Eleven years of professional experience in the industry.

Saint-Petersburg State Chemical-Pharmaceutical Academy;
Advanced training in GMP/GDP-inspections; GMP-inspector.
Certified GMP/GDP facilitator of WHO Global Learning Opportunities.
ISPE member since 2017

Embarked on his career at the production site of active pharmaceutical ingredients. From 2008 to 2013 Vladimir worked at the State Research Institute of High Pure Biopharmaceuticals (Federal Bio-Medical AgencySt. Petersburg) as a Validation Engineer. In 2013-2014 he participated in the launch phase of “Novo Nordisk” – an insulin production site in the city of Kaluga. There he was in charge of manufacturing of aseptic and sterile production. In 2014 Vladimir joined the newly created Inspections Department at the State Institute of Drugs and Good Practices, where he progressed from the position of a leading expert/auditor all the way to Deputy Head of the Department. In 2017, he was appointed as Deputy Head of the institute’s training center.

Date of birth: 18th of May, 1953, in the village of Taishevo in the Kukmorsky district, TASSR.

Graduated from the Kazan State Medical Institute named after S.V. Kurashov (1976)

From 1976 to 1989 – resident, head of the research sector, senior lecturer, associate professor of the Kazan Medical Institute named after S.V. Kurashov.
From 1989 to 1994 – Minister of Health in the Republic of Tatarstan.
From 1994 to 1997 – worked as the head of the Inspectorate of the State Control of Medicines and Medical Devices of the Ministry of Health of the Russian Federation, Moscow.
From 1998 to 2001 – supervised the Department of quality control, efficiency, provision of funds and medical equipment of the Ministry of Health of the Russian Federation.
From 2001 to 2007 – Director General of RAO “Biopreparat in Moscow”.
From 2004 – moved to the position of the head of Roszdravnadzor and occupied it until 2007.
From 2007 to 2009 – Deputy Director of the Department of Social Development, Government of the Russian Federation.
From 2009 to 2013 – First Vice-Rector of the Russian National Research Medical University named after N.I. Pirogov.
From 2011 to 2015 – Director General of the Russian Anti-Doping Agency “RUSADA”.
From 2013 – Director of the Federal State Budgetary Scientific Institution “National Research Institute of Public Health named after N.A. Semashko »

Soviet and Russian physician, Doctor of Pharmaceutical Sciences (2003), Doctor of Medical Sciences (1995), Professor, Academician of the Russian Academy of Medical Sciences (from 2011) and Russian Academy of Science (from 2013), Honored Doctor of the Republic of Tatarstan, Honored Doctor of the Russian Federation.

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”

Petr Rodionov was born in 1978 in Leningrad. He graduated from the school of economics at the Saint-Petersburg State University and interned in the Yale school, USA (1995–1996).

Petr Rodionov is a head of GEROPHARM since 2001. Under the leadership of Petr Rodionov GEROPHARM has become large and efficient business structure allowing the company to become one of the noticeable players of Russian pharmaceutical market and an expert of professional association.

In 2013–2017 Petr Rodionov won the award “Chief of the Year”, achieved “TOP-250 of General Directors of Russia”, was twice recognized as an “Expert of the Year” (“Expert of the Northwest”), won the competition “Businessman of the Year” (EY) and RBC award (Saint-Petersburg).

He is a head of the section “Medicine and Pharmaceutics” of the Government Council for patronage in social sphere and a participant of the Subcommittee on drug circulation of the Government Commission for public health. In 2016 Petr Rodionov became a member of the Expert Advisory Body under the State Duma Committee on biotechnologies development, pharmaceutical and medical industry and also a member of the Social and Business Council on the main strategic direction of the Russian Federation “Health Care”. Petr Rodionov is a member of the All-Russia Business Association “Delovaya Rossiya” (“Business Russia”).

Born in 1983 in St. Petersburg.

Graduated in 2007, Russian Military-Medical Academy in the specialty “General practice”, in 2008 – internship at the Russian Military-Medical Academy in the specialty “Therapeutics”.

2008-2009 – Head of the medical center – doctor of the Central artillery ammunition base of the Baltic Fleet.
2009-2010 – Medical specialist, Saint-Petersburg I.I. Dzhanelidze research institute of emergency medicine.
2010-2012. – Chief Expert, Consultant, Counsellor at the Ministry of Health and Social Affairs of the Russian Federation.
From 2012 to Present – Deputy General Director, Project leader, GR of BIOCAD.

Takes an active part in shaping public health policy, drug supply and the development of the Russian pharmaceutical industry.

Married and has a son.

He graduated from Kazan state medical University, has additional higher financial and economic education, MBA in innovation and project management. Member of the presidential program of management training.

