practice. Moscow: Standartinform; 2005 (in Russian).
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    ÑÌÊ îðãàíèçàöèé, çàíèìàþùèõñÿ ïðîâåäåíèåì äîêëèíè÷åñêèõ (ÄÊÈ) è êëèíè÷åñêèõ èññëåäîâàíèé (ÊÈ), äîëæíà ñîîòâåòñòâîâàòü ñòàíäàðòàì íàäëåæàùèõ ïðàêòèê (Good Practices, GxP), ïðåæäå âñåãî — íàäëåæàùåé ëàáîðàòîðíîé ïðàêòèêè (Good Laboratory Practice, GLP) [2, 3] è íàäëåæàùåé êëèíè÷åñêîé ïðàêòèêè (Good Clinical Practice, GCP)
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    . Äëÿ ôàðìàöåâòè÷åñêèõ êîìïàíèé òàêæå àêòóàëüíû òðåáîâàíèÿ íàäëåæàùåé ïðàêòèêè ôàðìàêîíàäçîðà (Good Pharmacovigilance Practice, GVP) [6]. Îáùèå ïðèíöèïû îáåñïå÷åíèÿ êà÷åñòâà ïðèìåíèìû ê ëþáûì îðãàíèçàöèÿì, ó÷àñòâóþùèì â ïðîâåäåíèè èññëåäîâàíèé, íà÷èíàÿ ñ ôàðìàöåâòè÷åñêèõ êîìïàíèé è çàêàí÷èâàÿ èññëåäîâàòåëüñêèìè ëàáîðàòîðèÿìè.

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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    ÷åñêèõ èññëåäîâàíèé (ÊÈ), äîëæíà ñîîòâåòñòâîâàòü ñòàíäàðòàì íàäëåæàùèõ ïðàêòèê (Good Practices, GxP), ïðåæäå âñåãî — íàäëåæàùåé ëàáîðàòîðíîé ïðàêòèêè (Good Laboratory Practice, GLP) [2, 3] è íàäëåæàùåé êëèíè÷åñêîé ïðàêòèêè (Good Clinical Practice, GCP) [4, 5]. Äëÿ ôàðìàöåâòè÷åñêèõ êîìïàíèé òàêæå àêòóàëüíû òðåáîâàíèÿ íàäëåæàùåé ïðàêòèêè ôàðìàêîíàäçîðà (Good Pharmacovigilance Practice, GVP)
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    . Îáùèå ïðèíöèïû îáåñïå÷åíèÿ êà÷åñòâà ïðèìåíèìû ê ëþáûì îðãàíèçàöèÿì, ó÷àñòâóþùèì â ïðîâåäåíèè èññëåäîâàíèé, íà÷èíàÿ ñ ôàðìàöåâòè÷åñêèõ êîìïàíèé è çàêàí÷èâàÿ èññëåäîâàòåëüñêèìè ëàáîðàòîðèÿìè. Ïðè ýòîì íåîáõîäèìî ðàçäåëÿòü ïîíÿòèÿ «îáåñïå÷åíèå êà÷åñòâà »(quality assurance, QA) è «êîíòðîëü êà÷åñòâà »(quality control, QC).

7
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. Available from: http:// www.ich.org/.
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    ïðàêòèê èíòåãðèðîâàíû â çàêîíîäàòåëüñòâî ìíîãèõ ñòðàí, â òîì ÷èñëå è Ðîññèè; ãàðìîíèçàöèÿ ýòèõ òðåáîâàíèé ïîä ýãèäîé îðãàíèçàöèè ICH (The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use — Ìåæäóíàðîäíàÿ êîíôåðåíöèÿ ïî ãàðìîíèçàöèè òåõíè÷åñêèõ òðåáîâàíèé ê ðåãèñòðàöèè ëåêàðñòâåííûõ ïðåïàðàòîâ äëÿ ìåäèöèíñêîãî ïðèìåíåíèÿ)
    Exact
    [7, 8]
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    ïîçâîëÿåò ìåæäóíàðîäíûì êîìïàíèÿì ñîçäàâàòü ãëîáàëüíûå ñèñòåìû êà÷åñòâà, åäèíûå äëÿ âñåõ ïîäðàçäåëåíèé, à ëîêàëüíûì êîìïàíèÿì — èñïîëüçîâàòü ìåæäóíàðîäíûé îïûò ïðè ïîñòðîåíèè ñîáñòâåííûõ ñèñòåì êà÷åñòâà.

