26.06.2024
16:45–18:15
Legal Regulation of the Introduction of Healthcare Innovations
Congress Centre, conference hall D4
Russia needs to create its own critical technologies or take them to a new level, including the manufacturing of drugs. Developing this key segment is crucial to ensuring the country’s technological sovereignty. In this regard, the issue of regulatory support for innovations related to the healthcare system takes on added importance. One of the main goals in this regard is to increase the efficiency, volume, types, and quality of medical services in line with the needs of the population as well as the advanced achievements being made in medical science. Often, the direct incorporation of new technologies into practice is hampered by the insufficient flexibility of the regulatory system. This leads to difficulties both in terms of the development of and ensuring subsequent access to drugs and, as a result, the significant limitation of patients’ ability to receive modern, high-quality medical care. Issues concerning regulatory support are important for innovations related to digital technologies, additive technologies, biomedical cell products, molecular genetic research, and much more. In this regard, it is crucial to pay attention to and discuss ways to draft legislation on issues related to the development of such medical technologies, as well as approaches to their inclusion in the public funding system and ensuring their effective use. What legal norms are currently limiting factors and which ones will create the conditions needed to develop and introduce innovative technologies in the clinical practice of Russian healthcare? What are the risks of introducing artificial intelligence into healthcare? What financial opportunities exist for artificial intelligence in healthcare? What mechanisms could be proposed to take into account the absence or insufficiency of data needed to adopt a decision on funding? Are doctors and the healthcare system ready to use innovative medical technologies?
Moderator
Anna Solovieva-Oposhnyanskaya
Expert, Institute for National and Comparative Law Studies, Faculty of Law, National Research University Higher School of Economics
Speakers
Albina Gadzhieva
Deputy Dean, Faculty of Law; Director, Institute for National and Comparative Law Research, National Research University Higher School of Economics
Dmitry Galkin
Director of Department of Pharmaceutical and Medical Industry Development, Ministry of Industry and Trade of the Russian Federation (online)
Valentin Dodonov
Director of the Market Access Department, BIOCAD Joint Stock Company
Yulia Ilyinova
Vice Rector for Academic Affairs, Saint-Petersburg State Chemical and Pharmaceutical University
Aleksey Kedrin
Chairman of the Board, Association of Pharmaceutical Manufacturers of the Eurasian Economic Union (EAEU)
Igor Korobko
Head of Science and Innovative Development of Health Department, Ministry of Health of the Russian Federation (online)
Valentina Kosenko
General Director, Scientific Center for Expertise of Medicinal Products of the Ministry of the Ministry of Health of the Russian Federation (online)
Vitaliy Omelyanovskiy
General Director, Center for Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation
Nadezhda Rukavitsyna
Head of the Center for Support of Innovation Implementation, Center for Expertise and Quality Control of Medical Care of the Ministry of Health of the Russian Federation
Vaseliy Ryazhenov
Head of the Department of Regulatory Relations in the Field of Circulation of Medicines and Medical Devices, First Moscow State Medical University named after I.M. Sechenov of the Ministry of Health of the Russian Federation
Front row participant
Svetlana Solovyova
Assistant to the Minister of Health of the Russian Federation (online)
Broadcast

Anna Solovieva-Oposhnyanskaya
Expert, Institute for National and Comparative Law Studies, Faculty of Law, National Research University Higher School of Economics

Albina Gadzhieva
Deputy Dean, Faculty of Law; Director, Institute for National and Comparative Law Research, National Research University Higher School of Economics

Dmitry Galkin
Director of Department of Pharmaceutical and Medical Industry Development, Ministry of Industry and Trade of the Russian Federation

Valentin Dodonov
Director of the Market Access Department, BIOCAD Joint Stock Company

Yulia Ilyinova
Vice Rector for Academic Affairs, Saint-Petersburg State Chemical and Pharmaceutical University

