- Structural approach in bringing the Russian industry to an international level
- Actions of the regulatory authorities during the pandemic.
- Experience of inter-agency interaction.
- Analysis of decisions made and their results
- Experience of foreign drug regulatory authorities
- , Director of FSI “SID & GP” of the Russian Ministry of Industry and Trade
- Representative of the Russian Ministry of Industry and Trade
- Representative of the Russian Ministry of Health
- Representative of the Federal Service of Surveillance in Healthcare
- Representative of the Eurasian Economic Commission
- Representatives of the Eurasian Economic Union’s regulatory authorities
- Representatives of the European Union’s regulatory authorities
- Representative of the Russian Direct Investment Fund
- Representatives of foreign drug regulators
- Representatives of pharmaceutical companies and industry associations
- Pressing issues pertaining to the integration within the single pharmaceutical market of the EAEU
- Review of current changes in the laws and regulations
- New level III documents
- Inspection procedure in accordance with the EAEU rules (as part of the registration procedures and on the request of the national Ministry of Health) and regulators’ experience in conducting inspections of drug manufacturing
- Issues regarding the maintenance of the EAEU register
- Pharmacopeia of the Eurasian Economic Union
- , Deputy Director of Department of Pharmaceutical and Medical Industry Development, Russian Ministry of Industry and Trade
- , Head of Division for Coordination of Activities in the field of circulation of Drugs and Medical Devices, Technical Regulation and Accreditation Department of the Eurasian Economic Commission
- Representative of the Russian Ministry of Industry and Trade
- Representative of FSI “SID & GP” of the Russian Ministry of Industry and Trade
- Representative of the Russian Ministry of Health
- Representatives of Eurasian Economic Union’s regulatory authorities
- Representative of the European Commission
- Representative of the he Institute of Legislation and Comparative Law under the Government of the Russian Federation
- The need for enhancing systems of domestic pharmaceutical developments
- Compliance with GMP rules during the drug’s development phase
- Technology transfer. Scaling- up of manufacturing.
- Development of the domestic full manufacturing cycle: objectives, opportunities and perspectives
- System of state reference standards in Russia
- Main phases of drug development: active pharmaceutical substance, preclinical studies, clinical studies, registration, manufacturing
- Representative of the Russian Ministry of Industry and Trade
- Representative of FSI “SID & GP” of the Russian Ministry of Industry and Trade
- Representative of LLC “National Centre of Reference Standards”
- Representatives of industry communities and associations
- Representatives of the pharmaceutical companies
- GLP regulatory issues: laboratories and testing centres
- New regulatory elements in in GCP
- Legal and organization issues of GDP regulation
- Dietary supplements: relevant regulatory issues
- , Director of R&D center, Geropharm
- , Executive Director Union of Professional Pharmaceutical Organizations (SPFO)
- Representative of the Russian Ministry of Industry and Trade
- Representative of the FSI “SID & GP” of the Russian Ministry of Industry and Trade
- Representative of the Russian Ministry of Health
- Representatives of the Eurasian Economic Union member states
- Representatives of R&D centers
- Representatives of pharmaceutical companies
- Representatives of industry associations, including association of the manufacturers of dietary supplements
- Representatives of distribution companies
- Regulation of inspection of manufacturers of drugs for veterinary use under EAEU rules
- Experience of inspecting European manufacturers of veterinary drugs
- Representative of the Federal State Budgetary Institution «The Russian State Center for Animal Feed and Drug Standardization and Quality»
- Representative of the FSI “SID & GP” of the Russian Ministry of Industry and Trade
- Representative of the Russian Ministry of Agriculture
- Representatives of the Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor)
- Representative of the European Commission
- Representatives of veterinary drugs manufacturing companies
- Foreign markets review. Potential and opportunities of Russian pharmaceutical manufacturers for exporting their products
- Challenges and ways to overcome them in generating export opportunities for Russian companies: issues related to the compliance with international standards and requirements
- Preparation of the registration dossier
- Passing foreign GMP inspections. Experience of the leading Russian companies
- , Director of Department of Pharmaceutical and Medical Industry Development, Russian Ministry of Industry and Trade
- of the Association of Pharmaceutical Manufacturers of the Eurasian Economic Union
- Representative of the Russian Ministry of Industry and Trade
- Representative of FSI “SID & GP” of the Russian Ministry of Industry and Trade
- Trade representatives of the Russian Federation abroad
- Representatives of the pharmaceutical companies
- Representative of the European Union
- Representatives of the member-states of the Eurasian Economic Union
- Representative of FSI “SID & GP” of the Russian Ministry of Industry and Trade
- Representative of the Russian Ministry of Industry and Trade
- Representatives of foreign drug regulators
- Representatives of foreign drug manufacturers
- Representatives of FSI “SID & GP” of the Russian Ministry of Industry and Trade
- Representatives of pharmaceutical companies
President of NPO Petrovax Pharm
Director for Strategic Alliances, Russia and CIS MSD Pharmaceuticals
Communications Director, The Society of Professional Pharmaceutical Organizations
Chairman of the Board of the Eurasian Economic Union Association of Pharmaceutical Manufacturers
Executive Director for business development and external relations of MSD in Russia
Amin Hussain Al Amiri
Assistant Undersecretary of Public Health Policy and Licensing, UAE Ministry of Health and Prevention, “Preparedness of health systems for the pandemic: the UAE experience”
Head of the Department of Government Regulations of Medicines Circulation, Ministry of Health of the Russian Federation
Head of the Department for State Quality Control of Medical Products of the Federal Service for Surveillance in Healthcare (Roszdravnadzor) "Regulatory requirements for laboratories conducting preclinical studies of medicines"
Data Culture project leading expert, National Research University “Higher School of Economics”
Head of Influenza Drugs Division, St. Petersburg Research Institute of Vaccines and Serums and the Bacterial Preparation Factory” of the Russian Federal Biomedical Agency
Data Culture project manager, National Research University “Higher School of Economics”
Director of Quality Management Department of "NANOLEK" LLC
Chief editor, Vedomosti &
Mr. Deon Poovan
Senior Manager Inspectorate, The South African Health Products Regulatory Authority (SAHPRA)
Trade Representative of Russian in Netherlands
Global Head and Executive Director, GRACS CMC – Policy, MSD, “ICH Q13 and technological solutions “continuous manufacturing”
Minister Counsellor for health and agriculture at the EU Delegation to the Federation of Russia, «The pandemic COVID -19 in the European Union: lessons learned»
Regulatory Affairs Advisor, The Central Drugs Standard Control Organisation (CDSCO) “Potential for API manufacturing”
Director of Quality and External Affairs, Amgen, Switzerland
Health Policy Analyst, OECD Health Division, “Medicine shortages: the global situation and impact of the COVID-19 global pandemic”
Head of Inspectorate, Agency for medicinal products and medical devices Bosnia and Herzegovina “New formats of GMP-inspections”
Ljubica Hodak Buri
GMP Inspector Expert , Agency for medicinal products and medical devices of Croatia “New formats of GMP-inspections”
Luis Ignacio Perez-Ordoyo
GMDP inspector, Spanish Agency of Medicine and Sanitary Products (AEMPS)
Deputy Director, Pharmaceutical Quality Division, Pharmaceutical Safety Bureau, Ministry of Food and Drug Safety (video-presentation)
Marla A. Phillips
Director, Xavier Health, Xavier University (USA)
Drug Directorate Director, Jordan Food and Drug Administration (JFDA) “New formats of GMP-inspections”
Vice-President for Government Relations of "Pharmasyntez" company “Development prospects of local manufacturing of a wide range of pharmaceutical substances in the Russian Federation”
Head of the Validation Department of Labpromengineering LLC “New European guidelines on quality of water treatment: should EAEU guidelines be updated?”
Head of Public Relations, Geropharm “Main criteria for forming the government strategy for the development of national substances manufacturing”
Leading Specialist of the Good Practices Division, State Institute of Drugs and Good Practices
GSM Chemical «Case study. Development of CM for API manufacturing” “Case study. Development of CM for API manufacturing”
Deputy Director of the Technical Regulation and Accreditation Department of the Eurasian Economic Commission
Mohammed Ali Dahhas
Executive Director of Inspection Support, Saudi Food and Drug Authority “Regulator’s perspective in relation to introducing modern technologies”
General Director of "Exacte Labs" Ltd.
Deputy Head of the Coordination Division in the Sphere of Medicines and Medical devices circulation, Technical Regulation and Accreditation Department, the Eurasian Economic Commission (EEC), “Balance of the Eurasian and national requirements: hierarchy of norms and transitional periods”
Head of the Medical Products Registration Department of Novo Nordisk
Director, Office of Manufacturing Quality for Drugs, Pharmaceutical and Medical Devices Agency (PMDA) of Japan, “GMP Inspection under the covid-19 pandemic in Japan”
Marketing and Business Development Director, Long Sheng Pharma Rus LLC
Head of Quality and Compliance Division, Roche company, Movie-clip about online inspections
Deputy Director, Head of Registration Department of the Gedeon Richter Representative Office
Head of Drug Manufacture Inspections Department, Federal State Institution "State Institute of Drugs and Good Practices
Senior Quality Specialist, Analytical Expertise Center Ministry of Health - Azerbaijan Republic
Counsellor to the General Director for Quality, Scientific Research Institute of Physics and Chemistry named after L.Y. Karpov (Rosatom)
Deputy Head of Section for Good Practices, State Institute of Drugs and Good Practices
Head of the Oncological Medicines Division of the Global Registration Department СМС Novartis “CM in the context of pharmaceutical innovations, and also challenges and opportunities from the perspective of industry/regulator”
General Director of "Center of Pharmaceutical Analytics"
General Director of Veltrrade (Welpharm)
Head of the Manufacturing Site Inspection Directorate, Egyptian Drug Authority (EDA), Ministry of Health and Population (MOHP)
President of National Institute of Hygiene "Rafael Rangel" of Venezuela
Deputy minister of Resources, Technology and Regulation of Venezuela
Deputy Director, JSC National Engineering Corporation
Manager for registration of the Department for registration, Gedeon Richter
Director, Scientific Centre for Expert Evaluation of Medicinal Products (SCEEMP) of the Ministry of Health of the Russian Federation
Country Head, Sun Pharmaceuticals Russia
Psychotropic coordinator, Autonomous Health Service Comptroller (SACS), Venezuela
Executive Director, Product Quality, Amgen, USA
Deputy Director on foreign economic activities , Infamed K
Corporate Vice President, Quality Intelligence and Inspections, Novo Nordisk A/S
Deputy director, Center for Examinations and Tests in Health Service, The Republic of Belarus
Branch Director, «Zavod «Medradiopreparat», the branch of FSUE «Federal center of nuclear medicine projects design and development» of FMBA of Russia
Deputy Head of Expertise Department, Federal State Institution State Institute of Drugs and Good Practices
Steven A. Karli
Inspection and Compliance. Center for Veterinary Biologics, United States Department of Agriculture
Director of R&D Center, Geropharm
Doctor of Medical Sciences, Professor, Director of the Research Institutes Group
Senior Specialist of Department on Drug Product Inspection, Federal State Institution "State Institute of Drugs and Good Practices"
Head of the Good Practices Division, State Institute of Drugs and Good Practices “Experience of conducting GMP audits”
Lead Specialist of Department on Drug Product Inspection, Federal State Institution State Institute of Drugs and Good Practices of the Ministry of Industry and Trade of the Russian Federation
Global quality director, Dechra/HALMED, Croatia
Deputy Head of Department on Drug Product Inspection, Federal State Institution State Institute of Drugs and Good Practices of the Ministry of Industry and Trade of the Russian Federation
Pharmacist, GMP Chief Inspector, Food and Drug Administration (TFDA), Thailand
Director of Legal and HR Department, PHARMIMEX JSC
Director, Ivanovo Regional Blood Transfusion Station
Technical Director, Head of the Representative Office of JSC Kedrion S.p.A.
