Speakers 2021

Elena Denisova has the experience and knowledge in the areas of registration and reregistration of foreign and domestic medicines, and inspecting of medicines manufacturers on compliance with GMP requirements. She has a certificate of GMP Inspector, issued by WHO. From January 2014 Elena Vladimirovna had been in charge of Division for medicines manufacturing licensing of the Department for pharmaceutical and medical industry development. In May 2017 she was appointed the Deputy Director of the Department for pharmaceutical and medical industry development of Minpromtorg of Russia. Almost 9 years Elena Denisova was working in Roszdravnadzor, where, as well, she was in charge of medicines registration area. Her general experience in pharmaceutical field is 20 years, including employment in major companies, manufacturing medicines – 5 years.

Mr. Nguyen Ly is Executive Director, Biologics Technical Product Leader in the Manufacturing Division at MSD, where he is responsible for advancing the technical organization to support successful life cycle management of biologics product portfolio. Over the past 22 years at MSD, Mr. Ly has held a broad range of technical roles across the manufacturing network and has supported numerous technology transfers for vaccine and biologics products. Mr. Ly began his career as an engineer within the bulk API manufacturing organization and moved on to technical roles with increasing responsibilities in Vaccine Technology and Engineering, the Biologics Pilot Plant, and External Manufacturing Drug Substance and Drug Product. While at MSD, Mr. Ly took on an international assignment supporting transition of an internal clinical site to commercial in support of accelerating Keytruda commercialization as well as establishing the External Manufacturing Technical organization in Switzerland. More recently, Mr. Ly took on the role of Keytruda Technical Product Leader while also working to establish the Biologics Technical Product Leadership organization. Mr. Ly holds a Bachelors of Science Degree from Drexel University in Chemical Engineering and is a graduate of the Emerging Leaders Program from Harvard University. Over the course of his career at MSD, Mr. Ly has acquired deep technical knowledge and combined with his strong leadership and collaboration skills, has established himself as a critical asset for the vaccines and biologics products.

Vladislav Shestakov (DOB: November 27, 1969, place of birth: Salekhard, Yamalo-Nenets Autonomous District, USSR) – Director of the FSI ‘State Institute of Drugs and God Practices’. Before the current appointment, Director Shestakov chaired the Pharmaceutical and Biotechnology Department of All-Russia Public Organization ‘Business Russia’. Honorary Chemist, certified GMP inspector and auditor, Director Shestakov is also Deputy Head of the State GMP Inspectorate and Head of Good Practices Committee for professional qualification of the National Pharmaceutical Chamber. Director Shestakov has been actively engaged in the public healthcare and pharmaceutical industry since 1997. Mr. Shestakov was born in Salekhard on November 27, 1969. In 1987 he entered the Tyumen State Medical Institute, and continued education in 1989 in the Smolensk State Medical Academy. In 2005 he graduated from the State University of Management majoring in “State and municipal management”. Graduated from the Academy of Labor and Social Relations in 2008, majoring in “Business management”. In 2016 he received a diploma of advanced professional training at the Moscow Institute of Physics and Technology (MIPT) majoring in "Current good manufacturing practices of pharmaceutical production and quality control - theory and practice of GMP inspections / audit." In early 2000 Mr. Shestakov was Deputy Director General of the Irbitsky Chemical Plant. In 2001 – as Vice President of the Russian Medical Production Association ‘RosMedProm’ – he initiated activities aimed at the low price pharmaceutical production and offered manufacturers a whole number of cost effective recommendations for their product portfolios. In 2002 he headed Sales Department of German company ChemoPharm’s office in Moscow. Worked as Deputy Director General in Makiz-Pharma Ltd. in 2004, and became Director General of the Skopin Pharmaceutical Plant in 2005. In 2007 held the position of Director for Government and Public Relations in NGO ‘Alliance of professional pharmaceutical organizations’. In 2008 he was offered the post of President at EpidBioMed corporation. In 2009 Mr. Shestakov managed Business Development Department in ‘BinnoPharm’ company. After he left the Usolye-Sibirskoye Chemical and Pharmaceutical Plant where he was Director General’s Adviser in 2011-2012, Mr. Shestakov took the position of NanoLek company’s first deputy Director General from 2012 through 2013. As of November 27, 2013 Mr. Shestakov was appointed as Director of the FSI ‘State Institute of Blood Substitutes and Medical Preparations’ (later renamed as State Institute of Drugs and Good Practices). As of 2003, he is a regular lecturer of professional development programs on managing commercial and government organizations, as well as specialized programs in pharmacy and pharmaceutical production. He is a certified a certified international GMP inspector of the World Health Organization.

• Honorary Chemist of the Russian Federation
• Letter of Appreciation ‘For Professional Excellence’ signed by the Russian Minister of Industry and Trade
• Letter of Appreciation signed by the Deputy Health Minister of the Syrian Arab Republic "For Meritorious Contribution to Cooperation between Russia and Syria"

• In 1998 he graduated from the «Vitebsk state medical Institute».< / li>
• 1999-2002 – post-Graduate studies, then clinical studies in Vitebsk state medical University on a speciality «Clinical pharmacology».
• 2002-2004-Department of General and clinical pharmacology of Vitebsk state medical University (Republic of Belarus).
• 2004-2014-Republican clinical and pharmacological laboratory of up «Center of examinations and tests in health care» (Republic of Belarus).
• 2014-present Eurasian economic Commission, Department of technical regulation and accreditation (Russian Federation).

Clinical studies of drugs, biological statistics, clinical pharmacology. The planning, implementation and quality assurance of more than 140 studies reproduced (generic) drugs in the Republic of Belarus, 30 clinical trials of medicines (Allergy, cardiology, neurology, ophthalmology) I and III phases.