Our Team
OUR TEAM
OUR TEAM
Spichak Irina Vladimirovna
Executive Director of the Eurasian Academy of Good Practices
Doctor of Pharmaceutical Sciences, Professor
Education: - Kursk State Medical Institute, Faculty of Pharmacy, diploma with honors, qualification - pharmacist;
-St. Petersburg University of Engineering and Economics, Department of Economics and Management, qualification - economic manager;
- "Moscow Institute of Steel and Alloys" - Quality Management;
- High school teacher.
Honors: 1993 - Degree of Candidate of Pharmaceutical Sciences (All-Union Scientific Research Institute of Pharmacy, Moscow);
2002 - Received the title of associate professor;
2004 - Doctor of Pharmaceutical Sciences (PFUR, Moscow);
2010 - Received the title of professor
Length of service in the industry: The total experience of pedagogical work in the industry is 33 years. During this period she will go from graduate student to head of department, dean of faculty and director of the institute
Special Achievements: • Head of the pilot innovative project of the Ministry of Health of the Russian Federation "Formation of the quality system of education in higher medical education institutions", which was successfully implemented and became the methodological basis for the formation of quality systems of education in universities of the Russian Federation (2003).;
• Open University Tutor, UK (International Institute of Management LINK);
• Expert of the All-Russian Public Organization "Medical League of Russia" (accreditation of educational activities of medical universities in Russia);
• Expert of the Ministry of Education and Science of the Russian Federation (accreditation of educational activities of Russian universities);
• Member of the Russian Ministry of Education and Science's Department of Medical and Pharmaceutical Education;
• Member of the Coordinating Council for the Development of Continuing Medical and Pharmaceutical Education of the Ministry of Health of the Russian Federation;
• Member of the working group of the Ministry of Education and the Ministry of Health under the President of Russia on professional competencies;
• Member of the Dissertation Council on Pharmacy at Sechenov Moscow State Medical University (Moscow);
• Member of the editorial board of 3 scientific journals, etc.
He is the author of more than 50 educational and methodical publications, 2 textbooks recommended by the Federal Educational-Methodical Association for students of universities studying in the specialty "Pharmacy", as well as 4 monographs..
Within the framework of the scientific school under the leadership of Spichak I.V. 6 candidate dissertations were defended, 3 candidate dissertations and one doctoral dissertation are being prepared for defense.
I.V. Spichak has published more than 300 scientific works and is the author of 7 patents. Significant recognition of scientific achievements should also include international awards for innovative developments:
- Gold Medal at the International Exhibition of Innovation (Seoul, 2016);
- Bronze Medal of the All-Asia Science and Technology Innovation Exhibition (Seoul, 2016);
- Gold medal of the international exhibition "Rosbiotech" (Moscow, 2017);
- Gold medal of the international exhibition "Rosbiotech" (Moscow, 2018), etc..
I.V. Spichak is the Executive Director of the Eurasian Academy of Good Practices from 2021 to the present time
Irina Spichak is a promoter of pharmaceutical industry and professional education in the Russian Federation, a sought-after expert and speaker at professional industry platforms.
For her diligent work and achievements in professional activities, she has received numerous awards from the Ministry of Health and Social Protection of the Russian Federation and the Ministry of Education and Science of the Russian Federation. She received the Strakhov Award in the category "Education".
-St. Petersburg University of Engineering and Economics, Department of Economics and Management, qualification - economic manager;
- "Moscow Institute of Steel and Alloys" - Quality Management;
- High school teacher.
Honors: 1993 - Degree of Candidate of Pharmaceutical Sciences (All-Union Scientific Research Institute of Pharmacy, Moscow);
2002 - Received the title of associate professor;
2004 - Doctor of Pharmaceutical Sciences (PFUR, Moscow);
2010 - Received the title of professor
Length of service in the industry: The total experience of pedagogical work in the industry is 33 years. During this period she will go from graduate student to head of department, dean of faculty and director of the institute
Special Achievements: • Head of the pilot innovative project of the Ministry of Health of the Russian Federation "Formation of the quality system of education in higher medical education institutions", which was successfully implemented and became the methodological basis for the formation of quality systems of education in universities of the Russian Federation (2003).;
• Open University Tutor, UK (International Institute of Management LINK);
• Expert of the All-Russian Public Organization "Medical League of Russia" (accreditation of educational activities of medical universities in Russia);
• Expert of the Ministry of Education and Science of the Russian Federation (accreditation of educational activities of Russian universities);
• Member of the Russian Ministry of Education and Science's Department of Medical and Pharmaceutical Education;
• Member of the Coordinating Council for the Development of Continuing Medical and Pharmaceutical Education of the Ministry of Health of the Russian Federation;
• Member of the working group of the Ministry of Education and the Ministry of Health under the President of Russia on professional competencies;
• Member of the Dissertation Council on Pharmacy at Sechenov Moscow State Medical University (Moscow);
• Member of the editorial board of 3 scientific journals, etc.
He is the author of more than 50 educational and methodical publications, 2 textbooks recommended by the Federal Educational-Methodical Association for students of universities studying in the specialty "Pharmacy", as well as 4 monographs..
Within the framework of the scientific school under the leadership of Spichak I.V. 6 candidate dissertations were defended, 3 candidate dissertations and one doctoral dissertation are being prepared for defense.