Author of 16 scientific works, 1 monograph.

In 1992 he graduated from the medical faculty of RMI. Akad. I. P. Pavlova (Ryazan). He has a degree of doctor of medicine (03.01.04 Biochemistry); associate Professor (Department of pharmacology with the course of pharmacotherapy).

1984-2001-doctor, senior laboratory assistant, trainee teacher, post-graduate student, assistant Professor of pharmacology with a course of pharmacotherapy of the faculty of postgraduate education, curator of the cycle of professional retraining «Clinical pharmacology», Ryazan medical University. Akad. I. p. Pavlova (Ryazan). Polyclinic of Ryazan regional clinical cardiology dispensary, I-e cardiology Department of ROKD (Ryazan).

1993-2011-medical representative, promotion Manager, hospital sales Director, regional Director, medical Director in international and domestic pharmaceutical companies.

2002-2004-associate Professor of the Department of biochemistry of the medical faculty of RUDN (Moscow).

2002-2011-senior researcher of the research group of the research center; associate Professor of pharmacology; chief specialist of the Department of organization of preclinical and clinical studies of drugs; Professor of the Department of pharmacology, head of the educational part of the Department of pharmacology, authorized for the quality of educational and scientific work of the pharmaceutical faculty Of the FIRSTI. M. Sechenov (Moscow).

Since 2011-present – Deputy Director, Director centre of expertise of drug safety, Deputy Director General, ntsesmp Ministry of health of Russia on scientific work.

Author of University and postgraduate Federal educational programs: «GXP-system of good practices: GEP, GMP, GLP, GCP, GDP, GPP, GVP» (2006), «Product management» (2006), «Promotion Management» (2006), «Ensuring and quality control of production of medicines-GMP» (2006), «Clinical research of medicines» (2007).

• 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.

Moscow Lomonosov State University, Candidate of Chemical Sciences, MBA in Production Management, advanced training course in GMP/GDP inspection/audit.

In 1997 Ms. Chadova made a change in her career from laboratory research to pharmaceutical production. During the following 9 years she worked at MosKhimPharmPreparaty Company (Moscow Chemical and Pharmaceutical Production) progressing from the position of Production Technologist to Deputy Production Director.
From March 2006 through July 2010 worked at BinnoPharm company of the Medical Production Holding, bringing the business from the concept stage all the way to release of pharmaceutical products (including vaccines).
October 2010 – October 2015: “PharmMedica” Engineering Company.
As of October 2015 holds the position of Head of the Department for Inspection of Pharmaceutical Production. In 2018 appointed Head of the Administration for Inspection of Pharmaceutical Production and Expertise of the State Institute of Drugs and Good Practices.

Deputy director for science of Institute of translational medicine and biotechnology of Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)
Head of Chair of Industrial Pharmacy
Expert of the RAS, Member of the Council for professional qualifications in pharmacy, Member of the Public Council under the Federal Service for supervision in healthcare

1988 – M.V. Lomonosov Moscow Institute of Fine Chemical Technology. Speciality – technology of the basic organic and petrochemical synthesis
2001 – Sechenov Moscow medical academy. Speciality – pharmacy.
2011 – Doctor of Pharmacy
2014 – Higher school teacher (retraining)
2015 – Professor

1999-2001 – Deputy Director for Scientific and Production Issues, Bivitech LLC.
2001-2005 – Deputy Director for Scientific and Technological Work of State Unitary Enterprise “GNII Vitamin”.
2005-2007 – Head of the Laboratory of drug products technology in Research Institute of Pharmacy of I.M. Sechenov First Moscow State Medical University.
2005–2012 – Associate professor of the Department of organization of production and distribution of medicines I.M. Sechenov First Moscow State Medical University.
2012 – 2017 – Professor of the Department of industrial pharmacy I.M. Sechenov First Moscow State Medical University.
2007 – till present – Deputy director for science of Institute of translational medicine and biotechnology of I.M. Sechenov First Moscow State Medical University.
2017 – till present – Head of the Department of industrial pharmacy I.M. Sechenov First Moscow State Medical University

• Author of exemplary educational programs of further vocational education in industrial pharmacy, approved by the Order № 37n of the Ministry of Health of Russia on 22.01.2014.
• Author of the new field of education Industrial pharmacy (Order № 1508 of the Ministry of Education and Science of Russia from 01.12.2016).
• Author of the Federal State Education Standard in the field of education 33.04.01 Industrial pharmacy (master’s level), approved by the Order No. 705 of the Ministry of Education and Science of the Russian Federation on July 26, 2017.
• Author of 5 professional standards for specialists in industrial pharmacy.
• Author of new professions for specialists in industrial pharmacy.