Aleksey Kedrin
Chairman of the Board, Association of Pharmaceutical Manufacturers of the Eurasian Economic Union (EAEU)
Alexey Leonidovich Kedrin was born on September 28, 1966 in Onega, Arkhangelsk region. After graduating from the Faculty of Journalism of Leningrad State University, Alexey worked in the field of public relations in Saint-Petersburg City Administration. After that, Alexey held senior positions in Russian Presidential Academy of National Economy and Public Administration under the President of the Russian Federation and in FMCG market companies.
Today Alexey is the Chairman of the Board of the Association of Pharmaceutical Manufacturers of the Eurasian Economic Union. Since 2022 - holds the position of Chairman of the Board of the Association of Pharmaceutical Manufacturers of the EAEU.
Today Alexey is the Chairman of the Board of the Association of Pharmaceutical Manufacturers of the Eurasian Economic Union. Since 2022 - holds the position of Chairman of the Board of the Association of Pharmaceutical Manufacturers of the EAEU.

Igor Korobko
Head of Science and Innovative Development of Health Department, Ministry of Health of the Russian Federation

Valentina Kosenko
General Director, Scientific Center for Expertise of Medicinal Products of the Ministry of the Ministry of Health of the Russian Federation

Vitaliy Omelyanovskiy
General Director, Center for Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation
Born July 27, 1964 in Obninsk, Kaluga Oblast.
In 1987, he graduated from the Pirogov Russian National Research Medical University with a degree in General Medicine. After graduation he stayed in the university, where he rose from postgraduate to professor of the department of clinical pharmacology.
In 1998 he graduated from the Russian Presidential Academy of National Economy and Public Administration of the Russian Federation with a degree in state and municipal management, with the qualification of economist-financier.
In 2002, he defended the first doctoral dissertation in the Russian Federation on clinical and economic analysis and pharmacoeconomics.
From 2009 to 2012 he was. - Vladimir Potanin was Director of the Research Institute for Clinical and Economic Expertise and Pharmacoeconomics at the N.I. Pirogov Russian National Research Medical University, Federal State Autonomous Educational Institution of Higher Professional Education, Ministry of Health Care of the Russian Federation.
From 2012 to 2020, she was Head of the Research Laboratory of the N.I. Pirogov Russian National Research Medical University. - Head of the Research Laboratory for Technology Assessment in Healthcare at the Institute of Applied Economic Research of the Russian Presidential Academy of National Economy and Public Administration, a federal state budget-funded educational institution of higher education.
Since 2014. - Head of the Healthcare Finance Center of the Federal State Budgetary Institution "Research Financial Institute" of the Ministry of Finance of the Russian Federation. Ministry of Finance of the Russian Federation.
Since 2015. - General Director of the Federal State Budgetary Institution "Center for Expertise and Quality Control of Medical Care" of the Ministry of Health of the Russian Federation.
Since 2020. - Head of the Department of Economics, Management and Assessment of Healthcare Technologies of the Federal State Budgetary Educational Institution of Additional Professional Education "Russian Medical Academy of Continuing Professional Education" of the Ministry of Healthcare of the Russian Federation.
Member of the Dissertation Council D 208.088.01.
Head of the Expert Council on Health Care of the Federation Council Committee on Social Policy, Expert of the Analytical Centre for the Government of the Russian Federation.
Chief Clinical Pharmacologist, Ministry of Health, Moscow Region.
Chief editor of scientific journals, Pharmacoeconomics. Modern Pharmacoeconomics and Pharmacoepidemiology" and "Medical Technology. Evaluation and Choice".
She is an author of three patents of the Russian Federation, two monographs, educational and methodical manuals for physicians, and more than 140 scientific papers published in Russian and foreign medical journals.
Doctor of Medicine (2002), Professor (2007). Under his supervision V.V. Omelyanovsky defended one doctoral thesis and seven Ph. Currently supervises the theses of two doctoral students and two doctoral candidates.
He is the President of the Russian branch of the International Society for Pharmacoeconomic Research and Outcome Evaluation (ISPOR).