I.V. Spichak has published more than 300 scientific works and is the author of 7 patents. Significant recognition of scientific achievements should also include international awards for innovative developments:
- Gold Medal at the International Exhibition of Innovation (Seoul, 2016);
- Bronze Medal of the All-Asia Science and Technology Innovation Exhibition (Seoul, 2016);
- Gold medal of the international exhibition "Rosbiotech" (Moscow, 2017);
- Gold medal of the international exhibition "Rosbiotech" (Moscow, 2018), etc..
I.V. Spichak is the Executive Director of the Eurasian Academy of Good Practices from 2021 to the present time
Irina Spichak is a promoter of pharmaceutical industry and professional education in the Russian Federation, a sought-after expert and speaker at professional industry platforms.
For her diligent work and achievements in professional activities, she has received numerous awards from the Ministry of Health and Social Protection of the Russian Federation and the Ministry of Education and Science of the Russian Federation. She received the Strakhov Award in the category "Education".
Tatiana Vasilyevna Nikolko
Head of FSI "SID and GP" Educational Projects of the Russian Ministry of Industry and Trade
Education: Leningrad Chemical and Pharmaceutical Institute, specialty "0809 technology of biologically active compounds"
Specialty: Chemical engineer-technologist in the specialty "0809 technology of biologically active compounds"
Length of service in the industry: 40 years
Special Achievements: Production activities - the path from Master of Pharmaceutical Production and Central Plant Laboratory Chemist to Director of Quality, Authorized Person, Pharmacovigilance Authorized Person, Advisor to the General Manager of Pharmaceutical Production.
Played one of the leading roles as quality director from the design and initial construction, commissioning, start-up, licensing and development stages of the first foreign localized pharmaceutical production facilities in Russia, such as Gedeon Richter, Hungary, KRKA, Slovenia, SERVIER, France.
Headed internal projects of companies on technological and analytical transfer with foreign and local drug manufacturers, introduction of new drugs into production. She has extensive experience in organizing and conducting work on contract manufacturing with foreign and domestic drug manufacturers.
Since 2017, she has been deputy head of the Department for Inspection of Drug Production and Expertise of the State Institute of Drugs and Good Practices of the Ministry of Industry and Trade of the Russian Federation.
Since June 2021 - head of educational projects, deputy head of the inspection body of the FBU GILS and NP, adviser to the executive director of the ANO "EANP" (Eurasian Academy of Good Practices).
Specialty: Chemical engineer-technologist in the specialty "0809 technology of biologically active compounds"
Length of service in the industry: 40 years
Special Achievements: Production activities - the path from Master of Pharmaceutical Production and Central Plant Laboratory Chemist to Director of Quality, Authorized Person, Pharmacovigilance Authorized Person, Advisor to the General Manager of Pharmaceutical Production.
Played one of the leading roles as quality director from the design and initial construction, commissioning, start-up, licensing and development stages of the first foreign localized pharmaceutical production facilities in Russia, such as Gedeon Richter, Hungary, KRKA, Slovenia, SERVIER, France.
Headed internal projects of companies on technological and analytical transfer with foreign and local drug manufacturers, introduction of new drugs into production. She has extensive experience in organizing and conducting work on contract manufacturing with foreign and domestic drug manufacturers.
Since 2017, she has been deputy head of the Department for Inspection of Drug Production and Expertise of the State Institute of Drugs and Good Practices of the Ministry of Industry and Trade of the Russian Federation.
Since June 2021 - head of educational projects, deputy head of the inspection body of the FBU GILS and NP, adviser to the executive director of the ANO "EANP" (Eurasian Academy of Good Practices).
Sysuev Boris Borisovich
Head of the Center, Professor
Doctor of Pharmaceutical Sciences, Associate Professor
Education: "Pyatigorsk State Pharmaceutical Academy"
Specialty:economist, pharmacist
Length of service in the industry: 21 year
Special Achievements: In 2012 he defended his doctoral dissertation on the specialties 14.04.01 - Technology of drugs, 14.03.06 - Pharmacology, clinical pharmacology on the topic "Technological and pharmacological studies of the mineral bischofit as a source of magnesium-containing medicines" under the guidance of scientific advisors: Head of the Department of Pharmacology, academician of RAMS, Honored Scientist of Russia Doctor of Medical Sciences, Professor AA Spasov and Doctor of Pharmaceutical Sciences, Professor E.F. Stepanova (Pyatigorsk).
Since 2002 she has been actively involved in the development and implementation of preparations based on the natural mineral bischofite. The result of this work was the development of 2 patents: "Prolonged liquid dosage form on the basis of bischofit" and "Method of bischofit purification" as well as a series of preparations for use in balneology and cosmetology on the basis of bischofit. Production of these drugs was established on the basis of training and manufacturing pharmacy in cooperation with the state institution "Volgograd Scientific Medical Center"..
Specialty:economist, pharmacist
Length of service in the industry: 21 year
Special Achievements: In 2012 he defended his doctoral dissertation on the specialties 14.04.01 - Technology of drugs, 14.03.06 - Pharmacology, clinical pharmacology on the topic "Technological and pharmacological studies of the mineral bischofit as a source of magnesium-containing medicines" under the guidance of scientific advisors: Head of the Department of Pharmacology, academician of RAMS, Honored Scientist of Russia Doctor of Medical Sciences, Professor AA Spasov and Doctor of Pharmaceutical Sciences, Professor E.F. Stepanova (Pyatigorsk).