8
ICH Q10 Pharmaceutical Quality System. International Conference on Harmonization; 2008.
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    ïðàêòèê èíòåãðèðîâàíû â çàêîíîäàòåëüñòâî ìíîãèõ ñòðàí, â òîì ÷èñëå è Ðîññèè; ãàðìîíèçàöèÿ ýòèõ òðåáîâàíèé ïîä ýãèäîé îðãàíèçàöèè ICH (The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use — Ìåæäóíàðîäíàÿ êîíôåðåíöèÿ ïî ãàðìîíèçàöèè òåõíè÷åñêèõ òðåáîâàíèé ê ðåãèñòðàöèè ëåêàðñòâåííûõ ïðåïàðàòîâ äëÿ ìåäèöèíñêîãî ïðèìåíåíèÿ)
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    ïîçâîëÿåò ìåæäóíàðîäíûì êîìïàíèÿì ñîçäàâàòü ãëîáàëüíûå ñèñòåìû êà÷åñòâà, åäèíûå äëÿ âñåõ ïîäðàçäåëåíèé, à ëîêàëüíûì êîìïàíèÿì — èñïîëüçîâàòü ìåæäóíàðîäíûé îïûò ïðè ïîñòðîåíèè ñîáñòâåííûõ ñèñòåì êà÷åñòâà.

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Integrated Addendum to ICH E6 (R1): Guideline For Good Clinical Practice E6 (R2). Step 2b version.
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    àóäèòîâ êà÷åñòâà âñåõ ó÷àñòíèêîâ èññëåäîâàíèé (âêëþ÷àÿ êëèíè÷åñêèå öåíòðû) äî íà÷àëà èññëåäîâàíèÿ, èçíà÷àëüíî ïðèìåíÿâøàÿñÿ â Ðîññèè òîëüêî íåêîòîðûìè çàïàäíûìè êîìïàíèÿìè, ñåãîäíÿ âñå øèðå ðàñïðîñòðàíÿåòñÿ íà ëîêàëüíîì ðûíêå; ðåãóëÿòîðû ìíîãèõ ñòðàí ââîäÿò íîâûå òðåáîâàíèÿ ê ñèñòåìàì êà÷åñòâà âñåõ îðãàíèçàöèé, ó÷àñòâóþùèõ â èññëåäîâàíèÿõ. Ïðîåêò îáíîâëåíèÿ ñòàíäàðòà ICH GCP E6 (R2)
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    ñîäåðæèò áîëüøîå êîëè÷åñòâî òðåáîâàíèé èìåííî ê ñèñòåìàì êà÷åñòâà ó÷àñòíèêîâ êëèíè÷åñêèõ èññëåäîâàíèé, îñîáåííî — ñïîíñîðîâ è ÊÈÎ. GVP â ðàìêàõ Åâðàçèéñêîãî ýêîíîìè÷åñêîãî ñîþçà (ÅÀÝÑ) òàêæå ðåãëàìåíòèðóåò òðåáîâàíèÿ ê ÑÌÊ äåðæàòåëåé ðåãèñòðàöèîííûõ óäîñòîâåðåíèé è âêëþ÷àåò âñå ýëåìåíòû ÑÌÊ, îïèñàííûå íèæå.

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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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    ÷åñêèå èññëåäîâàíèÿ (â ñîîòâåòñòâèè ñ òðåáîâàíèåì GLP), öåíòðàëüíûõ è áèîàíàëèòè÷åñêèõ ëàáîðàòîðèÿõ, ó÷àñòâóþùèõ â ïðîâåäåíèè èññëåäîâàíèé ôàðìàêîêèíåòèêè, ïîñêîëüêó òàêèå ëàáîðàòîðèè ÿâëÿþòñÿ ñóáïîäðÿä÷èêàìè ñïîíñîðà ÊÈ. ÑÌÊ äîëæíà áûòü âíåäðåíà â îðãàíèçàöèÿõ, îòâå÷àþùèõ çà ïðîèçâîäñòâî, ìàðêèðîâêó, õðàíåíèå è òðàíñïîðòèðîâêó èññëåäóåìûõ ïðåïàðàòîâ â ñîîòâåòñòâèè ñ òðåáîâàíèÿìè GMP
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    è GCP. Ôàêòè÷åñêè ñòàíäàðòîì ÿâëÿåòñÿ òðåáîâàíèå î íàëè÷èè ÑÌÊ â èññëåäîâàòåëüñêèõ öåíòðàõ, ïðîâîäÿùèõ èññëåäîâàíèÿ I ôàçû è áèîýêâèâàëåíòíîñòè. Ïîñêîëüêó òàêèå èññëåäîâàíèÿ çíà÷èòåëüíî îòëè÷àþòñÿ îò ðóòèííîé ìåäèöèíñêîé äåÿòåëüíîñòè, è äàæå îäíà îøèáêà ìîæåò çíà÷èòåëüíî ïîâëèÿòü íà ðåçóëüòàò âñåãî èññëåäîâàíèÿ, ïðåäúÿâëÿþòñÿ ïîâûøåííûå òðåáîâàíèÿ ê êâàëèôèêàöèè ïåðñîíàëà, îäíîîáðàçíîñòè è áåç