Chairman of the Board of Directors, Immuno-Gem LLC
Head of Quality Service, PhD in Medical Sciences, the Federal State Budgetary Institution of the Russian Medical Center Rosplasma Federal Medical and Biological Agency
Deputy General Director for Medical Activity of the Federal State Budgetary Institution of the Russian Medical Center Rosplasma Federal Medical and Biological Agency
Head of the Blood Service Department of the Federal Medical and Biological Agency (FMBA)
Senior legal officer, law firm Egorov Puginsky Afanasiev & Partners
Director, LLC Gringo
Senior Research Fellow of section for administrative law and administrative procedure Institute of Legislation and Comparative Law under the Government of the Russian Federation
Senior Research Fellow of section for administrative law and administrative procedure Institute of Legislation and Comparative Law under the Government of the Russian Federation
Head of the Department of Social Legislation, Institute of Legislation and Comparative Law under the Government of the Russian Federation
Head of Legal Department, Federal State Institution "State Institute of Drugs and Good Practices" of the Ministry of Industry and Trade of the Russian Federation
Head of the medical department, Infamed K
Chairman of the Coordination Council, National Association of manufacturers of pharmaceutical products and medical devices
General Manager R&A Russia & CIS, Life Science, MERCK
Inspector of manufacturers and distributors of veterinary medicinal products (VMP), The French Agency for Veterinary Medicinal Products (ANMV)
Adviser to General Director, JSC Rusatom Healthcare
Head of section for government relations, Takeda
Managing Director, Cursor Marketing
Vice-chancellor, Vladivostok State Medical University of the Ministry of Health of the Russian Federation
Chief clinical pharmacologist of St. Petersburg, President of Professional Medical Association of clinical pharmacologists of St. Petersburg
First deputy chairman of the government Председателя of the Kirov region
Minister of Heatlh of the Kaliningrad region
Division Director for Quality and Compliance, Abbott Pharmaceuticals Division “Modelling of aseptic process with the use of digest medium”
CEO and Founder, No Deviation, Singapore
Marta de Vicente
Pharmaceutical Inspector, Inspection Area, Pharmaceutical Inspection and Enforcement Department, Spanish Agency of Medicine and Sanitary Products (AEMPS)
GMP Inspector Expert, Croatian Agency for Medicinal Products and Medical Devices (HALMED)
Head of the Manufacturing Site Inspection Directorate, European Directorate for the Quality of Medicines (EDQM), France
Soren Thuesen Pedersen
Senior Director, External Affairs, Quality Intelligence and Inspection, Novo Nordisk A/S
GMP Inspector, Italian Medicines Agency (AIFA)
Quality Director, Russia and Eurasia. Teva
Deputy Chief Medical Officer for Prospective Development, State Budgetary Institution Konchalovsky City Clinical Hospital of Moscow City Health Department (Konchalovsky Clinic)
Discipline Engineer. Engineering & Maintenance, Bilfinger Tebodin CIS B.V.
Chief Quality Assurance Officer, JSC Pharmasyntez
specialist of the Engineering and Design Division, State Institute of Drugs and Good Practices
Jens Peter Gundorf
Principal Specialist, Validation, Novo Nordisk A/S, Denmark
Senior Director Global Accounts, Werum IT Solutions GmbH
Head of Emerging Markets Region Regulatory Department, GlaxoSmithKline
Head of the Department for Industrial Pharmacy, I.M. Sechenov First Moscow State Medical University, Member of the Council for professional qualifications in pharmacy
Deputy Director of the Centre for Expertise and Control of Medicinal Products of the Federal State Budgetary Institution Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation. “Pre-registration expertise of Module 3 "Quality" set of documents”
Director, St. Petersburg Scientific Research Institute of Vaccines and Serums (SPbSRIVS)
General Director, MECHNIKOV Institute
Goranka Marušić Kontent
European Affairs Counsellor, Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
Inspectorate Head, National Institute of Pharmacy and Nutrition (OGYÉI)
Deputy Drugs Controller of the Central Drugs Standard Control Organization (CDSCO) of India
Executive Vice President, Teva
General Director, Roche Moscow
Chief Executive Officer, Pharmstandard JSC
Senior Director for manufacturing/quality and compliance, Pharmaceuticals and Medical Devices Agency (PMDA) of Japan
Rafael Pérez Cristiá
Director General of Cuba’s Center for State Control of Medicines and Medical Devices (CECMED)
Director of the ISPE Eurasian Affiliate
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.
Head of the Training and Development Division of the Pharmaceutical Inspectorate, State Institute of Drugs and Good Practices “The Academy of Inspectorates as a resource for ensuring expert and narrowly specialized education in the field of GxP”
Candidate of Pharmaceutical Sciences.
Advanced trainings in the production and quality control of drugs. Advanced trainings in GMP/GDP inspection/audit.
2006 – 2016 Ivan worked in the positions of the R&D project-manager, Lecturer, Production Technologist, Head of an Analytical Laboratory, Head of the Quality Control department.
2016 – till present – Head Specialist of Department for Inspection of Pharmaceutical Production of the State Institute of Drugs and Good Practices. Since 2017 Ivan began to combine the main activities with the work of the facilitator of GMP-courses.
Executive Director, Quality Sciences Amgen, Inc.
Kris Evans is currently the executive director of Quality Sciences at Amgen, where his team helps ensure that the company is science- and risk-based in their quality activities, including critical investigations, regulatory inspections and operating standards. In 2007, Mr. Evans retired from the US Food and Drug Administration after serving for twenty (20) years as a Field Investigator and later in CDER’s Office of Compliance on the Guidance and Policy Team. While at FDA he conducted biopharmaceutical inspections worldwide, specializing in sterile manufacturing operations. He also helped draft many GMP guidance and policy documents, primarily on aseptic processing, sterilization and validation. Mr. Evans also served on the PDA Science Advisory Board and has been an active contributor to several PDA Technical Reports. He holds a B.S.E. degree in Biomedical Engineering from Duke University.
Director of Innovation of CJSC “Innovational production Technopark “Idea”.
Born: 27 September, 1965 in Kazan
In 1989, graduated from the Kazan State Technical University named after A.N. Tupolev, radio engineering sub department, speciality of radio-electronic systems.
1988 -1992. – design engineer at KOMZ, Central design Bureau «PHOTON».
1992 -2004 – head NPF «Sitek».
2004 – 2005: CEO of Informatization Center of the Republic of Tatarstan under the Cabinet of Ministers of RT.
2005 – 2006 – First Deputy Minister of Informatization and Communication of the Republic of Tatarstan.
2006 – 2018-Director of Innovation of CJSC “Innovational production Technopark “Idea”.
Since July, 2018 – General Director of JSC ” IPT ” Idea”
General Director of JSC «Tatchempharmpreparaty»
Was born in Kazan. Education-faculty of law of Kazan state University, specialty «jurisprudence» (2003). Kazan national research technological University on the specialty «chemical technology of organic substances» (2014).
- From 2002 to 2007 – General Director of «Madambakkam».
- From 2007 to 2008 – General Director of LLC «Medopt».
- From 2008 to 2009 – Assistant of the General Director of JSC «Tatchempharmpreparaty».
- March 2009 – General Director of JSC «Tatchempharmpreparaty».
He is married and has two children.
Rector of the Federal State Budget Educational Institution of Higher Professional Education ''Kazan State Medical University''.
Date of birth: 31st of December, 1963, in Kazan city.
In 1987 he graduated from the Kazan State Medical Institute named after S.V.Kurashov (medical case).
In 1987 – doctor-therapist at the Tetyushinsky central district hospital.
From 1987 to 1989 – residency training at the Department of Infectious Diseases of KSMI.
From 1989 to 1992 – postgraduate studies at the Department of Infectious Diseases of KSMI.
From 1992 to 1994 – Assistant Professor of the Department of Infectious Diseases of the KSMU.
From 1994 to 1996 – Associate Professor of the Department of Infectious Diseases of the KSMU.
From 1996 to 2003 – vice-rector for academic affairs of the KSMU.
From 2002 – work as part of the personnel council of the Ministry of Health of the Republic of Tatarstan.
From 2003 to 2009 – Head of the Department of Biomedics and Medical Law of KSMU.
From 2003 – Chairman of the Ethics Committee of the Ministry of Health of the Republic of Tatarstan.
From 2006 – member of the Russian Committee on Bioethics under the Commission of the Russian Federation for UNESKO, chairman of the forum of ethics committees of CIS countries.
From 2007 – Chairman of the Forum of Ethical Committees of CIS countries.
From 2009 – Rector of Kazan State Medical University.
From October 2014 – Deputy of the State Council of the 5th convocation.
Doctor of Medical Sciences, Professor.
Member of the editorial boards of the journals ”Bioethics” (Volgograd), ”Medical Law” (Moscow), ”Kazan Medical Journal”, ”Neurological Herald” (Kazan).
Was awarded the medal “For Labor Distinction” (1986).
Director of the Federal State Budgetary Scientific Institution "National Research Institute of Public Health named after N.A. Semashko»
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.