Since 2002 she has been actively involved in the development and implementation of preparations based on the natural mineral bischofite. The result of this work was the development of 2 patents: "Prolonged liquid dosage form on the basis of bischofit" and "Method of bischofit purification" as well as a series of preparations for use in balneology and cosmetology on the basis of bischofit. Production of these drugs was established on the basis of training and manufacturing pharmacy in cooperation with the state institution "Volgograd Scientific Medical Center"..
Koshechkin Konstantin Alexandrovich
Doctor of Pharmacy, Associate Professor, Department of Information and Internet Technologies, Institute of Digital Medicine, Sechenov University
Education: I.M. Sechenov First Moscow State Medical University
Specialty:Pharmacist, Pharmacy
Length of service in the industry: 19 years
Special Achievements: 2003-2007 - Federal State Budgetary Institution "Scientific Center for Expertise of Means of Medical Use" of the Ministry of Health of Russi
2003-2010 - Trade Partnership
2007-2010 - Federal State Budgetary Institution "Scientific Center for Expertise of Means of Medical Use" of the Ministry of Health of Russia
2010-2015 - Equantics CMS
2010-2021 - Federal State Budgetary Institution "Scientific Center for Expertise of Means of Medical Use" of the Ministry of Health of Russia
Specialty:Pharmacist, Pharmacy
Length of service in the industry: 19 years
Special Achievements: 2003-2007 - Federal State Budgetary Institution "Scientific Center for Expertise of Means of Medical Use" of the Ministry of Health of Russi
2003-2010 - Trade Partnership
2007-2010 - Federal State Budgetary Institution "Scientific Center for Expertise of Means of Medical Use" of the Ministry of Health of Russia
2010-2015 - Equantics CMS
2010-2021 - Federal State Budgetary Institution "Scientific Center for Expertise of Means of Medical Use" of the Ministry of Health of Russia
Avramenko Anton Valentinovich
Head of direction of Good Manufacturing Practices
Candidate of Pharmaceutical Sciences
Education: Higher pharmaceutical, MBA
Specialty:Pharmacy
Length of service in the industry: 25 years
Special Achievements: Experience in a variety of activities covering most stages of the drug lifecycle, including training and professional association
Specialty:Pharmacy
Length of service in the industry: 25 years
Special Achievements: Experience in a variety of activities covering most stages of the drug lifecycle, including training and professional association
Kalutsky Pavel Vyacheslavovich
Doctor of Medicine, Professor
Zasova Lyubov Vladimirovna
Deputy Executive Director for Educational Activities
Ph.D. in Sociology
Vyazmina Tatyana Mikhailovna
Quality Director. R-Pharm Group of Companies
Education:
Specialty: Microbiological production engineer
Length of service in the industry: 36 years
Special Achievements: - Experience in developing and implementing a pharmaceutical quality system at the pharmaceutical companies of the group, unifying the procedures of the pharmaceutical quality system, ensuring efficiency and continuous improvement;
- Experience in implementing a strategy to implement a quality assurance system that complies with European and international standards and practices;
- Experience in auditing local and foreign sites in order to assess compliance with GMP to prepare for inspections by Russian regulatory authorities as part of licensing control, in order to certify production for compliance with ISO 9001 requirements, in order to obtain an opinion on compliance with the Good Manufacturing Practice EU (GMP EU) (obtained certificates of compliance);
- Experience in the working group of the Ministry of Industry and Trade of the Russian Federation on the development of the document of Good Manufacturing Practice (GMP) of Russia (Order 916 of the Ministry of Industry and Trade of the Russian Federation);
- Experience of inspections of reference laboratories to prepare them for accreditation for technical competence;
- Experience in the successful implementation of joint projects with European partners to localize the production of medicines on the sites of Russia;
- Experience as a member of the Working Group on the formation of common approaches to the regulation of drug circulation within the Customs Union and the Common Economic Space under the Board of the Eurasian Economic Commission.
Specialty: Microbiological production engineer
Length of service in the industry: 36 years
Special Achievements: - Experience in developing and implementing a pharmaceutical quality system at the pharmaceutical companies of the group, unifying the procedures of the pharmaceutical quality system, ensuring efficiency and continuous improvement;
- Experience in implementing a strategy to implement a quality assurance system that complies with European and international standards and practices;
- Experience in auditing local and foreign sites in order to assess compliance with GMP to prepare for inspections by Russian regulatory authorities as part of licensing control, in order to certify production for compliance with ISO 9001 requirements, in order to obtain an opinion on compliance with the Good Manufacturing Practice EU (GMP EU) (obtained certificates of compliance);
- Experience in the working group of the Ministry of Industry and Trade of the Russian Federation on the development of the document of Good Manufacturing Practice (GMP) of Russia (Order 916 of the Ministry of Industry and Trade of the Russian Federation);
- Experience of inspections of reference laboratories to prepare them for accreditation for technical competence;
- Experience in the successful implementation of joint projects with European partners to localize the production of medicines on the sites of Russia;
- Experience as a member of the Working Group on the formation of common approaches to the regulation of drug circulation within the Customs Union and the Common Economic Space under the Board of the Eurasian Economic Commission.
Kovrigin Alexei Alexandrovich
Director of Licensing and Good Practice Verification at Valenta Pharma JSC
Education: 2000 - 2007 Kursk State Medical University
2015-2016 Moscow Institute of Physics and Technology (State University)
2021 Collective Use Center (Scientific and Educational Center) of the PFUR
Specialty: Biotechnology qualification engineer
Length of service in the industry: Over 14 years
Special Achievements: Worked in well-known Russian pharmaceutical companies Sotex, Pharmstandard OJSC, Petrovaks Farm NPO LLC in engineering and management positions.