He is a laureate of the Russian Federation Government Award in Science and Technology, has certificates of merit from the President of the Russian Federation and the Chairman of the Federation Council of the Federal Assembly of the Russian Federation, and has received commendations from the Chairman of the Federation Council of the Federal Assembly of the Russian Federation, the Analytical Center of the Russian Federation Government, the Russian Academy of National Economy and Public Administration under the President of the Russian Federation, and the Sverdlovsk Oblast Government.
In 1987, he graduated from the Pirogov Russian National Research Medical University with a degree in General Medicine. After graduation he stayed in the university, where he rose from postgraduate to professor of the department of clinical pharmacology.
In 1998 he graduated from the Russian Presidential Academy of National Economy and Public Administration of the Russian Federation with a degree in state and municipal management, with the qualification of economist-financier.
In 2002, he defended the first doctoral dissertation in the Russian Federation on clinical and economic analysis and pharmacoeconomics.
From 2009 to 2012 he was. - Vladimir Potanin was Director of the Research Institute for Clinical and Economic Expertise and Pharmacoeconomics at the N.I. Pirogov Russian National Research Medical University, Federal State Autonomous Educational Institution of Higher Professional Education, Ministry of Health Care of the Russian Federation.
From 2012 to 2020, she was Head of the Research Laboratory of the N.I. Pirogov Russian National Research Medical University. - Head of the Research Laboratory for Technology Assessment in Healthcare at the Institute of Applied Economic Research of the Russian Presidential Academy of National Economy and Public Administration, a federal state budget-funded educational institution of higher education.
Since 2014. - Head of the Healthcare Finance Center of the Federal State Budgetary Institution "Research Financial Institute" of the Ministry of Finance of the Russian Federation. Ministry of Finance of the Russian Federation.
Since 2015. - General Director of the Federal State Budgetary Institution "Center for Expertise and Quality Control of Medical Care" of the Ministry of Health of the Russian Federation.
Since 2020. - Head of the Department of Economics, Management and Assessment of Healthcare Technologies of the Federal State Budgetary Educational Institution of Additional Professional Education "Russian Medical Academy of Continuing Professional Education" of the Ministry of Healthcare of the Russian Federation.
Member of the Dissertation Council D 208.088.01.
Head of the Expert Council on Health Care of the Federation Council Committee on Social Policy, Expert of the Analytical Centre for the Government of the Russian Federation.
Chief Clinical Pharmacologist, Ministry of Health, Moscow Region.
Chief editor of scientific journals, Pharmacoeconomics. Modern Pharmacoeconomics and Pharmacoepidemiology" and "Medical Technology. Evaluation and Choice".
She is an author of three patents of the Russian Federation, two monographs, educational and methodical manuals for physicians, and more than 140 scientific papers published in Russian and foreign medical journals.
Doctor of Medicine (2002), Professor (2007). Under his supervision V.V. Omelyanovsky defended one doctoral thesis and seven Ph. Currently supervises the theses of two doctoral students and two doctoral candidates.
He is the President of the Russian branch of the International Society for Pharmacoeconomic Research and Outcome Evaluation (ISPOR).
He is a laureate of the Russian Federation Government Award in Science and Technology, has certificates of merit from the President of the Russian Federation and the Chairman of the Federation Council of the Federal Assembly of the Russian Federation, and has received commendations from the Chairman of the Federation Council of the Federal Assembly of the Russian Federation, the Analytical Center of the Russian Federation Government, the Russian Academy of National Economy and Public Administration under the President of the Russian Federation, and the Sverdlovsk Oblast Government.

Nadezhda Rukavitsyna
Head of the Center for Support of Innovation Implementation, Center for Expertise and Quality Control of Medical Care of the Ministry of Health of the Russian Federation

Vaseliy Ryazhenov
Head of the Department of Regulatory Relations in the Field of Circulation of Medicines and Medical Devices, First Moscow State Medical University named after I.M. Sechenov of the Ministry of Health of the Russian Federation

Svetlana Solovyova
Assistant to the Minister of Health of the Russian Federation