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

13-14 November 2018

InterContinental Moscow Tverskaya Hotel

Speaker confirmations in 2018:

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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.  

Steven Bukvic graduated from Coventry University in 1982 with a degree in Applied Biology. After serving in the commercial sector of the UK motor industry for 8 years, Steven joined the Pharmaceutical Industry in 1990. For the next 27 years Steven’s career in the Pharmaceutical / CRO sectors has covered a broad range of disciplines within the field of clinical research, including clinical site monitoring, project management, pharmacovigilance, training, quality assurance and business operations. Steven has worked in Covance, GSK, MSD and Pfizer to name just a few of the key companies in his career and has had extensive geographical exposure having worked in the UK, US, Germany, China and the Russian Federation. Steven joined Synergy in 2017.

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Medical doctor (cardiology, intensive care) by training, with scientific and clinical expertise, MBA education, working in international pharma industry research since 2004. Currently in a position of Clinical Research Director, with overall responsibility for international phase 2-3 clinical trials delivery in Russia.

Experience

Clinical Research Director at AstraZeneca (2014 – Present)

Clinical Research Manager at AstraZeneca (2013 – 2014)

Clinical Research Manager at Abbott Laboratories (2010 – 2013)

Overall responsibility for organization of local clinical trials (phase 2-4, PMOS and investigator-initiated studies)

Clinical Project Manager at Abbott Laboratories (2007 – 2010)

Clinical Project Leader, Clinical Research Associate at AstraZeneca (2004 – 2007)

Cardiologist, Intensivist. Clinical co-investigator at Peoples’ Friendship University of Russia and Moscow Municipal Clinical Hospital 64 (2001 – 2004)

Co-investigator in phase 2-3 studies, post-graduate student, research fellow. Publications in clinical pharmacology, clinical trials, evidence based medicine.

Education

Moscow International Higher Business School MIRBIS (Institute): MBA, Strategic Management 2009 – 2011

Peoples’ Friendship University of Russia: MD, Medicine, Cardiology1994 – 2004

2004 — Intensive Care Unit Specialist, specialty certificate

2003 — Cardiologist, specialty certificate

2001 — MD, Russian Peoples' Friendship University, Diploma with honors. French-Russian Translator, Diploma with honors

Publications: over 20 (original publications on clinical and epidemiology studies, reviews in evidence-based medicine, cardiology).

 

Establishing clinical development strategy from the pre-IND setting to pivotal trials and registration with focus on biosimilars of insulin and insulin analogues.

Joined GEROPHARM as a head of clinical trials department in Oct 2016. During this time along with the clinical trials department team successfully performed several clinical trials including hyperinsulinemic euglycemic clamps and bioequivalence. Incorporates elements of Risk Based Monitoring into clinical trials department at GEROPHARM.

Provides training for GCP, monitoring, soft skills (public speaking, presentation skills), mentoring junior members of clinical trials team. Established Clinical Research Community in Saint-Petersburg with monthly meetings for different aspects of clinical trials discussion.

Has joined clinical trials since Jan 2011. Worked in Quintiles in Endocrinology, Rheumatology, Cardiovascular, Oncology trials.

As a Clinical Lead in Quintiles participated in studies driving clinical part. Member of the core project team working with the Project Leader to ensure overall project delivery. Collaborated with other key team members to establish an integrated set of plans and be ultimately accountable for results of the clinical team. Responsible for right subjects and right data to meet all contractual requirements since sites selection to database lock activities. Ensures clinical part of TMF filing.

MD (Saint-Petersburg State Medical Academy in 2006 with honor). PhD in the field of medicine, Saint-Petersburg State Medical Academy 2006-2009). Experience as research fellow in preclinical studies (in gastroenterology, respiratory diseases, rheumatology, diabetes mellitus, metabolic syndrome, acute pancreatitis, multiple sclerosis).

2007-2013 – teaching students in cytology, cell biology, genetics at the course of medical biology.

Has 17th publications including international, participation in international conferences as a speaker (Groningen, Netherlands, Bodrum, Turkey; Davos, Switzerland etc).