Has been involved in the scaling and porting of drug technology, mainly aseptic pharmaceuticals. Experienced in passing audits by partners (Pfizer, Roche, Johnson&Johnson, Nic, Boehringer Ingelheim, Grindex, Eli Lilly) within the framework of drug localization in the Russian Federation.
Was engaged in preparation of production sites and support of license inspections/GMP audits (GMP conclusions of the Ministry of Industry and Trade of Russia, Rosselkhoznadzor of Russia, Republic of Slovakia, Islamic Republic of Iran, Cuba, Republic of Belarus, Kazakhstan, Ukraine, etc.), as well as audits of partners.
In 2015 - 2016 he worked as a Leading Advisor of the Department of Licensing of Production of Medicines of the Department of Pharmaceutical and Medical Industry Development of the Ministry of Industry and Trade of the Russian Federation, where he participated in activities and inspections related to establishing compliance and fulfillment of license requirements in the production of medicines, participation in activities related to the granting of licenses, re-licensing, as well as the development of regulatory legal acts.
Since 2017 she has been working at Valenta Pharm JSC. Currently holds the position of Director of Licensing and Compliance Assurance of Good Practices.
The main tasks in the Company are:
• Organization and implementation of independent monitoring of compliance with license and legal requirements at the enterprise in the production of drugs, storage and distribution, work with precursors and potent drugs (passed scheduled and unscheduled field inspections of the Ministry of Industry and Trade of Russia, Roszdravnadzor, Rospotrebnadzor without fines and sanctions, obtained certificates of GMP RF and EAEC of the Ministry of Industry and Trade of Russia).
• Preparation of foreign production sites for inspections of Mipnromtorg of Russia (preparation of a set of documents, pre-audit of the production site, audit support, work on compilation and preparation of the inspection report). Received GMP conclusions for production sites located in India, Italy, Turkey, South Korea.
• Independent expertise/audit of potential Partners' production sites for compliance with legal requirements of the Russian Federation/Eurasian Economic Union.
• Interaction with supervisory authorities on issues related to licensing of activities, obtaining GMP approvals and compliance with legal requirements in the field of drug circulation.
2015-2016 Moscow Institute of Physics and Technology (State University)
2021 Collective Use Center (Scientific and Educational Center) of the PFUR
Specialty: Biotechnology qualification engineer
Length of service in the industry: Over 14 years
Special Achievements: Worked in well-known Russian pharmaceutical companies Sotex, Pharmstandard OJSC, Petrovaks Farm NPO LLC in engineering and management positions.
Has been involved in the scaling and porting of drug technology, mainly aseptic pharmaceuticals. Experienced in passing audits by partners (Pfizer, Roche, Johnson&Johnson, Nic, Boehringer Ingelheim, Grindex, Eli Lilly) within the framework of drug localization in the Russian Federation.
Was engaged in preparation of production sites and support of license inspections/GMP audits (GMP conclusions of the Ministry of Industry and Trade of Russia, Rosselkhoznadzor of Russia, Republic of Slovakia, Islamic Republic of Iran, Cuba, Republic of Belarus, Kazakhstan, Ukraine, etc.), as well as audits of partners.
In 2015 - 2016 he worked as a Leading Advisor of the Department of Licensing of Production of Medicines of the Department of Pharmaceutical and Medical Industry Development of the Ministry of Industry and Trade of the Russian Federation, where he participated in activities and inspections related to establishing compliance and fulfillment of license requirements in the production of medicines, participation in activities related to the granting of licenses, re-licensing, as well as the development of regulatory legal acts.
Since 2017 she has been working at Valenta Pharm JSC. Currently holds the position of Director of Licensing and Compliance Assurance of Good Practices.
The main tasks in the Company are:
• Organization and implementation of independent monitoring of compliance with license and legal requirements at the enterprise in the production of drugs, storage and distribution, work with precursors and potent drugs (passed scheduled and unscheduled field inspections of the Ministry of Industry and Trade of Russia, Roszdravnadzor, Rospotrebnadzor without fines and sanctions, obtained certificates of GMP RF and EAEC of the Ministry of Industry and Trade of Russia).
• Preparation of foreign production sites for inspections of Mipnromtorg of Russia (preparation of a set of documents, pre-audit of the production site, audit support, work on compilation and preparation of the inspection report). Received GMP conclusions for production sites located in India, Italy, Turkey, South Korea.
• Independent expertise/audit of potential Partners' production sites for compliance with legal requirements of the Russian Federation/Eurasian Economic Union.
• Interaction with supervisory authorities on issues related to licensing of activities, obtaining GMP approvals and compliance with legal requirements in the field of drug circulation.
Zelinskaya Elena Valerievna
Quality Director of FARMA CAPITAL LLC
Education:
Specialty:
Length of service in the industry: Over 15 years
Special Achievements: Member of ECA Academy. Speaker of international conferences. Member of the Roszdravnadzor working group on the formation of regulatory acts in the field of RFP circulation and the working group of the Subcommittee on drug circulation, pharmaceutical and medical industry development of the State Duma Committee on Health Protection.
Specialty:
Length of service in the industry: Over 15 years
Special Achievements: Member of ECA Academy. Speaker of international conferences. Member of the Roszdravnadzor working group on the formation of regulatory acts in the field of RFP circulation and the working group of the Subcommittee on drug circulation, pharmaceutical and medical industry development of the State Duma Committee on Health Protection.