Deputy Minister of Industry and Trade of the Republic of Tatarstan
Date of birth: 18th of February, 1966, in the village of Bolshie Tarkhany of the Tetyush District, TASSR.
Kazan State University, Honors Diploma (1989),
Kazan State Technological University, Honors Diploma (2003)
03.2001 – 11.2011- Director of the branch, General Director of LLC “Phosphoros” in Kazan
05.2012 – 03.2013 – General Director of CJSC “Microbor-Nanotech” (Rosnano Corporation)
03.2013 – 06.2016 – Deputy General Director of “ROSTEKO LLC”, Member of the Board of Directors for “KAMENT” Group of Companies, co-founder of numerous commercial firms.
06.2016 – up to the present – Deputy Minister of Industry and Trade of the Republic of Tatarstan.
The author of multiple scientific inventions, publications and articles; laureate of the State Prize of the Republic of Tatarstan in the field of science and technology.
Minister of health of the Republic of Tatarstan
Date of birth: 27th of January, 1970, in Buinsk city.
Graduated from Kazan state medical Institute with a degree in “Pediatrics”. (1993)
From June 2008 to February 14th, 2018 – Chief Physician of Municipal Clinical Hospital “City Clinical Hospital No. 7”.
From 2009 to 2014 – Deputy of the State Council of the Republic of Tatarstan.
From October 2014 to February 20th, 2018 – Deputy of the State Council of the Republic of Tatarstan of the 5th convocation.
From 14th of February, 2018 – Minister of health of the Republic of Tatarstan.
Candidate of Medical Sciences. Honored Doctor of the Republic of Tatarstan. The organizer of public health services of the highest category.
Was awarded with a badge “Honored worker of public health services”.
Laureate of the State Prize of the Republic of Tatarstan in the field of science and technology.
Member of the political party “United Russia”, a member of the faction “United Russia” in the State Council of the Republic of Tatarstan.
Member of the Committee of the State Council of the Republic of Tatarstan on social politics.
Chief Executive of the Tatarstan Investment Development Agency
Born: 24 April 1985 in Kazan
2002-2007 Kazan Federal University, foreign languages, first-class degree diploma. Chairman of the Student’s Council (Kazan city, Tatarstan, Russia).
2008-2009 МВА Program (General Management) at Kazan Federal University
2012-2013 МВА Program (HR) at State University of Great Britain в (Sunderland city, England) full-time program. First-class degree diploma.
Graduated from School of Public Policy under National University of Singapore (Singapore), Civil Service College of Singapore (Singapore), Business School of Management “Skolkovo” (Moscow, Russia), Russian Academy of National Economics and Public Administration under the President of Russia (Moscow, Russia), Corporate University of Sberbank (Moscow, Russia), Stanford University, Canada School of Public Service (Toronto, Ottawa, St.John’s cities) and other.
2007-2010 Ministry of Economy of Tatarstan Republic (specialist in Investment Department, leading advisor, leading consultant, Head of Department)
2010-2014 Administration of the President of Tatarstan Republic (Head of Division, Head of Department of Civil Service Development)
2014-till now Government of Tatarstan Republic (Head of Tatarstan Investment Development Agency)
Swimming, piano playing, reading, classical music.
Министр промышленности Республики ТатарстанDeputy Prime Minister of the Republic of Tatarstan - Minister of Industry and Trade of the Republic of Tatarstan
Born: 23 January 1976 in Kazan
In 1997, graduated from the Kazan Financial and Economic Institute (economic theory, economist)
In 2000, the Kazan State Institute of Finance and Economics (postgraduate)
In 2009, the Oxford University (MBA Programme)
1996 – 1998 – Head of Bill Circulation Group at TDT-Invest Investment Company
1998 – 2001 – Director General, Executive Director of TDT-Invest Investment Company
2001 – 2004 – Aide to the First Deputy Prime Minister of the Republic of Tatarstan
2004 – 2015 – Director for Economics and Finance, First Deputy Chairman of the Board at Idea Investment and Production Technopark
2006 – 2010 – Director General of Idea Capital Managing Company
2010 – 2015 – Chairman of the Supervisory Board at Idea Capital Managing Company, Chairman of the Board at OAO Himgrad
Since November 23, 2015 – Acting Deputy Prime Minister of the Republic of Tatarstan and Minister of Industry and Trade of the Republic of Tatarstan
Since December 23, 2015 – Deputy Prime Minister of the Republic of Tatarstan and Minister of Industry and Trade of the Republic of Tatarstan
PhD (Candidate) of Economic Sciences
Has a good command of English and German
Honoured Economist of the Republic of Tatarstan (2014)
Director of the Department for pharmaceutical and medical industry development, Ministry of Industry and Trade of the Russian Federation
2008 – Moscow Lomonosov State University. Institute of Asian and African Studies, cum laude.
2009 – worked in the of the State Duma of the Federal Assembly of the Russian Federation, Committee for CIS Affairs and Relations with Compatriots
2010 – headed the clinic of restorative medicine in Moscow
2010-2013 – led the Asia-Pacific direction of CJSC Biocad
Since 2014 – held executive positions in the Department of Pharmaceutical and Medical Industry Development of the Ministry of Industry and Trade of the Russian Federation
In 2017 – appointed Director of the Department of Pharmaceutical and Medical Industry of the Ministry of Industry and Trade of the Russian Federation
In 2014 he was awarded the gratitude of the Minister of Industry and Trade of the Russian Federation.
Speaks English and Chinese
Married, has a son
Director of the Department for Medicines Accessibility and Regulation of Medical Devices Circulation
In 1984 she graduated from the faculty of pharmacy of the First Moscow medical Institute.
- Since 1984 she worked at the Institute as a senior laboratory assistant (1986-1989), senior lecturer (1989-1993), associate Professor (1993-2005), Professor of the Department of organization and Economics of pharmacy of the faculty of pharmacy (2005-2006), head of the Department of management and Economics of pharmacy (2007), Dean of the faculty of postgraduate professional education of pharmacists (2005).
- Specialist in management and Economics of pharmacy, doctor of pharmaceutical Sciences, Professor.
- Author of the first dissertation in the field of marketing research in the pharmaceutical market of Russia, one of the founders and editors-in-chief of the professional pharmaceutical journal “Cedevita” (2003-2004).
- Since 2005 is the editor-in-chief of the professional pharmaceutical magazine “the First Table”.
- Since 2007 – member of the international pharmaceutical organization FIP.
- In July 2013 she was appointed assistant Minister of health of the Russian Federation.
- in October 2013 she was appointed Director of the Department of drug supply and regulation of medical devices of the Ministry of health of Russia.
Deputy Head of the Federal Service for Surveillance in Healthcare (Roszdravnadzor)
Higher, Candidate of pharmaceutical Sciences. Graduated from Pyatigorsk pharmaceutical Institute, faculty of pharmacy, specialty pharmacist-analyst.
- She has experience in teaching, practical experience in managerial positions of control and analytical laboratory, organization-manufacturer of medicines, the state civil service.
- Awarded the medal «In memory of the 850 anniversary of Moscow» Administration of the Moscow region.
- Has the honorary title «Honored worker of health of the Russian Federation».
Deputy Director of the Department for pharmaceutical and medical industry development
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.
Director of the FSI ‘State Institute of Drugs and God Practices’
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”
Doctor of medical Sciences, General Director of FSBI «SCEMD» Ministry of health of Russia
In 1984 he graduated with honors from the Military medical Academy. S. M. Kirova, in 1989 – clinical residency of the same educational institution in the specialty «Urology», also in 2008 the Russian state medical University of Roszdrav in the specialty «Organization of health care and public health».
- 1984-1987 – Head of the medical service of the nuclear submarine of the Northern fleet. A participant 5 distant hikes.
- 1987-1989 – Clinical resident of the Department of urology of the Military medical Academy. S. M. Kirov.
- 1989-2008 – Service in the Central military clinical aviation hospital No. 7 of the Ministry of defense of the Russian Federation (Moscow) in positions Junior, senior researcher, senior resident, head of the urological Department, head of the urological center – leading urologist of the hospital. Doctor of the highest qualification category in the specialty «Urology». Honored doctor of the Russian Federation. Colonel, medical service reserves.
- 2008 – Chairman of the Committee for public health protection of the Novgorod region.
- 2008-2009 – Minister of health of Irkutsk region.
- 2010-2012 – Advisor to the Governor of the Samara region.
- 2012-2013 – Deputy General Director of RT-Biotechprom.
- 2013-2015 – General Director of RT-Biotechprom.
- Since April 8, 2015 – acting General Director of FSBI «SCEMD» of the Ministry of health of Russia.
- Since November 3, 2015 – General Director of FSBI «SCEMD» Ministry of health of Russia.
Doctor of medical Sciences, scientific rank-senior researcher, author of 220 publications, 3 inventions, prepared 4 candidates of medical Sciences.
He was awarded the order of Honor, medals: «70 years of the armed Forces of the USSR», «300 years Of the Russian Fleet», «In memory of the 850th anniversary of Moscow», Zhukov and other departmental Soviet and Russian medals.
Head of the Moscow Department for Science, Industrial Policy, and Entrepreneurship
In 1997 he graduated From the state University of land management in Moscow.
From 1997 to 2001 he studied at the Russian Academy of public service under the President of the Russian Federation.
- From 1997 to 1998-a leading specialist in the Department of Federal lands of the Department of land relations reform of the State Committee of the Russian Federation for land resources and land management.
- Since 1998-chief specialist of the Department of Federal lands of the Department of land policy of the Ministry of the Russian Federation for land policy, construction and housing and communal services.
- From December 1998 to August 2000-chief specialist of the Department of Federal lands of the Department of state and municipal lands, was an adviser, Deputy head of the Department of state lands of the State Committee of the Russian Federation on land policy.
- Since 2000-the head of Department of legislative works of Management of land reform, worked as the Deputy head of Department of land reform. Until 2004 he worked as the head of the Department of legislative works and regulatory and methodological support of the Department of land policy of the Ministry of property relations of the Russian Federation.
- From 2004 to 2007-Deputy head of real estate And movable property of the Federal Agency for Federal property management.
- From 2007 to 2008-Deputy General Director for the delimitation of state ownership of land and regional development In the Directorate of Federal state unitary enterprise «Federal computer center of stock and commodity information technologies (FT-Center)».
- Since 2008-head of the Department of land resources and real estate. Until October 2015, he held the position of first Deputy General Director of the Federal Fund for housing development («Fund «RZHS»).
