Andrey Vasilyev

Graduated from I.M. Sechenov Moscow Medical Academy (Sechenov University) with a Doctorate of Pharmacy in 1993. From 1993 to 2016, he worked as an assessor/reviewer and a director of the Center for Drug Evaluation and Control at FSBI ‘Scientific Center for Evaluation of Medicinal Products’ of Ministry of Health assessing non-clinical and clinical parts of marketing authorization applications and clinical trial applications. Since 2000, he holds a Ph.D. in Clinical Pharmacology. Since 2013 he is a Doctorate of Science in Clinical Pharmacology. Beginning in 2016, he is a drug development and authorization specialist at Center of Scientific Advice Ltd. He has over 80 publications in scientific journals. His areas of interest include regulatory affairs in human medicines, biosimilars, generic medicinal products, pharmaceutical legislation of the U.S., EU, and EAEU.

Margarita Dranitsyna

Graduated from A.I. Evdokimov Moscow State University of Medicine and Dentistry with a Doctorate of Medicine in 2006. In 2009, she completed a 3-year residency in Dermatology and Venerology. From 2006 to 2009, she studied statistics at Lomonosov Moscow State University, Faculty of Computational Mathematic & Cybernetics. She worked in the medical publishing house ‘GEOTAR’ between 2006 and 2009 where she was managing translation of the United States Pharmacopeia and National Formulary (USP 29–NF 24). She worked in the Elsevier between 2009 and 2011; then from 2012 to 2014 in the MedWEB medical educational platform. From 2014 to 2016, she worked as an assessor/reviewer at FSBI ‘Scientific Center for Evaluation of Medicinal Products’ of Ministry of Health conducting a biostatistical review of marketing authorization applications and clinical trial applications. Beginning in 2016, she is a biostatistician and clinical development/regulatory affairs specialist at Center of Scientific Advice Ltd. She has over 15 publications in scientific journals. Her areas of interest include mathematical statistics, planning and processing of non-clinical and clinical data, innovator and generic products, biologics and biosimilars in accordance with the U.S., EU, and EAEU requirements.

Elena Gavrisihina

Graduated from I.M. Sechenov Moscow Medical Academy (Sechenov University) with a Doctorate of Medicine in 1995. In 1995 to 1996, she completed a 1-year internship in Internal Medicine, and she was certified as a clinical pharmacologist in 2003. From 2000 to 2016, she worked as an assessor/reviewer at FSBI ‘Scientific Center for Evaluation of Medicinal Products’ of Ministry of Health assessing non-clinical and clinical parts of marketing authorization applications and clinical trial applications. During 1996 to 2014, she was teaching clinical pharmacology at I.M. Sechenov Moscow Medical Academy, Department of Clinical Pharmacology. Since 2013, she holds a Ph.D. in Clinical Pharmacology. Beginning in 2016, she is a regulatory affairs and non-clinical and clinical development specialist at Center of Scientific Advice Ltd. He has over 40 publications in scientific journals. His areas of interest include regulatory affairs, clinical development, medical writing, authorization of pharmaceuticals in accordance with national and EAEU requirements.

Ravil Niyazov

Graduated from Kazan State Medical University with a Doctorate of Medicine in 2007. In 2008, he completed a 1-year internship in Internal Medicine, and he was certified as a clinical pharmacologist in 2009. In 2012, he graduated from Russian Presidential Academy of National Economy and Public Administration with a bachelor’s degree in Public and Municipal Administration. He worked in the medical publishing house ‘GEOTAR’ between 2008 and 2009. From 2009 to 2016, he worked as an assessor/reviewer at FSBI ‘Scientific Center for Evaluation of Medicinal Products’ of Ministry of Health assessing non-clinical and clinical parts of marketing authorization applications and clinical trial applications. Since 2012, he holds a Ph.D. in Clinical Pharmacology. Beginning in 2016, he is a regulatory affairs and non-clinical and clinical development specialist at Center of Scientific Advice Ltd. He has over 40 publications in scientific journals. His areas of interest include regulatory affairs, bioavailability and bioequivalence, biosimilars, pharmaceutical development, early development, pharmaceutical legislation of the U.S., EU, and EAEU.

Evgenia Tsareva

Graduated from I.M. Sechenov Moscow Medical Academy (Sechenov University) with a Doctorate of Medicine in 2004. In 2004 to 2005, she completed a 1-year internship in Internal Medicine. In 2007, she completed a 3-year residency in Clinical Pharmacology. From 2007 to 2016, she worked as an assessor/reviewer at FSBI ‘Scientific Center for Evaluation of Medicinal Products’ of Ministry of Health assessing non-clinical and clinical parts of marketing authorization applications and clinical trial applications. Since 2012, he holds a Ph.D. in Clinical Pharmacology. Beginning in 2016, she is a medical writer at Center of Scientific Advice Ltd. She has over five publications in scientific journals. Her areas of interest include clinical development, authorization of pharmaceuticals based on the U.S., EU, EAEU, and national requirements.

Dmitry Kulichev

Graduated from Tver State Medical Academy with a Doctorate of Medicine in 2009. In 1995 to 1996, he completed a 1-year internship in Endocrinology at I.M. Sechenov Moscow Medical Academy (Sechenov University). In 2010 to 2013, he worked as an endocrinologist, concurrently taking part in clinical trials as a co-investigator. In 2013 to 2015, he worked in QuintilesIMS as a scientific officer where he was responsible for CRA activities in multicenter phase 3 clinical trials, phase 1 trials, and bioequivalence studies as well as for medical writing of clinical trial application particulars such as protocols, IBs, ICFs, CRFs, CSRs). In 2013, he completed an educational training course CRA University (including ICH GCP) at Quintiles. From 2015 to 2017, he worked as an assessor/reviewer at FSBI ‘Scientific Center for Evaluation of Medicinal Products’ of Ministry of Health assessing non-clinical and clinical parts of marketing authorization applications and clinical trial applications.

His areas of interest include regulatory affairs, clinical development, authorization of pharmaceuticals based on the U.S., EU, EAEU, and national requirements, management of clinical trials.