Arantseva Diana Alexandrovna
Head of the Laboratory of Parenteral Drug Formulations and Delivery Systems of the Center for Pharmaceutical Development and Innovative Drug Formulations at Sechenov University
Vasiliev Vasily Igorevich
Head of the Computerized Systems Validation Group of the Quality Directorate
Ph.D. in Physics and Mathematics R-Pharm JSC
Education: Institute of Physics of the National Academy of Sciences of Ukraine
Specialty:
Length of service in the industry:
Special Achievements: - Author of FSI "SID and GP"/Pharmstrategy training seminar "Risk-Based Approach to Validation of Computerized Systems
- ISPE Membership
Specialty:
Length of service in the industry:
Special Achievements: - Author of FSI "SID and GP"/Pharmstrategy training seminar "Risk-Based Approach to Validation of Computerized Systems
- ISPE Membership
Guzevatykh Lyudmila Sergeevna
Head of GMP Process Toxicology Group of R-Pharm Group
Doctor of Biological Sciences
Education:
Specialty: Physiology
Length of service in the industry: Over 25 years
Special Achievements: R&D, DCI, CI, registration, production (quality management)
Specialty: Physiology
Length of service in the industry: Over 25 years
Special Achievements: R&D, DCI, CI, registration, production (quality management)
Belinsky Alexander Grigoryevich
Validation Team Leader
Education:
Specialty: Biotechnological Engineer
Length of service in the industry: 16 years
Special Achievements:
Specialty: Biotechnological Engineer
Length of service in the industry: 16 years
Special Achievements:
Golobokova Margarita Valerievna
Manager of sterility assurance
Education:
Specialty:Teacher of Biology and Chemistry
Length of service in the industry: 8 years
Special Achievements: 2008-2014 biologist at the Center for Hygiene and Epidemiology
2014-2017 microbiologist
Specialty:Teacher of Biology and Chemistry
Length of service in the industry: 8 years
Special Achievements: 2008-2014 biologist at the Center for Hygiene and Epidemiology
2014-2017 microbiologist
Yuri Sandler
Regional Director and Chief Data Integrity Consultant at PQE CIS (PQE Group), Moscow, Russia
Education: 2007-2011 - Biomedical Engineer (B.Sc.) Ben-Gurion University, Israel.
2017 - Project Management Course, PQE Group - Italy
Specialty:
Length of service in the industry:
Special Achievements: Six years of experience in opening, developing and managing local branches in Russia and Israel
Ten years of experience in project and personnel management
Inter-organizational and interdisciplinary project management
Eight years of experience managing and executing data integrity projects for pharmaceutical companies and medical device manufacturers around the world
Skills in individual work as well as work in a team or work group. Excellent interpersonal communication and high adaptability
Extensive knowledge in building pharmaceutical company QMS
Membership in ISPE since 2018.
2017 - Project Management Course, PQE Group - Italy
Specialty:
Length of service in the industry:
Special Achievements: Six years of experience in opening, developing and managing local branches in Russia and Israel
Ten years of experience in project and personnel management
Inter-organizational and interdisciplinary project management
Eight years of experience managing and executing data integrity projects for pharmaceutical companies and medical device manufacturers around the world
Skills in individual work as well as work in a team or work group. Excellent interpersonal communication and high adaptability
Extensive knowledge in building pharmaceutical company QMS
Membership in ISPE since 2018.
Sepp Vladislav Valentinovich
Associate Professor, Department of Pharmacy, N.I. Pirogov Russian National Research Medical University
Candidate of Pharmaceutical Sciences, Associate Professor
Education:
Specialty:Pharmacist (Pharmacy)
Length of service in the industry: 14 years
Special Achievements: N.I. Pirogov Russian National Research Medical University
Smolensk State Medical Academy
International drug manufacturing companies
Specialty:Pharmacist (Pharmacy)
Length of service in the industry: 14 years
Special Achievements: N.I. Pirogov Russian National Research Medical University
Smolensk State Medical Academy
International drug manufacturing companies
Zhilin Alexei Vladimirovich
Academy instructor
Education: St. Petersburg Chemical and Pharmaceutical Academy
Specialty:Biotechnology
Length of service in the industry: Over 19 years
Special Achievements: Until May 2022 - Head of Training and Development of the Pharmaceutical Inspectorate of FSI "SID and GP"
Specialty:Biotechnology
Length of service in the industry: Over 19 years
Special Achievements: Until May 2022 - Head of Training and Development of the Pharmaceutical Inspectorate of FSI "SID and GP"
Spitsky Oleg Rozumbaevich
Specialist of Engineering and Design Department of FSI "SID and GP", expert.
Education:
Specialty:
Length of service in the industry:
Special Achievements: Has more than 30 years of experience in the pharmaceutical industry in technology development, pharmaceutical manufacturing, pharmaceutical engineering, quality control and quality assurance, specializing in solid dosage forms, liquid non-sterile and sterile forms (including aseptic manufacturing), immunobiological and biotechnological preparations.
Specialty:
Length of service in the industry:
Special Achievements: Has more than 30 years of experience in the pharmaceutical industry in technology development, pharmaceutical manufacturing, pharmaceutical engineering, quality control and quality assurance, specializing in solid dosage forms, liquid non-sterile and sterile forms (including aseptic manufacturing), immunobiological and biotechnological preparations.
Tolkushin Alexander Gennadievich
Head of the Scientific Center for Access to Medicines, Eurasian Academy of Good Practices, General Director of the Pro Consilium Rational Justification Center LLC, PhD in Pharmacy.