- In September 2016, he was appointed first Deputy head of the Department of science, industrial policy and entrepreneurship of Moscow.
- In February 2017, he was appointed head of the Department of science, industrial policy and entrepreneurship of Moscow.
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”).
Regional Director Country Management Novartis CEE and CIS Country President Novartis Group in Russia
Vadim Vlasov has been Country President of Novartis Group Russia since September 2010. In this role he is accountable for the local business operations management, interaction with external stakeholders, coordination of Novartis divisions and business units in Russia, the company reputation maintenance and development. In addition to that, as of 2018 Vadim has become Regional Director of CEE and CIS region, responsible for country management governance in Bulgaria, Croatia, Czech Republic, Hungary, Israel, Poland, Romania, Slovakia, Slovenia, Ukraine, Latvia/Baltics and CIS countries.
Prior to joining Novartis in 2003-2010 Mr. Vlasov occupied the position of Head of EADS/Airbus in Russia.
Previously, Mr. Vlasov served as Head of Siemens Medical Solutions and Country Manager of Acuson Corporation in Russia and CIS.
Mr. Vlasov has a Degree of Mechanical Engineer (with honours) from Moscow Aviation Institute and completed Advanced Development Program at London and Harvard Business Schools.
CEO (General Director) of pharmaceutical company NovaMedica
Alexander has dedicated more than 20 years of his life to development of the Russian pharmaceutical industry. Before NovaMedica, Alexander was First Deputy CEO at the Rigla pharmacy chain, one of the largest players on the Russian market. He was responsible for sales, procurement, logistics, the marketing and development of the company. Previously from 2004 to 2009 he headed DSM Group, one of the largest marketing and analytical agencies on Russia’s pharmaceutical market. From 1996 to 2003 Alexander held different positions in marketing and advertising at the pharmaceutical company Protek Group.
Alexander is also a member of the Coordination Council of the Russian Association of Pharmaceutical Marketing.
In 2012, 2013, 2014 and 2017 the Association of Russian Managers listed Alexander Kuzin in the Top 1,000 Rating of Russian Managers, in 2017 he was listed also in the Top 250 CEO as a CEO of NovaMedica.
Alexander has won on several occasions Platinum Ounce, a national award in the pharmaceutical industry: he received a Press Acknowledgement nomination in 2007, and Functional Management nomination in 2012.
Alexander graduated in 1996 from Moscow Physical Engineering Institute with a degree in Physical Engineering and obtained an MBA degree in 2012.
Rector, Doctor of Pharmaceutical Sciences, Professor.
Federal State Budget Educational Institution of Higher Education “Saint-Petersburg State Chemical and Pharmaceutical University” of the Ministry of Health of the Russian Federation (FSBEI SPChFU of the Ministry of Health of Russia)
He was born October 29, 1966 in the city of Vitebsk.
Graduated with honors from the Military Medical Faculty of the Tomsk Medical Institute. In 1993 he defended his Ph.D., in 2001 – his doctoral dissertation on the specialty “medicine technology and organization of pharmaceutical business”. Narkevich is dedicated to solving the problems of forecasting the need for medicines and medical products in conditions of uncertainty, as well as the management of multi-level supply systems.
He developed the theoretical foundations and methodology for the formation of reserves that ensure the optimal level of the need for defense and law enforcements in medical assets.
Developed and takes part in the implementation of the basic educational programs of Secondary and Higher professional education in pharmacy, chemical and biotechnology. He initiated and implemented educational projects with the leaders of the world pharmaceutical industry – Pfizer, Novartis, MSD, Eli Lilly, Sartorius, aimed at training highly qualified personnel for the Russian pharmaceutical industry.
A recognized expert in the field of medical and pharmaceutical commodity science, the organization of pharmaceutical assistance in large multi-disciplinary medical and preventive institutions and the provision of medical equipment to law enforcement agencies.
He is the author of more than 160 scientific and methodical works, including textbooks on medical and pharmaceutical commodity science; management and economics of pharmacy. Under his leadership, 10 PhD dissertations and 2 doctoral dissertations were defended.
Igor Narkevich is the coordinator of the NTS “Pharmacy of the Future”, and is also a member of the following councils:
- Coordinating Council for the Development of the Pharmaceutical Cluster in St. Petersburg under the Government of St. Petersburg (Decree of the Government of St. Petersburg of December 15, 2010 No. 1692;
- Medical Council under the Governor of St. Petersburg (Governor of St. Petersburg Decision No. 37-pg of 22.06.10);
- Working group on activity 2.5. “Preclinical research of innovative medicinal products” and 5.2.2. “Creation of new educational programs and educational modules for higher and secondary professional educational institutions” FTP “Pharma-2020” under the Ministry of Education and Science of the Russian Federation.
He was awarded the medal of the Order of Merit for the Fatherland of the II degree, the Mark – “Honorable Healthcare professional”, the Ministry of Internal Affairs of the Russian Federation “For Distinction in Service”, the medals “200 Years of the Ministry of Defense”, I degree “For Faith and the Fatherland”, Silver Medal – Admiral M.P. Lazarev and others.
Rector of the Kazan Federal University
Ilshat Rafkatovich Gafurov (born August 1, 1961, Bavly (TASSR)) — a well-known figure of Russian higher education, rector of the Kazan Federal University since 2010. Public politician, deputy of the State Council of the Republic of Tatarstan since 1995, chairman of the Council of Rectors of the Republic of Tatarstan since 2010.
Ilshat R. Gafurov was born in a family of employees. In 1978 he graduated from the secondary school in Yelabuga and entered the Physics Department of Kazan State University, which he graduated in 1983.
After graduating from the university, he worked as a research associate at the General Physics Department of the Elabuga State Pedagogical Institute (later Elabuga State Pedagogical University, now a branch of the Kazan Federal University (KFU) in Elabuga). In 1985 he entered full-time postgraduate study at the Department of Molecular Physics (now the Department of Physics of Molecular Systems), Kazan University.
In 1988 he returned to the Elabuga State Pedagogical Institute, where he began to work as a senior teacher, and in 1989 he defended his PhD thesis in the field of polymer physics.
In 1997, he graduated from the Kazan Financial and Economic Institute with a degree in Management and began to engage in scientific research in a field of economic theory and practice.
On April 9, 2010, Ilshat Rafkatovich was elected as Rector of KFU.
- PhD in Physical and Mathematical Sciences, 1989.
- Doctor of Economic Sciences, 2005.
- Professor, 2006;
- Corresponding Member of the Russian Academy of Education, 2016;
- Full member of the Academy of Sciences of the Republic of Tatarstan, 2017.
Doctor of pharmacy, professor
Pharmacist, Pharmaceutical State University, Pyatigorsk
Appointments: Doctor of pharmacy, professor
Director of center of educational programs of the Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health of the Russian Federation (FSBI “SCEEMP” of the Ministry of Health of the Russian Federation)
Head of department of medicinal provision organization and pharmacoeconomics of the 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)
President of the Moscow Pharmaceutical Society
Chief editor of the journal:
«Pharmacoeconomics: theory and practice»
«Modern organization of drugs supply »
Chair of Advisory Board of the journal «New Pharmacy»
Expert of Higher Attestation Commission
Expert of Russian Academy of Science (RAS)
Member of I.M. Sechenov First Moscow State Medical University
Executive Director of Innovative Pharma Business Association
International University (Moscow), faculty of law.
In 2012, Vadim Kukava was invited to the position of Executive Director Of the Association of the world’s leading innovative pharmaceutical companies «Infarma». During this time, the Association has become a significant player in the Russian pharmaceutical market, interacting with government authorities to develop a balanced regulation of the industry for the benefit of Russian patients.
From 2006 to 2012, Vadim worked in the largest international companies producing consumer goods, in positions on public relations and public authorities. During this period, Vadim participated in the discussion of key legislative acts in the sphere of regulation of tobacco and medical industry, interacted with representatives of Russian and European scientific community, took an active part in the work of industrial associations, including the Board. In addition, in one of the companies Vadim was responsible for the creation and development of the Department of public relations and state authorities.
From 2004 to 2006 he worked as a consultant in the Federal Agency for Federal property management (Rosimushchestvo). Vadim was responsible for the implementation of the full range of the owner’s powers in relation to the property of the timber and chemical industry owned by the Russian Federation.
In 2003 he graduated from the law faculty of the International University in Moscow.
Deputy General director, Government relations, BIOCAD
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.
Senior Director of Government Affairs & Market Access, Teva
2004 Military university under support of the Ministry of Defence of the Russian Federation, Moscow, An honours degree in chemistry.
2017 Higher School of Economics, Moscow, MBA program «The pharmaceutical management».
From 2004 till 2013 held key positions at the Security Agencies of the Russian Federation.
From November 2013 worked at STADA CIS and from 2016 worked at AstraZeneca as Government Affairs Manager.
In October 2017 Andrey joined Teva as Senior Director of Government Affairs & Market Access.
Head of the Government Relations Department, GEROPHARM.
Irina Emchenko graduated from the First Moscow State Medical University named after I.M. Sechenov.
She has been working in GEROPHARM company since 2014 and is responsible for government relations.
Adviser to the Director of the FIBU "GILS and NP" of the Ministry of Industry and Trade of the Russian Federation
Sixteen years of professional experience as a personal and corporate advisor in large scale companies and government agencies; a university professor at the Peoples’ Friendship University of Russia.
Organizational and management consulting, development and methodical support of training and staff development programs.
Introduction of advanced technologies for training and development of personnel, support of the company’s restructuring , methodological support of intensive training programs, staff auditing, conducting workshops, development and implementation of internal and external communications systems, coaching of top managers, team coaching, image making and branding.
Moscow State Open Pedagogical University, major: social counselor, practical psychologist.
Russian Presidential Academy of Civil Service, major: personnel management.
International University GLOBAL COACHING: CCE Mentor, PCC ICF Coach
Director's advisor, State Institute of Drugs and Good Practices, Head of the Pharmacy Department at the Pirogov Russian National Research Medical University
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.
Deputy Scientific Director of the Scientific Centre for Expert Evaluation of Medicinal Products of the Russian Health Ministry
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).
General Director of the Association of Russian Pharmaceutical Manufacturers (ARPM).
In 1988 graduated from the Sanitary and Hygienic Faculty of the First Moscow Medical Institute named after I.M. Sechenov.
From 1988 to 1990 worked as a sanitary doctor of Sanitary and Epidemiological Station No. 4 GU at the Ministry of Health of the USSR.
