The only international event dedicated to discussing regulatory, ethical and operational aspects of running clinical trials in Russia

30 November - 1 December 2021

Moscow, Russia, Intercontinental Hotel

Speakers 2020:

In 1995 Sergey Dubrovin received MD from the Moscow Medical Density University (Medical Faculty).  Finished his post-graduation in the same university (Chair of Therapy) and worked as a general practitioner and a gastroenterologist in Moscow City Clinical Hospital #67. In 2002 I’ve received PhD in internal diseases. He’s joined the industry in 2001 (Janssen Pharmaceutica) as a CRA and starting from 2005 have held position of Local Trail Manager being in charge of oncology and hematology studies. In 2014 Sergey joined Pfizer as a Reginal Medical Monitor for Russia, Ukraine, Georgia, Belarus, Bulgaria and Israel specializing in oncology and hematology studies. In 2016 Sergey was appointed to the position of Director of Clinical Site Management, Russia and Belarus.

Dr. Mikhail Samsonov is currently Head of Development, Medical and Regulatory at  R-Pharm managing all activities across several therapeutic areas (cardiology, oncology, infectious and autoimmune disease)  in fast growing R&D company. He is a member of several Joint Steering Committees with Merck, Eli Lilly, UCB, Theravance, Quintiles etc dedicated to technology transfer, development and commercialisation of innovative medicines, biosimilars and generics .

Prior R-Pharm he was Chief Scientific Officer at Novartis Russia & CIS overseeing all R&D activities for Novartis in one of key complex emerging markets and  member of Board of Directors Association of Clinical Trials Organizations in Russia in 2009-2011.

Dr Samsonov was Executive Director Regional Clinical Operations at Bristol-Myers Squibb Company overseeing EMEA and Asia Pacific regions including such emerging markets as China, India and Eastern Europe during last three years in BMS.  With over 14 years of experience at BMS in variety of roles in medical affairs and clinical operations, Dr Samsonov has dedicated much of his career to building capabilities in fast-growing clinical research markets , continuous productivity improvement in well established R&D markets and developing  10 new molecules in several areas ( antibiotics, autoimmune, CNS, CVS, oncology, virology). He was based at several BMS offices in the US, UK, Russia and Belgium.

Dr. Samsonov’s education includes MD from Moscow Medical University, National Cardiology Centre (Moscow) training  in Clinical Cardiology,  Ph.D. in Cardiology & Immunology from National Cardiology Centre, BA from Open University, London and several  business courses at INSEAD and OWEN business school.

He is an active speaker and panel expert at Columbia Business School, NY and various international conferences DIA, BIO USA, industry and investor meetings  on development  strategies, operational models, vendor management  in established and  emerging markets.  

Dr. Aleksandr Solodovnikov has 14 years of clinical trial expertise as an  investigator, CRA, clinical operations trial lead and clinical operations manager in fields of Endocrinology, Psychiatry, Cardiology, Pulmonology, Oncology, Hematology, Dermatology, Neurology, Surgery and Infectious Diseases (more than 30 trials, phase I-IV).

Aleksandr graduated from the Ural State Medical Academy (now University) in 2003 and started his scientific career at the Chair of preventative and family medicine resulting in a PhD in Rheumatology in 2009. Dr. Solodovnikov is now an associate professor of this Chair supervising edivence-based medicine and biostatistics fields.  Aleksandr received his training in statistics and epidemiology at the University of Manchester, UK, and at the Erasmus University, the Netherlands, and personally prepared and conducted more than 300 various statistical analyses in various statistical software packages (NCSS, Stata, R, SPSS, Statistica and other) and provided a lot of consultations in this field. He further developed his professional skills in clinical research by taking the “Principles and Practice of Clinical Research” course at Harvard Medical School in 2014. In 2016, Aleksandr also successfully completed the “Project Management Professional”.

Dr. Solodovnikov is a skillful trainer and lecturer, and has conducted numerous GCP trainings as well as seminars in biostatistics, evidence-based medicine, clinical research, drug development and regulations in clinical trials. He knows local, regional (EAEU) and international clinical trial regulations and guidelines well, and took part in the development of hundreds of clinical trial documents for medicines, medical devices, cosmetic and dietary products, and biologically active substances, starting from study concept and ending with the final protocol.

Dr Crawley is the Executive Director of the Good Clinical Practice Alliance – Europe (GCPA) in Brussels, Belgium and a World Health Organization (WHO) Expert in ethics. Responsible for the coordination of the Strategic Initiative for the Developing Capacity in Ethical Review (SIDCER). He is a philosopher specialising in legal, regulatory and ethical issues concerning medical research, teaching at several European Universities. He is the past Secretary General, Ethics Officer and Chairman of the Ethics Working Party at the European Forum for Good Clinical Practice (EFGCP) where he also was the editor of the EFGCP news. He is currently Chairman of the Ethical Review Committee of the International Network for the Cancer Treatment and Research Association (INCTRA). He has been a member of the EMVI-AMVTN Ethical Review Committee, a permanent liaison to the International Bioethics Committee of UNESCO.

 

 

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