Education:
Specialty:
Length of service in the industry:
Special Achievements:
Specialty:
Length of service in the industry:
Special Achievements:
Futysh Kirill Bogdanovich
Deputy Head of the Validation Department of Generium JSC for Production Development
Shokhin Igor Yevgenyevich
General Director of the Center for Pharmaceutical Analytics.
Doctor of Pharmaceutical Sciences
Education:
Specialty:
Length of service in the industry:
Special Achievements: • Topic of doctoral dissertation "Methodological foundations of in vitro equivalence studies and modeling of drug release in the gastrointestinal tract". • More than 150 scientific publications, 15 in foreign peer-reviewed journals, 6 methodological recommendations, 3 monographs, Hirsch index 10.
• Lead translator and scientific editor of the Russian edition of the European Pharmacopoeia.
• Irreplaceable chairman of the organizing committee of the conference series "Drug Development and Registration"
• Editor-in-Chief of the Scientific and Production Journal "Development and Registration of Medicines"
• Author of the monograph "The Dissolution Test in Drug Development and Registration"
• Expert of the Russian Science Foundation
• Supervisor of more than 250 bioanalytical studies (2011-2021)
Specialty:
Length of service in the industry:
Special Achievements: • Topic of doctoral dissertation "Methodological foundations of in vitro equivalence studies and modeling of drug release in the gastrointestinal tract". • More than 150 scientific publications, 15 in foreign peer-reviewed journals, 6 methodological recommendations, 3 monographs, Hirsch index 10.
• Lead translator and scientific editor of the Russian edition of the European Pharmacopoeia.
• Irreplaceable chairman of the organizing committee of the conference series "Drug Development and Registration"
• Editor-in-Chief of the Scientific and Production Journal "Development and Registration of Medicines"
• Author of the monograph "The Dissolution Test in Drug Development and Registration"
• Expert of the Russian Science Foundation
• Supervisor of more than 250 bioanalytical studies (2011-2021)
Romodanovsky Dmitry Pavlovich
Specialist in the development and registration of medicines for medical use at the Scientific Consulting Center LLC
Doctor of Medicine
Education: Moscow State University of Medicine and Dentistry named after A.I. Evdokimov. A.I. Evdokimov Moscow State Medical and Dental University
Specialty: Medical Business
Length of service in the industry: 14 лет
Special Achievements: From 2007, he worked as a state expert at the Russian Ministry of Health's Scientific Center for Expertise of Medical Devices.
Since 2021, she has been an employee of the Scientific Consulting Center, LLC.
Specialty: Medical Business
Length of service in the industry: 14 лет
Special Achievements: From 2007, he worked as a state expert at the Russian Ministry of Health's Scientific Center for Expertise of Medical Devices.
Since 2021, she has been an employee of the Scientific Consulting Center, LLC.
Dranitsina Margarita Alexandrovna
Regulatory Affairs and Drug Development Specialist at Center for Scientific Advice, LLC
Candidate of Medical Sciences
Education: Moscow State Medical University. A.I. Evdokimov Moscow State Medical University
Specialty: Medical Business
Length of service in the industry: 14 years
Special Achievements: In 2007-2009, underwent residency in dermatovenerology.
Graduated from Lomonosov Moscow State University in 2009. In 2009 she graduated from Lomonosov Moscow State University with a degree in mathematics and systems programming.
In 2012, she received a certificate in dermatovenerology.
In 2006-2009, she worked at the publishing house of medical literature "GEOTAR".
In 2009-2011 she worked at Elsevier publishing house. In 2012-2014, she worked at MedWeb, a medical education platform.
In 2014-2016, she was a state expert at the Federal State Budgetary Institution "Scientific Center for Expertise of Means of Medical Use of the Ministry of Health of the Russian Federation of the Ministry of Health of Russia".
Since 2016, a specialist in drug development for medical use and biostatistics at the Center for Scientific Advice LLC, co-founded by.
Specialty: Medical Business
Length of service in the industry: 14 years
Special Achievements: In 2007-2009, underwent residency in dermatovenerology.
Graduated from Lomonosov Moscow State University in 2009. In 2009 she graduated from Lomonosov Moscow State University with a degree in mathematics and systems programming.
In 2012, she received a certificate in dermatovenerology.
In 2006-2009, she worked at the publishing house of medical literature "GEOTAR".
In 2009-2011 she worked at Elsevier publishing house. In 2012-2014, she worked at MedWeb, a medical education platform.
In 2014-2016, she was a state expert at the Federal State Budgetary Institution "Scientific Center for Expertise of Means of Medical Use of the Ministry of Health of the Russian Federation of the Ministry of Health of Russia".
Since 2016, a specialist in drug development for medical use and biostatistics at the Center for Scientific Advice LLC, co-founded by.
Shestakova Anastasia Konstantinovna
Chief Specialist of the Scientific-Expert Center for Drug Development and Registration
Mashutin Alexander Borisovich
Specialist in the development and registration of medicines for medical use
Candidate of Pharmaceutical Sciences
Education: I.M. Sechenov Moscow Medical Academy.