In the years 1990-1996 was a junior researcher, research associate, deputy dean of the Moscow Medical Academy named after I.M. Sechenov.
From 1996 to 1999 held the positions of research officer, senior research fellow of the Russian State Center for Drug Expertise of the Russian Ministry of Health.
In 1999-2002 was Deputy Director General of the Scientific Center for Expertise and State Control of Medicines of the Ministry of Health of Russia.
From 2002 to 2004 held the post of Executive Director of the Association of Russian Pharmaceutical Manufacturers (ARPM).
In 2004-2007, worked as deputy director of the Federal State Institution “Scientific Center for Examination of Medical Applications” Roszdravnadzor.
In October 2007 – by decision of the general meeting of the ARPM was elected its General Director.
Victor Dmitriev is a member of the Board of the Russian Union of Industrialists and Entrepreneurs and is a member of the Subcommission on the circulation of medicines of the Government Commission for the Protection of Public Health, a member of the Council of the Chamber of Commerce and Industry.
Chairman of the Board of the EAEU Pharmaceutical Manufacturing Association
In 1989 he graduated From the military medical order of Lenin of the red banner Academy named after S. M. Kirov, specialty «Medicine». In 2002, he took a course on professional development on the topic «Local government: problems and development trends».
From June 2011 to the present time-Director of the Union in the field of development, production and circulation of medicines and medical equipment «Medical and pharmaceutical projects. The twenty-first century».
From January 1, 2016 to the present time he is the Chairman of the Board of the Association of pharmaceutical manufacturers of the Eurasian economic Union, which United the majority of advanced innovative companies in the field of research, development and production of pharmaceuticals of the Eurasian economic Union (Republic of Armenia, Republic of Belarus, Republic of Kazakhstan, Kyrgyz Republic and Russian Federation).
Executive Director of the Association of International Pharmaceutical Manufacturers (AIPM)
For a long time Mr. Shipkov has worked in the different governmental institutions. His career of the government employee includes, among other, the functions of the Director of Pharmaceutical Inspection of the Ministry of Healthcare of the Russian Federation, Deputy Director of the Federal Service of Intellectual Property, Patents and Trademarks (Rospatent). Mr. Shipkov also has working experience in the State Duma of the Russian Federation and State Customs Committee of the Russian Federation. Since 2007 he is heading of the Association of International Pharmaceutical Manufacturers. V. Shipkov is a Board member of the Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and the Association of the European Self-Medication Industry (AESGP).
The Association of International Pharmaceutical Manufacturers (AIPM) is the leading professional association on the Russian pharmaceutical market. AIPM was established in 1994, represents more than 60 multinational global pharmaceutical companies that account for over 80% of the global pharmaceutical production and over 60% of medicines supplied to the Russian Federation. AIPM members are both Russian and foreign pharmaceutical manufacturers. The Association is a member of respected Russian and international organizations, such as the Russian Union of Industrialists and Entrepreneurs (RSPP), the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Association of the European Self-Medication Industry (AESGP).
General Manager, Abbott’s Veropharm
Elena was appointed General Manager of Abbott’s Veropharm at February 2015. Before that, she was in charge of Cardiology and Neurology at Abbott’s Established Pharmaceuticals Division, as well as serving in executive positions in finance, corporate regulation, logistics, sales, and marketing at major pharmaceuticals companies.
Acquired by Abbott in late 2014, Veropharm is a leading Russian pharmaceuticals manufacturer. In three Abbott’ Veropharm plants, all located in Russia, we produce over 300 pharmaceutical and medical products, many of which are included in the Essential Drug List.
Abbott’s Veropharm is one of the country’s largest maker of oncology medicines and high-quality adhesive bandages in Russia. The key therapeutic areas of the company also include gastroenterology, transplantology, women’s health, dermatology and neurology as well as infectious diseases.
Elena graduated from the Moscow State Linguistic University and earned her EMBA in the US from The Fuqua School of Business, Duke University.
President, Chief Consultant Skibo Regulatory Consulting
Accomplished Regulatory Affairs executive with over 20 years of experience in the pharmaceutical/biotech industry. Leadership roles in global CMC, Quality, WW Regulatory Operations, leading global RA organization. Over 6 years of consulting supporting USA, EU, and global markets.
World-wide expert in leading global product registrations and strategy from clinical stages to the new product application and throughout the product lifecycle. Specialized in US and EU pharmaceutical law, BRIC and other Emerging Markets regulatory framework and cultural sensitivities. Fluent in Russian and Spanish.
Global GMP compliance gap assessment and inspection support including mock audits and translation services. Thorough understanding of GMPs, GLPs, GCPs and the requisite experience in resolving compliance issues in these areas.
Offer wide range of customized in-house training programs on US, EU and Emerging Markets pharmaceutical law, global GMP requirements, modern QMS design and implementation. Possess an engaging, unique, and interactive, training style with proven results and stellar feedback.
Established record of direct interactions and successful negotiations with FDA, USDA, HC, PMDA, MHRA, DVM, ANVISA, COFEPRIS, and other health authorities on compliance, regulatory strategy, and labeling areas. Experienced with diverse dosage forms, therapeutic groups, and route of administration.
Passionate advocate and active supporter of knowledge- and science-driven organization model that operate within the regulatory framework and result in an agile business model that benefits the patient and encourage Quality Culture environment. As a consultant, have an outstanding record providing compliance, training and regulatory support to a number of major pharma and biotech companies.
Specific Areas of Expertise Include:
- US and EU Pharmaceutical Law
- GMP requirements – global perspective and current updates
- Emerging Markets regulatory framework, cultural diversity, unique logistics
- CMC – new files and post approval changes
- Design of effective customized educational and training programs
- Established record of interaction and negotiation with Health Authorities
- Modern Quality System: design, implementation, continuous improvement, complete product life cycle management, quality culture elements
- Response to 483s, Warning Letters, regulatory compliance queries
- Preparation and management of NDA, BLA, MAA, IND, CTA
- Change Control system: design and management
- Data integrity: understanding and systemic prevention
- IRCA certified auditor
Biorkys Yáñez Chamizo
Head of GMP Inspectorate, CECMED, Cuba
With more than 20 years of experience in pharmaceutical legislation and its verification through GMP inspections, the Bachelor on Pharmaceutical Sciences and Master in Technology and Control of Medicines has carried out more than 370 local and international inspections. Currently Biorkys is the Head of the Inspectorate Section of the Center for the State Control of Medicines, Equipment and Medical Devices, the National Regulatory Authority of Cuba.
Since 2003 she has participated, as a temporary advisor, in activities organized and developed by the World Health Organization (WHO) and the Pan American Health Organization (PAHO). She has been part of the evaluation teams of the National Regulatory Authorities of Thailand, Chile, Colombia, Mexico, Canada, Argentina and Peru. She has also collaborated in the actions promoted to strengthen the regulatory capacity of other countries, either through observed audits or in workshops on Good Manufacturing Practices applying the principles of risk management, facilitating a total of seven to date. Biorkys was a member of the group of authors responsible for reviewing and updating recommendations on Good Manufacturing Practices for biological products, which were published in the WHO Technical Report Series 996 and 999, Expert Committees on Specifications for Pharmaceutical Preparations, and in Biological Standardization, respectively.
Member of the Cuban Societies of Pharmacology and Pharmaceutical Sciences; in the latter, she is the secretary of the Regulatory Affairs and Clinical Trials Section.
Quality Director/ Qualified person JSC Valenta Pharm
Graduated as an analytical chemistry specialist,
chemistry department at the Voronezh State University in 2000.
More than 18 years’ experience in pharmaceutical production.
Good command of English.
She started her career as a chemist in quality control laboratory of JSC Veropharm in Voronezh (of injectable medicines and plasters).
In 2003 she was appointed as a head of QC department in the company and was responsible for:
– analytical, microbiology laboratories
– in-process control group include in-process laboratories
2011 – 2014 Head of the quality service in JSC KRKA-RUS company. Created and managed Quality Control Departament, Quality Assurance Departament. She was responsible for pharmaceutical quality system; took part in production and laboratory facilities building activities.
Head of Quality department and Authorized person in JSC Valenta Pharm since 2007.
As a state representative person in pharmaceutical quality system Anna is responsible for the Pharmaceutical system efficiency and she has a Qualified person at the Valenta Pharm.
Director for legal and corporate Affairs of the Eurasian division of Bosnalek JSC»
Graduated from Voronezh State University, majoring in jurisprudence, and Financial University under the Government of the Russian Federation, specializing in taxes and taxation.
Has 16 years of experience in the pharmaceutical industry in Russia.
Prior to 2005, he headed the legal department of the PROTEK group of companies.
In the period from 2005 to 2012 he held the position of Director of the Legal Department in the Pharmacy chain «RIGLA».
From 2012 to 2015, he headed the Legal Department in the A5 group of companies.
Since 2016 and up to the present time he heads the Legal and Corporate Affairs Department of the Business-unit Eurasia of JSC Bosnalijek.
Member of the Board (Minister) for Technical Regulation of the Eurasian Economic Commission (EEC)
In 1975 graduated from the Minsk Higher Air Defense Anti-Aircraft Missile School.
In 1991, completed a course for quality system experts in England. Ph.D. in Engineering Science, Associate Professor.
1992 – 2006 Chairman of the Standardization, Metrology and Certification Committee under the Byelorussian Council of Ministers.
2006 – 2011 Chairman of the Byelorussian State Standardization Committee.
Since 1997 – Deputy Chairman of the Working Group for Standardization of the United Nations Economic Commission for Europe.
For a decade he was Head of the Interstate Council for Standardization, Metrology and Certification of the Commonwealth of Independence States (CIS).
As of February 1, 2012: Member of the Board (Minister) for Technical Regulation of the Eurasian Economic Commission.
Head of Division for Coordination of Common Market for Drugs and Medical Devices Formation, Technical Regulation and Accreditation Department, the Eurasian Economic Commission (EEC) “Approaches and methods for studying the medicines stability in the EAEU law”
- 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.
Deputy Chairman of the pharmacy Committee of the Ministry of health of the Republic of Kazakhstan
Asylbekov Nurlybek Abibullaevich – Deputy Chairman of the Pharmacy Committee of the Ministry of Health of the Republic of Kazakhstan.
Labor activity began as a pharmacist – a technologist, deputy director of the regional production site «Pharmacy».
Since 2002 to the present moment he works in the Committee of Pharmacy, supervised the territorial departments in several regions of Kazakhstan. From 2012 to 2015 he worked as the Chief Inspector of the Office of the Prime Minister of the Republic of Kazakhstan.
