Address: Valentynivska str., 4, Kharkiv, 61168
Mobile phone +38 050 381 01 42
2011 – Degree of professor (Pharmaceutical sciences);
1996 – Doctor of Science (Pharmaceuticals);
1993 –Degree of Senior Researcher;
1989 – Ph.D. in Chemical Science (Analytical Chemistry);
1985-1988 – Postgraduate study at Kharkiv State University (Analytical Chemistry);
1985-graduated from Kharkiv State University (now – Kharkiv National University) with honour (School of Chemistry) – Master of Chemistry degree.
09.2005 – now – Professor of Quality Management Department at the National University of Pharmacy (Ukraine, Kharkiv);
04.2006 – 05. 2011 – Established and headed Bioanalytical laboratory ‘Clinfarm L.T.D.’ (Pharmacokinetics and bioequivalence study) which is certified with GLP EU compliance;
06.2003 – 02.2006 – Head of Quality Systems Inspectorate, Deputy Chairman of the State Administration on Medicines and Medical devices;
05.2000 – 06.2003 – Ministry of Health of Ukraine, State Department for the Quality Control, Safety and Manufacturing of Medicines – Head of GMP Inspectorate;
10.1999 – 05.2000 – Ministry of Health of Ukraine, National Agency for Quality and Safety Control of Food Products and Medicines – Head of Quality Control Inspectorate;
1992 -1999 – Chairman of the Commission on sorbents and blood substitutes of the Ukrainian State Pharmacopoeial Committee;
1991 – 1999 – State Scientific Centre of Drugs – Head of Analytical Chemistry Laboratory;
1988-1990 – State Scientific Centre of Drugs- Junior Researcher; Researcher.
Quality systems in Pharmaceutical sphere, assessment of the quality control and manufacturing documentation
08.2014 – carried out training workshop ‘Fundamentals of Good Manufacturing Practices’ which was organized by USAID and United States Pharmacopeial Convention within program ‘Promoting the Quality of Medicines’ in the Republic of Kazakhstan;
2011-now – have carried out over 70 consulting GMP-audits at the manufacturing sites in Russia, Belarus, Kazakhstan, Croatia, Bosnia and Herzegovina, Monaco, Japan, China, India, Turkey, Scotland, Sweden, Ireland, Italy, Taiwan, Bulgaria etc. in order to be prepared to official GMP-inspections;
2007-now – have organized and participated as lecturer more than 100 training seminars on GMP, GDP, GLP in Ukraine, Russia, Belarus, Kazakhstan;
2006 – carried out audits of 2 bioanalytical labs with GLP compliance in Germany and Poland;
2004 – 2013 – carried out trainings at the State Training Centre of Good manufacturing/distribution practice in Ukraine; carried out GMP/GDP training courses for official GMP-inspectors of the Republic of Kazakhstan (2005, 2011);
2004-2010 – participated in all stages of accession to the PIC/S from preparation of the application to audit execution of the State Administration of Ukraine on Medicinal Products by the PIC/S in 2010;
2003-2012 – participated in 8 annual PIC/S Seminars and 4 PIC/S Committee Meetings of Officials;
2000 – now – took part in translation and adaptation over 25 Ukrainian guidelines, which are harmonised with EU legislation, and also participated in development of the State Pharmacopeia of Ukraine (the 1st and 2nd editions);
2000 – 2006 – carried out about 150 official inspections of medicines manufacturing sites in Ukraine; conducted 9 training and more than 30 official GMP inspections in Ukraine and foreign countries (India, Turkey, Bulgaria) as the leader inspector; audited more than 20 Ukrainian quality control labs within the accreditation process;
organised and took part in technical assessment of over 1000 manufacturing documentations of medicines included in the quality part of the marketing authorization dossiers;
2000-2002 – studied GMP/GDP theory and practice, inspection/audit methods, organisation and training as a trainee of TACIS projects in Ukraine ‘Assistance in Restructuring of Pharmaceutical Industry in Ukraine’ and ‘The Organisation of the National Pharmaceutical Inspectorate’ (4 certificates issued by the European Union experts certifying qualification).
1991 – 1999 – developed of 2 general monographs and over 20 monographs of the State Pharmacopoeia of Ukraine;
assessed of quality control documentations for over 200 medicines and Active Pharmaceutical Ingredients included in the quality part of the marketing authorization dossiers;
Have over 100 published scientific papers, 6 patents, 4 monographs;
Member of editorial staff in 3 scientific journals;
Languages: Russian, Ukrainian – fluent, English – upper intermediate level.
Member of the Commission of the State Service on medicines of Ukraine on the review of the inspection results in the certification of medicinal products manufacturing (2014-2015), Deputy Chairman of the Scientific and Methodological Council of the State Inspectorate Ukraine for Health (2009-2010).
Has been a scientific adviser for 5 Ph.D. and over 20 Masters specializing in pharmaceutical manufacture, quality control and quality management systems for pharmaceuticals;
International activities (membership in professional associations): a member of Industrial pharmacy section of International Pharmaceutical Federation (FIP) from 2006
Teached disciplines: Audit of quality management systems, quality management systems, quality management of technological processes