Specialty:Pharmacy
Length of service in the industry: 27 years
Special Achievements: In drug development since 1995, including research organizations (State Scientific Center for Applied Microbiology, Research Institute of Pharmacology named after V.V. Zakusov), consulting in drug registration (Deputy Director of Medical and Pharmaceutical Department of ANO "Expert Legal Center for Medicines and Medicinal Products"), foreign and domestic manufacturing companies (Deputy Medical Director of the Representative Office of Unifarm Inc. "(CWA), Director of Research and Development at PROMOMED Group), expert organizations (Deputy Director of the Institute for Drug Quality Expertise at the National Center for Medicinal Products Expertise of the Russian Ministry of Health), has held federal civil service at the Ministry of Health of the Russian Federation. Currently Director of Regulatory Affairs at Kinetik-Pharm LLC.
Specialty:Pharmacy
Length of service in the industry: 27 years
Special Achievements: In drug development since 1995, including research organizations (State Scientific Center for Applied Microbiology, Research Institute of Pharmacology named after V.V. Zakusov), consulting in drug registration (Deputy Director of Medical and Pharmaceutical Department of ANO "Expert Legal Center for Medicines and Medicinal Products"), foreign and domestic manufacturing companies (Deputy Medical Director of the Representative Office of Unifarm Inc. "(CWA), Director of Research and Development at PROMOMED Group), expert organizations (Deputy Director of the Institute for Drug Quality Expertise at the National Center for Medicinal Products Expertise of the Russian Ministry of Health), has held federal civil service at the Ministry of Health of the Russian Federation. Currently Director of Regulatory Affairs at Kinetik-Pharm LLC.
Gavrishina Elena Valeryevna
Head of Original Medicines Department
Candidate of Medical Sciences
Education: Moscow Medical Academy. I.M. Sechenov
Specialty: Medicine, Pharmacology
Length of service in the industry: 26 years
Special Achievements: In 1995-1996, she completed an internship in therapy..
In 2003, she received a certificate in clinical pharmacology.
From 2000 to 2016, she worked at the Federal State Budgetary Institution "Scientific Center for Expertise of Means of Medical Use of the Ministry of Health of the Russian Federation of the Ministry of Health of Russia" in various positions, since 2010. - As a state expert.
From 1996 to 2014, she worked part-time at the Department of Clinical Pharmacology and Propaedeutics of Internal Medicine of the First Sechenov Moscow State Medical University.
Since 2016, a specialist in the development and registration of drugs for medical use at the Center for Scientific Advice LLC, co-founded by.
Specialty: Medicine, Pharmacology
Length of service in the industry: 26 years
Special Achievements: In 1995-1996, she completed an internship in therapy..
In 2003, she received a certificate in clinical pharmacology.
From 2000 to 2016, she worked at the Federal State Budgetary Institution "Scientific Center for Expertise of Means of Medical Use of the Ministry of Health of the Russian Federation of the Ministry of Health of Russia" in various positions, since 2010. - As a state expert.
From 1996 to 2014, she worked part-time at the Department of Clinical Pharmacology and Propaedeutics of Internal Medicine of the First Sechenov Moscow State Medical University.
Since 2016, a specialist in the development and registration of drugs for medical use at the Center for Scientific Advice LLC, co-founded by.
Astafiev Sergey Vyacheslavovich
General Director of Way of Good Practices LLC
Education: G.V. Plekhanov Russian University of Economics
Specialty: Management
Length of service in the industry: 7 years
Special Achievements: Developer of unique methodologies for object qualification and process validation. The document is the basic basis for almost all Russian companies that are engaged in mapping pharmaceutical warehouses
Specialty: Management
Length of service in the industry: 7 years
Special Achievements: Developer of unique methodologies for object qualification and process validation. The document is the basic basis for almost all Russian companies that are engaged in mapping pharmaceutical warehouses
Kukharenko Andrei Vadimovich
Development Director, Cold Chain Technologies Group
Ph.D. in Economics
Education: Higher education
Specialty: Economics and management at the enterprise
Length of service in the industry: 15 years
Specialty: Economics and management at the enterprise
Length of service in the industry: 15 years
Spichak Irina Vladimirovna
Executive Director of the Eurasian Academy of Good Practices
Doctor of Pharmaceutical Sciences, Professor
Education: - Kursk State Medical Institute, Faculty of Pharmacy, diploma with honors, qualification - pharmacist;
-St. Petersburg University of Engineering and Economics, Department of Economics and Management, qualification - economic manager;
- "Moscow Institute of Steel and Alloys" - Quality Management;
- High school teacher.
Honors: 1993 - Degree of Candidate of Pharmaceutical Sciences (All-Union Scientific Research Institute of Pharmacy, Moscow);
2002 - Received the title of associate professor;
2004 - Doctor of Pharmaceutical Sciences (PFUR, Moscow);
2010 - Received the title of professor
Length of service in the industry: The total experience of pedagogical work in the industry is 33 years. During this period she will go from graduate student to head of department, dean of faculty and director of the institute
Special Achievements: • Head of the pilot innovative project of the Ministry of Health of the Russian Federation "Formation of the quality system of education in higher medical education institutions", which was successfully implemented and became the methodological basis for the formation of quality systems of education in universities of the Russian Federation (2003).;
• Open University Tutor, UK (International Institute of Management LINK);
• Expert of the All-Russian Public Organization "Medical League of Russia" (accreditation of educational activities of medical universities in Russia);
• Expert of the Ministry of Education and Science of the Russian Federation (accreditation of educational activities of Russian universities);
• Member of the Russian Ministry of Education and Science's Department of Medical and Pharmaceutical Education;
• Member of the Coordinating Council for the Development of Continuing Medical and Pharmaceutical Education of the Ministry of Health of the Russian Federation;
• Member of the working group of the Ministry of Education and the Ministry of Health under the President of Russia on professional competencies;
• Member of the Dissertation Council on Pharmacy at Sechenov Moscow State Medical University (Moscow);
• Member of the editorial board of 3 scientific journals, etc.