He studied on the implementation of international standards GxP at the training centers in the US, Denmark, etc. He was one of the first inspectors who conducted an independent inspection on compliance with the national GMP rules.
Participates in the development of regulatory legal acts in the sphere of circulation of medicines of the Republic of Kazakhstan.
Married, has 4 children.
Head of Department on Drug Product Inspection and Expert Evaluation, State Institute of Drugs and Good Practices
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.
Head of the Department for Industrial Pharmacy, I.M. Sechenov First Moscow State Medical University, Member of the Council for professional qualifications in pharmacy
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.
Pharmacist, PhD in / Candidate of Pharmaceutical Sciences
- In 1985 graduated from the First Moscow State Medical University.
- In 2006 graduated from the International Business Quality Institute and passed the voluntary certification for the GOST R system, having obtained the qualification of an expert in quality management systems.
- Started working in the pharmaceutical industry since 1985 as the head of the control and audit department of the Main Pharmacy Administration, then has been a part of various pharmacy institutions and wholesale pharmaceutical organizations.
- From 2006 to 2009 – Executive Manager of the Russian Association of Pharmacy Chains (RAAS).
- From 2009 to present time – Executive Manager of the Non-Commercial Partnership to Promote the Development of the Pharmacy Industry «Pharmacy Guild»
- From 2014 to present time – Executive Manager of the «National Pharmaceutical Chamber».
Is an expert of the medicine section of the Government Expert Council (Open Government), a member of the Committee for self-regulation of entrepreneurship of the Chamber of Commerce and Industry of the Russian Federation, the Executive Secretary of the Council for Professional Qualifications in the field of pharmacy and an expert of the working group on formation of councils for professional qualifications of the National Council for Professional Qualifications under the President of the Russian Federation.
In addition, works in government advisory bodies and working groups: an expert on assessment of the regulatory impact of orders of the Ministry of Health under the Department of Regulatory Impact Assessment of the Ministry of Economic Development of Russian Federation, an independent expert on draft guidance for industry documents of the Ministry of Health of the Russian Federation.
Senior Director Regulatory Affairs & Healthcare Policy, Association of International Pharmaceutical Manufactures (AIPM), Moscow, Russia
Elena Popova is heading the position of Senior Director Regulatory Affairs and Healthcare Policy in Association of International Pharmaceutical Manufacturers (AIPM), Russia.
Elena works more than 15 years in international pharmaceutical industry in areas of new products development, regulatory affairs, quality control and pharmacovigilance. Before to join AIPM, Elena took position of Head New products & Business development in international pharmaceutical company.
She is graduated from Russian State Medical University, holds PhD decree in medicine and MBA degree in Strategic management from the University of Antwerp, Belgium.
Elena in her role in AIPM is responsible for the leading and coordinating association activities related to the range of regulatory policy and technical standards, supporting the harmonization of the requirements for the medicinal products registration and regulatory convergence.
B. Pharm, PhD, AstraZeneca Pharmaceuticals
Prof. Stott is currently Vice President, Global Product Development at AstraZeneca. Leading a group of over 350 scientists and engineers in the development of all products, manufacturing processes and analytical methods for the AZ small molecule portfolio. Specialist technologies include oral solid dosage forms, parenteral products and delivery devices and drug delivery / targeting.
Global Product Development has centres in the UK, Sweden, US and China and a network of partnerships with colleagues all over the world. Recent products that have been registered globally under his stewardship include: Brilinta, Seroquel XR, Caprelsa, Zinforo, AvyCaz, Bydureon BCise, Lynparza, Tagrisso, Calquence and Lokelma.
In addition, Paul is a visiting Professor of Pharmaceutics at the University of Manchester, UK and founder of the North West Centre for Drug Delivery (NoWCADD) at the University.
He is a proven senior manager and strategic leader in Pharmaceutical Development with experience across geographical boundaries. Passionate about the development of individual and group capabilities and the application of innovation and scientific rigour to bring new medicinal products to market.
He is recognised within the Industry and with Regulatory Agencies as a driving force in the establishment and realisation of best practice in CMC Quality by Design. With a history of driving successful partnerships across industry, academia and government organisations across the globe.
Director Regulatory Affairs (European Federation of Pharmaceutical Industries and Associations)
Pär Tellner is Director, Regulatory, Drug Development and Manufacturing at EFPIA since 2012. He is also in charge of the EFPIA support to the international regulatory affairs and member of the ICH Management Committee and Assembly.
Pär has previously been working as Compliance officer (marketing ethics) and Director of Veterinary Medicine, LIF Sweden and as Head of regulatory affairs for several pharmaceutical companies, e.g. Octapharma, Biovitrum, Pharmacia Plasma Products and Novartis. Pär has also been working as Senior Pharmaceutical Officer for the Swedish Medical Products Agency.
Pär graduated as a pharmacist at Uppsala University in 1986.
Regional Manager, Regulatory Affairs, EFPIA
Current position: Regulatory Policy Lead Eastern Europe, Middle East & Africa.
Susanne holds a M.Sci. in Analytical Chemistry from the Humboldt. University in Berlin, Germany and a PhD in Biophysical Chemistry from the Biozentrum of the University of Basel, Switzerland.
She has more than 17 years of experience in technical regulatory affairs. After working in a small biotech company in the US Susanne joined Roche in 2001. There she held different positions with increased responsibilities and gained extensive experience with global filings of new drug submissions, clinical trial applications as well as post-approval changes. Knowing the challenges of operating globally she is now a strong advocate for global convergence of regulatory requirements and has been engaged in several workshops/ meetings with regulators from various emerging markets over the last years.
Susanne is a member of the EFPIA International regulatory expert group, chair of the EFPIA Russia regulatory network, member of the Middle East network and IFPMA Africa regulatory network.
General Manager of «SojuzParma-TM» Ltd, member of the Council of the Union «National Pharmaceutical Chamber», member of the Council for Professional Qualifications in the field of pharmacy
- Moscow State Aviation Technological University
- MBA in Health Care (Institute of Continuing Professional Development of the First Moscow State Medical University)
- Started working in the pharmaceutical industry in 2005 as the head of the regional development branch of the Association of Pharmacy Institutions «SojuzPharma»
- 2010 to present – General Manager of «SojuzParma-TM» Ltd
Deputy Executive Manager of the Association of Pharmacy Institutions «SojuzPharma».
Deputy Chairman of the commission on the circulation of medicines of the Non-Profit Partnership «OPORA» – an expert consultative body designed to promote the development of small and medium-sized businesses in the pharmaceutical industry;
- Member of the Council of the Union of Pharmaceutical Workers for Promoting the Development of the Profession and Pharmaceutical Industry “National Pharmaceutical Chamber” (NFP); Member of the Council for Professional Qualifications in the field of pharmacy of the NFP.
Involved in the development of the system of continuous medical and pharmaceutical education.
Director of the Department for Market Launch & External Communications, and Vaccines Unit of MSD
Heads the Department for Market Launch & External Communications at MSD Russia since December 2015. Is responsible for the strategy of introduction of company’s drugs and vaccines to the Russian market, pricing, relations with government agencies and non-profit organizations. As of January 2018, in charge of strategic development of the company’s Vaccine Unit.
From 2013 to 2015, worked as GR Director at AbbVie in Russia and CIS countries.
Previously held senior positions in external relations at Novartis Group and General Electric (GE).
Graduate of the Moscow State Institute of International Relations (MGIMO): Bachelor’s degree in Political Science, Master of International Business and Business Administration.
Head of International Regulatory Department, Life Science Division at «Merck»
Mr. Sehat holds a doctorate in chemistry and certification from the German state Council in food chemistry. He has lived in three parts of the world (Europe, North America and Asia) and appreciates this experience.
Najib Sehat is the Head of the global regulatory Authority for the life Sciences of Merck. In this position, he is responsible for regulatory activities in the world for a diverse portfolio of products in the field of Biomedical Sciences and the entire life cycle management. These activities include the registration and licensing of the product, the permission for import and export and related registration sites, and the development of strategies and concepts for the registration of the aforementioned products. His position requires active monitoring of the ever-changing global regulatory landscape and expertise to meet new or changing regulatory rules.
Mr. Sehat joined Merck in 1999 and has almost 20 years of experience in the field of regulation, quality and maintenance in Merck. His experience includes knowledge of regulatory and quality requirements across a diverse portfolio of Biomedical science products. Prior to joining Merck, Najib Sehat had 5 years of experience with the US FDA in Washington, D.C., and 3 years of experience with the University of Hamburg and the Institute of hygiene in Hamburg, Germany.
Miguel Ángel Sancho Alpañés
GMP inspector, Spanish Agency of Medicines and Medical Devices
- January 2010–July 2010 Pharmacist, FREMAP clinica (Spain). Custom dispensing medications, stock management, compounding and specialized pharmaceutical care.
- July 2012–May 2014 Deputy Pharmacist Farmacia Serrano (Spain). Custom dispensing medications, stock management, compounding and specialized pharmaceutical care.
- April 2015–Present Official – Pharmaceutical inspector, Agencia Española de Medicamentos y Productos Sanitarios (Spain). GMP/GDP inspector.
- September 2005–January 2011 Degree in Pharmacy – Industrial Speciality.
- Universidad Complutense de Madrid (Spain).
- Expertise GMP/GDP Inspection. Laboratory and Pharmaceutical Industry Procedures. Pharmaceutical care.
- Memberships Registered with the Colegio Oficial de Farmacéuticos de Madrid. (COFM).
GMP Inspector – National Institute of Pharmacy and Nutrition, Hungary
- Febr 2015 – Present: GMP Inspector – APIs, non sterile and sterile medicinal products National Institute of Pharmacy and Nutrition, Hungary
- Nov 2009 – Febr 2015: QA Manager – Quality Compliance Teva Pharmaceutical Ltd., Hungary
- Mar 2005 – Nov 2009: QC Manager – Solid Dosage Laboratories Teva Pharmaceutical Ltd., Hungary
- May 2004 – Mar 2005: QC Manager – Sterile Products Teva Pharmaceutical Ltd., Hungary
- Aug 1998 – Apr 2002: QC Manager – Sterile Products Teva Pharmaceutical Ltd., Hungary
- May 1996 – Aug 1998: Analyst – Quality Control Teva Pharmaceutical Ltd., Hungary
Eötvös Lóránd University, Budapest – Chemist (MSc), Pharmaceutical Research & Development
Director of Regulatory Affairs University of Washington (USA)
Dr Drago received a doctorate in chemistry from the Swiss Federal Institute of technology (ETH, Zurich).
