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 2017:

Kirill Tverskoy joined pharmaceutical business in 1995 as the Clinical Research Associate at Omnicare Clinical Research CRO brunch in Moscow. In 2002 he joined Pfizer Russia as Clinical Trial Coordinator. In 2006 Kirill became a leader of Country Clinical Operations being appointed to the position of Manager Clinical Research Russia and later on in 2007 – to the position of Medical Director, Pfizer Russia.

Kirill was graduated from the Department of Physical and Chemical Biology, Moscow Institute of Physics and Technology with the degree of MSc in Biophysics (2001). After graduation he worked as the Research Associate at the Institute of Immunology, Russian Ministry of Health in Moscow. In 1997 after completing his post-graduate theses in Immunology and Allergology he has gained PhD in biology.

 

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).

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).

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).

 

Obernikhina Elena, Pharmacovigilance manager in the Pharmacovigilance HUB for Eurasian Economic Union countries and Mongolia in ZAO GlaxoSmithKline Trading. Graduated from the 1st Moscow Medical Institute named after I.M/ Sechenov, Medical Doctor (internal medicine, cardiology and functional diagnostic). Has been working for GlaxoSmithKline since 2004 and has been involved in clinical safety and pharmacovigilance.

Ermishina Olga, EAEU Qualified Person for Pharmacovigilance in Bayer company. She graduated from Russian State Medical University, biophysics course. Olga is in pharmaceutical business since 1997, being involved in product promotion, medical support and clinical trials in international pharmaceutical trials. Last 12 years she is in pharmacovigilance.  

 

Dmitri Pavlovich graduated from Russian State Medical University in Moscow with the diploma of “general physician”. His postgraduate course was in intensive cardiology. In this area Dmitri spent more than 10 years working as an attending physician in intensive cardiac care unit of Main Military clinical hospital in Moscow. It was useful and unique practical experience to become familiar with different spheres of emergency medicine not limited only to cardiology. Already at that stage Dmitri became interested in clinical trials and worked as co-investigator in few of them. As a result the decision to leave practical medicine and to switch in to clinical research industry did not appear to be something sudden and unexpected. Dmitri tried himself working in different roles and positions: clinical research associate, clinical team lead, line manager for clinical staff. He closely interacted with all key players in clinical research: investigators and hospital administrations, regulatory officials and members of ethics committees, representatives of pharma companies and top managers of the company Dmitri worked in. At the same time it was not just pure practice, during more than 15 years in clinical research Dmitri constantly educated himself, making and emphasis on innovative approach and industry leading technologies. For the last three years Dmitri works as Head of QuintilesIMS representative office in Russia and leads clinical research team on a country level. QuintilesIMS continues to lead international clinical research market in Russia, being number one in the number of study protocols and sponsor diversity.

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.

Anna started her career in clinical trials in 2007 at the Matrix Pharmaceuticals Research company. She joined Pfizer as Clinical Research Site Manager in 2008, and was appointed to the role of Clinical Operations Lead in 2010. For the period since November 2012 till December 2013 she worked for F.Hoffman-La Roche company as Country Study Manager. For the period since January 2014 till November 2016 she was responsible for local clinical trials conduct as Research Project Manager at Pfizer.

Anna was graduated from Samara University with degree ‘Specialist in Biology’ in 1997, then she had study course in Genetics and Microbiology at Vienna University (1997-1998).  She worked for more than 10 years as scientific employee at different scientific organizations, including The Institute of Ecology of the Volga River Basin of the Russian Academy of Sciences (IEVB RAS). Anna has an additional graduation in Project Management (Plekhanov Russian University of Economics, 2014)