He is the author of more than 50 educational and methodical publications, 2 textbooks recommended by the Federal Educational-Methodical Association for students of universities studying in the specialty "Pharmacy", as well as 4 monographs..
Within the framework of the scientific school under the leadership of Spichak I.V. 6 candidate dissertations were defended, 3 candidate dissertations and one doctoral dissertation are being prepared for defense.
I.V. Spichak has published more than 300 scientific works and is the author of 7 patents. Significant recognition of scientific achievements should also include international awards for innovative developments:
- Gold Medal at the International Exhibition of Innovation (Seoul, 2016);
- Bronze Medal of the All-Asia Science and Technology Innovation Exhibition (Seoul, 2016);
- Gold medal of the international exhibition "Rosbiotech" (Moscow, 2017);
- Gold medal of the international exhibition "Rosbiotech" (Moscow, 2018), etc..
I.V. Spichak is the Executive Director of the Eurasian Academy of Good Practices from 2021 to the present time
Irina Spichak is a promoter of pharmaceutical industry and professional education in the Russian Federation, a sought-after expert and speaker at professional industry platforms.
For her diligent work and achievements in professional activities, she has received numerous awards from the Ministry of Health and Social Protection of the Russian Federation and the Ministry of Education and Science of the Russian Federation. She received the Strakhov Award in the category "Education".
-St. Petersburg University of Engineering and Economics, Department of Economics and Management, qualification - economic manager;
- "Moscow Institute of Steel and Alloys" - Quality Management;
- High school teacher.
Honors: 1993 - Degree of Candidate of Pharmaceutical Sciences (All-Union Scientific Research Institute of Pharmacy, Moscow);
2002 - Received the title of associate professor;
2004 - Doctor of Pharmaceutical Sciences (PFUR, Moscow);
2010 - Received the title of professor
Length of service in the industry: The total experience of pedagogical work in the industry is 33 years. During this period she will go from graduate student to head of department, dean of faculty and director of the institute
Special Achievements: • Head of the pilot innovative project of the Ministry of Health of the Russian Federation "Formation of the quality system of education in higher medical education institutions", which was successfully implemented and became the methodological basis for the formation of quality systems of education in universities of the Russian Federation (2003).;
• Open University Tutor, UK (International Institute of Management LINK);
• Expert of the All-Russian Public Organization "Medical League of Russia" (accreditation of educational activities of medical universities in Russia);
• Expert of the Ministry of Education and Science of the Russian Federation (accreditation of educational activities of Russian universities);
• Member of the Russian Ministry of Education and Science's Department of Medical and Pharmaceutical Education;
• Member of the Coordinating Council for the Development of Continuing Medical and Pharmaceutical Education of the Ministry of Health of the Russian Federation;
• Member of the working group of the Ministry of Education and the Ministry of Health under the President of Russia on professional competencies;
• Member of the Dissertation Council on Pharmacy at Sechenov Moscow State Medical University (Moscow);
• Member of the editorial board of 3 scientific journals, etc.
He is the author of more than 50 educational and methodical publications, 2 textbooks recommended by the Federal Educational-Methodical Association for students of universities studying in the specialty "Pharmacy", as well as 4 monographs..
Within the framework of the scientific school under the leadership of Spichak I.V. 6 candidate dissertations were defended, 3 candidate dissertations and one doctoral dissertation are being prepared for defense.
I.V. Spichak has published more than 300 scientific works and is the author of 7 patents. Significant recognition of scientific achievements should also include international awards for innovative developments:
- Gold Medal at the International Exhibition of Innovation (Seoul, 2016);
- Bronze Medal of the All-Asia Science and Technology Innovation Exhibition (Seoul, 2016);
- Gold medal of the international exhibition "Rosbiotech" (Moscow, 2017);
- Gold medal of the international exhibition "Rosbiotech" (Moscow, 2018), etc..
I.V. Spichak is the Executive Director of the Eurasian Academy of Good Practices from 2021 to the present time
Irina Spichak is a promoter of pharmaceutical industry and professional education in the Russian Federation, a sought-after expert and speaker at professional industry platforms.
For her diligent work and achievements in professional activities, she has received numerous awards from the Ministry of Health and Social Protection of the Russian Federation and the Ministry of Education and Science of the Russian Federation. She received the Strakhov Award in the category "Education".
Kalutsky Pavel Vyacheslavovich
Doctor of Medicine, Professor
Zasova Lyubov Vladimirovna
Deputy Executive Director for Educational Activities
Ph.D. in Sociology
Avramenko Anton Valentinovich
Head of Good Manufacturing Practices
Candidate of Pharmaceutical Sciences
Mikhailov Ivan Vladimirovich
Head of the Educational and Methodological Center
Mishukov Denis Sergeyevich
Leading Specialist of the Educational and Methodological Center
Zvyagintseva Angelina Vladimirovna
Leading Specialist of the Educational and Methodological Center
Guseva Anna Vladimirovna
Head of External Communications
Spichak Alena Sergeyevna
Chief Specialist of Marketing Department
Kiseleva Tatyana Vladimirovna
Chief Accountant
Gubaidullina Dilyara Makhmudovna
Head of Partners and Counterparties
Varlashkina Anastasia Alexeyevna
Assistant Executive Director