Dr. Daniela Drago is associate Professor and Director of regulatory programs at the Institute of medicine and medical Sciences at George Washington University. Before joining academia, she worked in the pharmaceutical and medical industries. She has held leadership positions in global regulatory and medical activities at F. Hoffman-La Roche, Vifor Pharma, Reckit Benckiser and Bausch and Lomb.
Its work is cross-functional in politics, education and innovation. Her current research interests are aimed at optimizing health care development and promoting regulatory science. She is a full-time lecturer and has published many articles. Dr. Drago works on the Board of Directors of the Association of teachers of higher education (AGRE). She is a co-chair of the Standing Committee on regulatory Affairs (RAPS), Washington office, and an expert consultant on regulatory issues of the Organization for regulatory professionals (TOPRA).
Director of product in the company «PHARMA TRADE»
Dmitry Bagley was born and raised in Rostov-on-don. He graduated from secondary school №69 and entered the mechanics and mathematics faculty of Rostov state University in 1999 with a silver medal. He entered the graduate school of the North Caucasus Scientific Center of the Higher School after graduating from the University in 2004.
He graduated from graduate school and defended his thesis on «HR risk management in the sphere of business economic security at the Department of Economics» at the southern Federal University in 2007. He has several publications in publications and journals.
He has lived and worked in Moscow since 2007. He has experience in public and commercial medical organizations, as well as consulting companies that provide services for the automation of medical and pharmaceutical institutions.
Participated as an engaged expert of the Department of information technology and communications of the Ministry of Health of Russia in the preparation of project materials, which were included in the approved Order of the Ministry of health of Russia № 866 from 30.11.2015 year 2015 year in the framework of the project on the labeling of drugs for medical use.
He worked in JSC «Centrinform» since July 2016, and later in LLC «Center for the development of advanced technologies» as a business analyst on the project of labeling of drugs. Participated in the preparation of guidelines for the Experiment and Passports of business processes (published on the website of the Federal Tax Service in the section «for developers of information systems») for the period of cooperation with Roszdravnadzor and the Federal tax service of Russia.
He is the Director of product «Check, Track & Trace» in the company «Pharma Trace» since June 2018, providing pharmaceutical companies with consulting and information services on connection and interaction with the Federal State Information system for monitoring the movement of drugs.
Director Quality External Affairs Amgen (Europe) GmbH
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.
Executive Director for Global External Development «MSD»
Ganapathy Mohan leads the Global External Advocacy for Global Quality in Merck Manufacturing Division. Prior to this until April 2017, he was the head of Small Molecule Development Quality, which is responsible for ensuring GMP compliance and release of all materials and investigational Medicinal Products for use in clinical trials.
Mohan was the head of Global CMC regulatory Affairs at Merck until April 2015.
Prior to joining Merck he was Associate VP of Global Analytical Sciences at Sanofi and was there for 23 years.
Mohan has a Ph.D in Analytical Chemistry from Kansas State University and his area of interests are in separation sciences, application of PAT and science driven risk based approaches towards global registrations of pharmaceuticals and biologics.
Mohan was past Chair of the AAPS Regulatory Sciences Section in 2014 and has served in the Council of experts for the United States Pharmacopeia till 2015. He currently represents Merck in the PhRMA GQMWG and serves as the member of the Quality Coordinating Committee of IQ Consortium.
Álvaro Israel Pérez Vega
Commissioner of Sanitary Enforcement, COFEPRIS
Lawyer with specialization in Administration and Public Finances by the Metropolitan Autonomous University (UAM); He studied postgraduate diploma courses on Tax Law in the Autonomous Institute of Technology of Mexico (ITAM) and in Financial and Fiscal Crimes in the National Institute of Criminal Sciences (INACIPE), he has participated in the Update Course on The Federal Law of Administrative Procedure and Update Course in Legal Protection Matters by the National Autonomous University of Mexico (UNAM), taught the Modules «Sanitary Regulation» and «Advertising» in the Diploma Course in Pharmaceutical Marketing at the Anahuac University.
With an outstanding participation in highly relevant events in national and international delegations such as: Representation of Institute of Security and Social Services of State Workers (ISSSTE) in the Ninth International Conference on Information Technologies in Social Security in Montreal, Canada; for the Supreme Court of Justice of the Nation and National Academy of Medicine, Analysis of Practical Cases: Health Security Measures as Lawyer Speaker; Seminar Implications of Law in Medicine, Supreme Court of Justice of the Nation and National Academy of Medicine, Analysis of Practical Cases: Health Advertising as a Lawyer Speaker; 9th International Conference Molluscan Shellfish Safety (ICMSS); Representative of COFEPRIS in several international events around the world as for the World Health Organization, regarding food safety, medicines, medical devices, tobacco control, narcotics, among others.
He held the positions of Deputy Director General of Customs Law and Foreign Trade and Director of Negotiation of Treaties and Special Projects at the Ministry of Finance and Public Credit; Legal Manager at Financiera Rural; Head of Fiscal Affairs Services at ISSSTE, as well as various positions in the Federal Public Administration.
He was General Legal Director of the Federal Commission for the Protection from Sanitary Risks (COFEPRIS). He is currently Commissioner of Sanitary Enforcement.
Head of the Astana Office for the Development of Good Pharmaceutical Practices and Global Quality at the Kazakhstan National Center for Evaluation of Medicines, Medical Devices and Equipment
MSc in Pharmacy
Candidate of Pharmaceutical Sciences
Government Award for Meritorious Accomplishments in Public Health.
Elena started her career as Professor of the Pharmacy Department at the Almaty Institute for Advanced Medical Training. Later she headed the Department of the Medical Technologies Evaluation at the Kazakhstan Institute of Public Health. There she implemented a scientific and technical program dedicated to the introduction of medical technologies evaluation and pharmacoeconomic research in Kazakhstan.
Several years she headed the chair of Management in Public Health and Pharmacy at the Kazakhstan Higher School of Public Health (for advanced training, retraining, postgraduate and doctoral studies).
Currently as a GMP inspector of domestic drug production, she also evaluates production conditions, quality assurance systems of foreign pharmaceutical manufacturers. Continuously upgrades her GxP qualifications.
Member of the PIC/S working group of the Pharmacy Committee of the Kazakhstan Health Ministry.
Represents Kazakhstan in the EAEU working group for harmonization of pharmaceutical inspections procedures.
Author of more than 120 scientific works published domestically and abroad (including impact factor), four methodological recommendations, two teaching aids and three manuals.
EMA representative (European Medicines Agency)
Roberto Conocchia is a Scientific Administrator at the European Medicine Agency (EMA) since March 2018.
- Obtained a Master degree in Bio-Chemistry from the University of Rome «La Sapienza» and a Post-graduate master’s degree in Natural substances and bio-organic Chemistry.
- Worked in three different API manufacturing sites in Italy from 2000 to 2006.
- Worked as GMP inspector at the Italian Agency Medicine (AIFA) performing regulatory inspections of pharmaceutical manufacturers (all dosage forms), focusing on sterile, not sterile and biological products from 2007 to 2012.
- Worked at the European Medicine Agency (EMA) as National Expert from 2012 to 2013 coordinating GMP inspections.
- Worked as GMP Senior inspector at the Italian Agency Medicine (AIFA) from 2013 to February 2018.
The head of the Inspectorate HALMED (Croatia)
Head of Croatian Inspectorate responsible for GMP/GDP and Pharmacovigilance inspections. Pharmaceutical GMP/GDP/GVP/GCP regulatory management professional with experience from both pharmaceutical industry and regulatory.
Before joining Croatian regulatory body worked several years in industry on different position: quality assurance / compliance management, quality control management, validations / qualifications, inspections/audits.
Active in international cooperation in the area of Good Manufacturing/Distribution Practice (GMP/GDP) and Good Pharmacovigilance Practice (GVP) – PIC/S, FDA-EU MRA, Health Canada-MRA, TGA-MRA, Japan-MRA, EDQM, JAP, Rapid Alerts. BEMA assessor, HALMED delegate in HMA, Working Group of Enforcment Officers and Inspectors Working Group. Internal auditor. European Commission TAIEX expert for pharmaceutical field. Lecturer at pharmaceutical conferences and University of Zagreb. Executive board member in working group «Industrial Pharmacy» at Croatian Pharmaceutical Society.
Senior Director for Manufacturing/Quality and Compliance Pharmaceuticals and Medical Devices Agency (PMDA), Japan
- 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.
Martin Koprivnikar Krajnc
A fifth year student at Faculty of Pharmacy at University of Ljubljana in Slovenia
A fifth year student at Faculty of Pharmacy at University of Ljubljana in Slovenia and also a member of International Pharmaceutical Students’ Federation (IPSF). Has been active in IPSF since the second year of the studies.
First he was in charge of student exchange on national level and of organisation of Interntational Pharmaceutical Summer Camp with participants from all over Europe. After that he was in charge of Student Exchange Programme on international level with around 1000 participants every year.
In 2017 he was logistics officer for Annual Congress of European Pharmaceutical Students’ Association with around 450 participants.
This year he was doing an internship in Community pharmacy Prule-Trnovo. Currently he is working on his master thesis and Corporate Relations Coordinator and representative for International Pharmaceutical Students’ Federation, representing 350 000 students and future pharmacists all around the globe.
«Chemgineering», член наблюдательного совета отделения ISPE DACH
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.
Ziv Dee Noor
Head of Life Science – Baran Group
1993 BSc in Chemical Engineering, Technion – Israel Institute of Technology.
2008 MBA – Haifa University, Israel.
For 17 years he was with TEVA Pharmaceuticals in various positions of manufacturing, research and development, engineering and management. For 8 years he was leading the API process engineering overseeing 18 production sites worldwide.
His main areas of expertise are: process scale-up, technology transfer, process validation and production plant design.
During his years with TEVA he was leading the design of more than 12 API plants employing wide range of technologies: classic synthetic chemistry, fermentation, peptides, plant extracts and high potent materials.
Lately, Ziv has joined Baran Group to lead the Pharma, Biotechnology, and API activities.
Executive Director of the Bulgarian Drug Agency
Deputy Executive Director of the Bulgarian Drug Agency since November 2017.
Master degree in Pharmacy from Faculty of Pharmacy, Medical University, Sofia. Master degree in Public Health from Faculty of Public Health Medical University, Sofia.