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FDA Guidance for Industry (2009): Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects.
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     èññëåäîâàòåëüñêèõ öåíòðàõ, ïðîâîäÿùèõ ÊÈ II–IV ôàçû, âíåäðåíèå ÑÌÊ ïîêà íå ðàñïðîñòðàíåíî, õîòÿ ðóêîâîäñòâî FDA (Food and Drug Administration — Óïðàâëåíèå ïî êîíòðîëþ çà êà÷åñòâîì ïðîäóêòîâ ïèòàíèÿ è ëåêàðñòâåííûõ ñðåäñòâ, ÑØÀ) ïî îáÿçàííîñòÿì èññëåäîâàòåëåé
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    ðåêîìåíäóåò âíåäðåíèå îòäåëüíûõ ýëåìåíòîâ ÑÌÊ, à ÷àñòü òàêèõ òðåáîâàíèé ïåðåíåñåíà è â GCP E6 (R2), íàïðèìåð, îáÿçàííîñòü èññëåäîâàòåëÿ êîíòðîëèðîâàòü ïðèâëå÷åííûå òðåòüè ñòîðîíû. ÓÏÐÀÂËÅÍÈÅ ÊÀ×ÅÑÒÂÎÌ Â ÎÐÃÀÍÈÇÀÖÈÈ ÃÎÑÒ Ð ÈÑÎ 9001–2015 ïîä÷åðêèâàåò âàæíîñòü «ïðîöåññíîãî ïîäõîäà »è ðèñê-îðèåíòèðîâàííîãî ìûøëåíèÿ ïðè ðàçðàáîòêå, âíåäðåíèè è ïîâûøåíèè ýôôåêòèâíîñòè ÑÌÊ («Ïðîöåññíûé ïîäõîä ïîçâîëÿ

12
State Standard R ISO 31000–2010. Risk management. Principles and guidance. Moscow: Standartinform; 2010 (in Russian).
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    Óïðàâëåíèå ðèñêàìè äëÿ êà÷åñòâà (quality risk management, QRM) Óïðàâëåíèå ðèñêàìè — îäíà èç îáëàñòåé ñîâðåìåííîé ýêîíîìè÷åñêîé íàóêè, øèðîêî èñïîëüçóþùàÿñÿ âî ìíîãèõ îòðàñëÿõ. ÃÎÑÒ Ð ÈÑÎ 31000–2010 «Ìåíåäæìåíò ðèñêà. Ïðèíöèïû è ðóêîâîäñòâî »
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    , èäåíòè÷íûé îäíîèìåííîìó ìåæäóíàðîäíîìó ñòàíäàðòó ÈÑÎ, óñòàíàâëèâàåò îáùèå ïîäõîäû ê óïðàâëåíèþ ðèñêàìè â îðãàíèçàöèè.  ôàðìàöåâòè÷åñêîé ïðîìûøëåííîñòè óñïåøíî ïðèìåíÿþòñÿ ïðèíöèïû óïðàâëåíèÿ ðèñêàìè äëÿ êà÷åñòâà (QRM), êîòîðûå ïîñòåïåííî âõîäÿò è â îáëàñòü èññëåäîâàíèé.

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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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    Ïîäõîä, îñíîâàííûé íà îöåíêå ðèñêîâ (risk-based approach, RBA), âñå øèðå ïðèìåíÿåòñÿ íà ïðîòÿæåíèè æèçíåííîãî öèêëà ëåêàðñòâåííûõ ñðåäñòâ. Íàïðèìåð, GCP E6 (R2) ââîäèò íîâûå òðåáîâàíèÿ ïî âíåäðåíèþ ïîäõîäà, îñíîâàííîãî íà îöåíêå ðèñêîâ, ïîâòîðÿþùèå ðóêîâîäñòâî ICH Q9
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    . Îñíîâíûìè ýòàïàìè ïðîöåäóðû ÿâëÿþòñÿ âûÿâëåíèå êðèòè÷åñêèõ ïðîöåññîâ è äàííûõ, âûÿâëåíèå îñíîâíûõ ðèñêîâ è èõ îöåíêà (èñïîëüçóþòñÿ øêàëû ïî âåðîÿòíîñòè íàñòóïëåíèÿ ðèñêà, åãî çíà÷èìîñòè è âîçìîæíîñòè ñâîåâðåìåííî èäåíòèôèöèðîâàòü), ðàçðàáîòêà è âíåäðåíèå ìåð ïî ñíèæåíèþ ðèñêà.