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Yuri Zaretsky, M.D. is the President and CEO of ZM CRO GROUP, a group of Canadian, Russian, and Chinese CROs established in 2004, specializing in medical affairs and drug safety. Dr. Yuri Zaretsky graduated from 2nd Moscow State Medical University, Russia in 1987. He completed residency in abdominal surgery, also residency in anesthesiology, resuscitation and intensive care. Following his post-graduate work, he served at the Vilnius University Hospital, Vilnius, Lithuania as a senior anesthesiologist/resuscitation specialist and director of pain management clinic.
Dr. Zaretsky’s professional career in clinical trials began as a primary investigator where his interest in the design, conduct of clinical trials and analysis of data evolved. Dr. Zaretsky has more 20 years clinical trials experience in a variety of therapeutic areas. In 2004, he established ZM CRO GROUP, a medical affairs and drug safety group of CROs, which over the years, has evolved into a respected force in the CRO field. Dr. Zaretsky’s continuing research interests lie in drug safety, medical monitoring, medical review, and data management.

Dr. Vladimir  Popov  has 21  years of Phase I-IV clinical trials   experience and  participated  in  trials as co-investigator, PI,  CRA, Project Manager in fields of Cardiology, Pulmonology, Oncology, Hematology, Dermatology, Neurology.

Postgraduate training on Internal Medicine/Cardiology:

Internship at the Republican Cardiological Hospital, Kharkiv, Ukraine.                                                                                                                                                                                  Residency and Fellowship at the Institute of Therapy. Academy of Medical Science of Ukraine. Kharkov, Ukraine (300 beds multiprofile therapeutically hospital) at the following departments: Cardiology, Gastroenterology, Pulmanology, CCU, Nephrology, Endocrinology, Rheumatology, Clinical Pharmacology. 

Awarded Master’s Degree in Internal Medicine. PhD  in Cardiology.

September 18, 2007  awarded Doctor of Medical Sceince,  dissertation in Cardiology.  Author of 164 papers (including 55 articles in refereed journals), 7 manuals and 4 monographs (co-author of chapters).

Participated in 1 FDA and 2 Roszdravnadzor’s inspections.

He is self-confident, untrusting, effectively meets  challenges of various projects.

Dr. Popov experience regarding dealing with complex issues of submissions to regulatory authorities, safety ,   patient recruitment has always allowed to pass projects on time in accordance to plan.

Editorial Board member:

Pharmaceuticals registration and development.  www.pharmjournal.ru, Moscow, Russia.

Medicine in the Railway Field and Occupational biorhythmology, Moscow, Russia

International Society Membership:

Member of European Society of Arterial Hypertension; Member of European Society of  Cardiology  of Cardiovascular Pharmacotherapy workgroup; Member and National Coordinator of International Society of Cardiovascular Pharmacotherapy ISCP www.iscpcardio.org

Member of Multiregional Organization “Pharmacoeconomical Researces Society’’ www.rspor.ru; Member of International Union of Railway Medical Services (UIMC); Member of International Union Of Pharmacy; Medical Expert of International Romualdo Del Bianco Foundation, Florence, Italy www.fondazione-delbianco.org

Member of the Academic Council of NGHCI "Scientific Medical Center" JSC "Russian Railways", Moscow

Chairman of the Ethics Committee of NGHCI "Scientific Medical Center" JSC "Russian Railways", Moscow

Principal Investigator of Clinical Trials, added to investigator register (code 2481) http://grls.rosminzdrav.ru

Scientific Achievements: social award “Da Signa”, 2013, in healthcare, Pharmacoeconomy, Rational Pharmacotherapy (http://www.nfrz.ru/dasigna) in the nomination "The use of the results of pharmacoeconomic studies in clinical practice" for the work "Pharmacoeconomic study of  medical care volumes in professional examination of patients with cardiovascular disease" (V.F. Pfaf, A.Z. Tsfasman, V.V.Popov).

Maria completed her Ph.D. course in the Rheumatology Department of the Moscow Medical Academy named after I.M.Setchenov in 2002. She holds an MD degree from the same institution.
Maria possesses over 5 years of experience (2001-2006) with Novartis Pharma Russia in the positions of Local Drug Safety Officer and then Medical Adviser.
Maria works in ALMEDIS since May 2006. In 2006-2012 she was responsible for ALMEDIS Quality Management System development and maintenance. As QA Manager, she was ensuring compliance with international standards at all stages of project execution (from scientific concept development to data analysis and clinical study report preparation).
As ALMEDIS Executive Manager, since 2012 Maria Nassonova manages high-level, strategic aspects of CRO business.
Maria represents ALMEDIS and participates in the work of the Association of Clinical Trials Organizations (ACTO) – non-commercial organization of the companies/ legal entities and clinical research community engaged in clinical trials in Russia, since 2015 Member of the Board, since 2017 Сo-Сhair of the Board.

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.

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