Stephan Rönninger holds a PhD and engineering degree in organic chemistry from the Technical University of Darmstadt, Germany, is appointed as Adjunct Assistant Professor of Clinical Research and Leadership at the Georges Washington University, Washington D.C., US and as Academic Visiting Expert for the Centre of Regulatory Excellence (CoRE) at the Duke-New University of Singapore (NUS) Medical School, Singapore.

He is leading the Quality External Affairs organization in Amgen organizing the operational policy outreach and external ambassador program. He collaborates cross-functional internally and with external stakeholders including authorities, associations and competitors on topics regarding quality management, and good manufacturing and distribution practice (GMDP) as well as CMC topics by providing comments on regulatory guidelines, intelligence, and training.

He also represents Amgen in the European industry association EFPIA in the Technical Development Expert Group (TDEG) and acts as vice-chair. He represents EFPIA in the International Council for Harmonization (ICH) on the management sub-committees for training, and was a member of ICH Q9-EWG, ICH Q-IWG on Q8/Q9/Q10 and in the ICH Q7-IWG.

In the Parenteral Drug Association (PDA) he is elected for the board of directors, co-chairs several international conferences and training events (e.g. with PIC/S) and was chair of the Regulatory Affairs and Quality Advisory Board (RAQAB). He was the leader of the PDA-Europe Inspections Trends Interest group and one of the founders and chair of the ‘Paradigm Change in Manufacturing Operations’ (PCMO®) project in PDA.

Following his postdoctoral studies, from 1992-2013, Stephan worked for Roche in an API manufacturing site with responsibilities for laboratory and project management, and served as a production manager, within the Quality Assurance and Quality Management department. In 2003, he joined the Roche Global Quality organization with leadership responsibilities for the Roche Global Quality System and external collaborations. He joined Amgen in 2013.

He has received numerous awards, appreciation, and recognition by PDA, PIC/S, Health Canada, Peru, South Korean and Turkish agencies and US-FDA.

• In 1985, guraduated from the Graduate School of Pharmaceutical Science (master degree program at the Department of Pharmacoscience).
• In 2000, the Tokyo University (Ph. D. in Health Science).

• 1985 – 2004: Product Security Pharmacist and Quality Assurance Manager at a pharmaceutical company.
• 2004 – 2007: GMP inspector at the Office of GMP/QMS Inspection, PMDA.
• 2007 – 2010: Director for GMP Inspection, Office of GMP/QMS Inspection, PMDA.
• 2010 – 2017: Office Director, Office of Manufacturing/Quality and Compliance, PMDA.
• 2017 – present: Senior Director for Manufacturing/Quality and Compliance, PMDA.

Josef Kriegl is the Managing Director and Co-owner of Chemgineering International GmbH, a company within Chemgineering Group. Chemgineering is a worldwide partner for consulting services, and design & build projects in the life science industry. He is experienced in processes like: sterile, solid dosage forms, biotech, medical devices, food, cosmetics and consumer care and has successfully done projects in countries like: Austria, German, Switzerland, Russia, Iran, Saudi Arabia, Greece, Turkey, etc.

Prior to Chemgineering, he held various leading positions in international engineering companies, being in charge for Central Europe, South-East Europe, Eastern Europe as well as Middle East.

Josef is an Austrian and lives in Vienna.

Since 2003 he is a board member of the second largest ISPE Affiliate «Germany-Austria-Switzerland».

At the University of Applied Services in Vienna he is teaching for the Master Program «Bioprocess Technology».

Josef Kriegl holds a master degree in Mechanical Engineering and Business Economics from the University of Graz in Austria.

Continuous improvement of functions and sequences in the design and construction of life science production facilities, by taking future needs under consideration and gaining the most added value is his mission since many years.

Higher, faculty of physics and chemistry, Moscow Institute of steel and alloys. Candidate of physical and mathematical Sciences.

In 2000, he moved from a pharmaceutical sales company to the «Moscow enterprise for the production of bacterial preparations», WHICH was part of the FSUE «NPO «Microgen» where he worked as Deputy chief engineer – head of the Department of technical licensing and ecology.

From 2006 to 2010 he worked as Deputy General Director for technical development and capital construction of JSC Biomed im. Mechnikov (Petrovo-Far). Was responsible for the reconstruction of the branch of production associated DTP vaccine, areas of filling and packaging, as well as for the creation of a new biotechnology laboratory in the existing areas of the FSUE «Gosniigenetika» with a total area of 1500 square meters, including 800 square meters of net space. Until January 2015, he worked as a project Manager and then head of sales Department at Russian subsidiary of the Danish engineering company NNE Pharmaplan. From 2015 to 2017-contract production management Manager in Russia of Astellas.

From may 2017-head of the Department of good engineering practices of the FBU «Gilsinp».

Total experience in the pharmaceutical industry: more than 19 years.

In the field of pharmaceutical production, control and quality assurance, with specialization in solid dosage forms, liquid sterile and non-sterile forms, immunobiological and biotechnological preparations.

Graduated from Kazan State University. Got her MBA degree from Management School, Lancaster University (UK).

In 2011, became the winner in the nomination “Manager of the Year” of the prestigious Russian industry award “Platinovaya Untsiya”. Led by Valentina Buchneva, the project of the strategic partnership between Bosnalijek JSC and the largest national distributor CV Protek launched in 2007, boosted Bosnalijek key products to the leading positions on the Russian pharma market, having entered the top 10 in their categories already in 2010. This success served as the basis for inviting Valentina Buchneva to become the head of the Russian representative office of Bosnalijek JSC in 2015. During this time, due to her expertise, the structure of the representative office was optimized, and the geographical expansion of business to the CIS countries occurred within the framework of a unified business unit “Eurasia” creation.

Valentina Buchneva is one of the leading experts of the Russian pharmaceutical market, regularly participating as an invited speaker and moderator at major industry events.

Lilia Titova is a pharmacist with a diploma from the Sechenov Moscow Medical Academy.

She is currently the SPFO Executive Director elected to this position in October 2014.

In 2008 – 2014 Miss Titova was Director General of the Pharmaceutical Industry Journal published by the Association of the Russian Pharmaceutical Manufacturers.
In 2007-2008 she was Assistant to a Deputy Head of the Federal Service for Supervision in the Russian Healthcare System.
In 2005-2007 Lilia Titova served as Director General of the Association of the Russian Pharmaceutical Manufacturers.
In 2000-2005 she was a Deputy Pharmaceuticals Director for Zheldorfarmatsia of the Russian Ministry of Railroads.
In 1999-2000, Lilia Titova served as a Deputy Head of the Department for the Organization of Supplies in Pharmaceuticals and Medical Devices of the Russian Ministry of Health.
In 1994-1998 she was Marketing Director for a major local pharmaceutical manufacturer

In the Soviet Union she worked in the USSR Ministry of Health.

1979 – 1985 The diploma excellent degree of Moscow chemical technological institute; qualification: engineer chemist – technologist

19 years «Akrikhin»
10 years «Gedeon Richter-Rus»
3 years «Takeda Pharmaceuaticals»

2015-2012 Quality director, QP, « Takeda Pharmaceuaticals »
2012-2004 Quality director, QP, « Gedeon Richter-Rus »
2004-2002 QC Head, «Gedeon Richter-Rus»
2002-1998 QA Head, deputy Qaulity director АО « Akrikhin »
2015-2018 Quality director, QP, АО « Akrikhin »

GMP background and skills: Ministry of industry and trade Russian GMP working group member, a leading GMP auditor in the international teams of auditors in Takeda and Gedeon Richter, 3 years-the official representative of foreign sites in GMP certification for the Russian Federation GMP Guideline compliance.

In 2010 she graduated from PFUR, the Pharmacy faculty, on a specialty “Pharmacist”, Moscow.
In 2001 she graduated from the Moscow State Regional University, faculty of General Biology.

2011 “Technology of pharmaceutical products”, PFUR, Moscow

2016-“Chemical technology of radiopharmaceuticals” FMBA of Russia, Moscow
2012-“Cellular products. Principles of operation and organization of production in accordance with GMP” FGBU Dr.Burnazyan State Research Center, Moscow
2011-“Pharmaceutical Technology” PFUR, Moscow.

15 years of experience on pharmaceutical production sites, including:
– Deputy Quality Director, authorized person, OJSC “Valenta Pharm”
– Head of Quality Department, OJSC “ISKCH”
– Leading QA specialist, CJSC “Partner”.

Over the past 5 years, she works as a GMP expert at IBA. The responsibilities are related to the development of the pharmaceutical quality system on injectable and sterile radiopharmaceuticals production sites.
She has received trainings on radiopharmaceuticals production and quality control in Belgium, Austria, and the Netherlands.
Being a member of ECA European Academy, she studies in Europe every year. In Barcelona (Spain) she has received a EAC certificate of a GMP-auditor.
Her articles are published in the following journals: “GMP News”, “Quality Management in Healthcare and Social Development” edited by E.A. Telnova.
She organized a training for FBU “GILS and NP” about “Specifics of inspecting radiopharmaceuticals production sites”.
She received a thanks letter from Mr. M.V. Zabelin, Deputy Head of FMBA Russia