PhD candidate in Medical University, Varna. Eight years’ experience in Pharmaceutical industry in different positions.
Vice President for Quality and Compliance, NovoNordisk, formerly FDA Policy and Regulation Deputy Director (USA)
Dr. Andrew Chang has more than twenty years of experience in the development, regulation and quality of biologics and pharmaceuticals. At his current capacity as a Vice President, Quality and Regulatory Compliance, Quality Intelligence and Inspection, Novo Nordisk A/S, he is responsible for external affairs, providing strategic advice and solutions for quality and regulatory related issues, and expert support to inspection preparation.
Since 2013, Andrew has represented Novo Nordisk at several work groups in industry trade organizations, e.g., PhRMA, BIO to advocate patient and industry’s interests by developing position papers and participating liaison meetings with the regulatory authorities. He is also a member of PhRMA and BIO’s ICH Work Groups, and representing PhRMA as an expert to ICH Q12 Expert Working Group for developing guideline on Pharmaceutical Products Lifecycle Management.
Prior to Novo Nordisk, Andrew served more than eleven years at US FDA, most recently as an Associate Director for Policy and Regulation, Acting Deputy Director and Senior Regulatory Scientist in the Division of Hematology, Center for Biologics Evaluation and Research (CBER).
During his tenure, Andrew received numerus high level FDA awards for his exceptional and outstanding performance on regulatory review and management, GMP inspection, and policy development. These include, but are not limited to FDA Commissioner’s Special Citation for successfully completing FDA’s initiative on product quality regulation and CBER’s Public Health Achievement Award for outstanding regulatory review performance that resulted in averting a crisis in product availability. In 2002, the FDA recognized Andrew as the FDA regulatory expert in the regulation of new and novel recombinant products as well as naturally-derived biological products.
Andrew’s formal scientific training includes post-doctor in immunology from the National Institutes of Health, Ph.D. in Biochemistry from the State University of New York, and B.S. in Pharmaceutical Chemistry from the China Pharmaceutical University. He has published numerus peer reviewed scientific papers in JAMA, J.Exp.Med., Blood, J.Immunol., Dev. Immunol. Thromb Haemost., Haemophilia, Pharmaceutical Engineering etc., and has been a frequent speaker at national and international conferences.
Head of the Department for Good Engineering Practice of the State Institute of Drugs and Good Practices
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.
The head of the food direction "Pharma" of the Center for Advanced Technology Development
2007-2009 – Head of Key Accounts, Microsoft Rus.
2010-2011 – Commercial Director of Federal State Unitary Enterprise “Federal Cadastre Center” Earth “.
2012-2015 – management of the project management office, project portfolio management of the Higher School of Economics.
2015-2017 – Head of Competence Center, PJSC Gazprom Automation.
Head of Engineering & Technology Department within Bayer JSC
Engineering & Technology Department is involved in the research, technological, production and investment projects of the Bayer Group.
In particular, in Russia and the CIS, Engineering & Technology Department participates in the preparation and implementation of investment projects related to the creation of new and reconstruction of existing production facilities, as well as the organization of production of Bayer products on contract manufacturing sites.
At present, the Bayer Group produces in Russia crop protection products, medicinal and veterinary preparations. Engineering & Technology Department also ensures readiness of production lines and IT infrastructure for the implementation of Russian Track & Trace system.
Prior to Bayer, Evgeniy worked in Russia and Europe in major international companies, including DuPont and Honeywell.
Abbott Quality Assurance Director
Dr. Ulrich Becht is a pharmacist and started in the pharmaceutical industry in 1985 at Knoll AG, Germany.
He has held several managerial positions in QC and QA and acted as a Qualified Person.
At Abbott GmbH he was Head of Quality at Ludwigshafen site for more than 10 years.
Since 2010 he has held positions in the global QA organization of the Pharma Division of Abbott incl Regional QA Director Asia Pacific.
Chief editor of the information and analytical newspaper «Pharmaceutical Bulletin»
German Inozemtsev is one of the recognized experts in the field of pharmaceutical and medical markets of Russia and CIS, having experience in key management positions in the retail and manufacturing sectors of the pharmaceutical and medical industry, as well as in government agencies (Department of Health of the Government of Moscow). He has diplomas in management and marketing: Cambridge Marketing College (UK) and Chartered Institute of Marketing (London, UK). From 1999 to 2002 he studied and worked in Sydney where he was awarded an MBA from Australian Business School.
In October 2005 he successfully published his monograph in the field of pharmaceutical marketing: «Marketing thinking – Product planning». Since January 2007 he has been conducting master classes at the State University – higher School of Economics and school of Pharmaceutical Marketing. He is the author of several professional books.
Regularly takes an active part in major international business forums, is a co-Chairman of the coordinating Council RAPM (Russian Association of Pharmaceutical Marketing) and AAMM (Association of pharmaceutical Management and Marketing). Organizes, conducts and speaks at the meetings of the Association, which aims to exchange professional knowledge and experience, as well as to consolidate the views and actions of the entire professional medical and pharmaceutical community of manufacturers, distributors, representatives of pharmacy retail and analytical companies aimed at the further development of quality and socially-oriented health care in the Russian Federation.
It was under his leadership that the Russian company pharmacy chain 36.6 began to produce products under its own brand, and the domestic production company Veropharm changed its marketing strategy and significantly updated the portfolio of medicines.
He has relevant management experience in leading companies: Synovate Comcon Healthcare as Director of strategy, pharmacy Network 36.6 as Director of its own Brand, Veropharm as Director of Marketing, Pasteur Merieux Connaught (Sanofi) as Director of Sales, SmithKline Beecham (GSK) as product Manager and marketing Director Centrelink (Sydney, Australia).
His professional experience includes both work at the headquarters of pharmaceutical companies in London and Philadelphia, and consulting work in the field of marketing for leading pharmaceutical companies in Russia, Ukraine and Kazakhstan.
Head of the Eurasian division «Bosnalek»
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.
Executive Director SPFO
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.
Domenico Di Giorgio
Head of Inspectorate, Italian Medicines Agency (AIFA), “Inter-agency cooperation in combatting the pandemic COVID-19”
Former chairman of EDQM/Council of Europe Committees CMED (Counterfeit medicines) and CDPPH (Steering Committee Pharmaceuticals).
Editor of «Counterfeit medicines» (CoE/EDQM Publishing) and other 8 internationally published books on illegal medicines, including the «Volcano Operation White Paper» submitted by AIFA/WGEO to the EC after the international investigation developed and coordinated in 2004-2015.
Italian delegate in the negotiation of Dir. 2011/62/EU and Council of Europe MEDICRIME Convention. Coordinator of the Fakeshare projects, aimed at developing web resources for investigators dealing with pharmaceutical crime at an international level.
Takeda Pharmaceutical International AG
Topic: “Facility Engineering, New Technologies and Automatization”
Josef Trapl, Global Head of Technology within the Global Engineering Organization in Takeda Pharmaceuticals International based in Zürich, Switzerland has long term professional project experience serving the Pharma Industry in Engineering & GMP consulting, designing and building capabilities.
He is a chartered Chemical Engineer (MChE) with extensive global design and pro-ject execution experience across quality and other business areas in the Bio-Pharmaceutical In-dustry covering Bio-API, Fill&Finish and Oral Solid Dosage (OSD) production.
He is with Takeda since 2015 and was parallel acting as regional engineer for Europe/CIS until end of 2016 to sup-port the transformation of the Global Engineering organization and has a Master of Business Administration (MBA) degree from the Mannheim Business School, Germany. In his current cor-porate role as a technology manager he is responsible for industry trends, new technologies and automation (Pharma/Industry 4.0/IoT), technology transfer, operational excellence and to follow regulatory aspects.
Economic Security Director, GEROPHARM
Andrey Akhantyev was born in 1960 in Novosibirsk. He graduated from the Pacific Higher Naval School named after S.O. Makarov in Vladivostok. During his military and state service he held difference executive positions. Andrey Akhantyev has got supplementary education according to retraining programs focused on economic and business at the Far Eastern Federal University.
After his discharge from the state service he worked on economic security in business structures.
Andrey Akhantyev has been working in GEROPHARM group of companies since 2008. He has passed additional training for economic and information security of business, government procurement.
Andrey Akhantyev is an expert and permanent participant of largest thematic conferences, official meetings on the issues of legislative regulation in pharmaceutical industry. He also takes an active part in expert groups work and meetings with regulatory authorities.
Doctor of Pharmaceutical Sciences, Head of the Department of Technology for Drugs and the Organization of Pharmaceutical Affairs of the Faculty for Advanced Training of Medical Professionals of the RUDN University. Director of the Shared Research and Education Center of the RUDN University.
Date of birth: 25.10.1965
Ryazan Medical Institute, pharmaceutical faculty, specialty – pharmacy (1988),
PhD in Pharmaceutical Sciences (1995), Doctor of Pharmaceutical Sciences (2013).
Since 1988 – senior researcher at the Laboratory of Pharmaceutical Technology of the Institute of Pharmacy.
Since 1998 – Head of the Department of pharmaceutical technology, Faculty of Advanced Training of Medical Workers of the RUDN University.
Since 2009 – the director of the Shared Research and Education Center of the RUDN University.
Member of the Pharmacopoeial Committee (since 2013), Member of the Dissertation Councils of the RUDN University (Organization of Pharmaceutical Affairs (Pharmaceutical Sciences); Technology of obtaining medicines (pharmaceutical sciences); Pharmaceutical chemistry, pharmacognosy (pharmaceutical sciences)).
Member of ISPE (International Society for Pharmaceutical Engineering) since 2003. Since 2018 the Director of ISPE EAEU.
Expert of the Institute of the State Pharmacopoeia of the Ministry of Health of the Russian Federation, Certification Expert for Authorized Persons, Member of the Council of Women of the Russian Federation.
Author of 5 patents, more than 100 scientific publications.
Executive director, X-Tech “CM elements for oral solid dosage process”
Dmitry graduated from the Peoples’ Friendship University of Russia, majoring in Jurisprudence. He began his career in OOO NNE FARMAPLAN. For a long time Dmitry worked in companies Notex and Technocom Engineering.
Since 2016, Dmitry is the general director of LLC “X-TECH”. The company specializes in complex solutions in the field of supply and commissioning of equipment for the pharmaceutical, biotechnological, chemical, cosmetic and food industries. For more than 10 years Dmitry has been successfully working in the market of supplies of equipment for complex solutions for the pharmaceutical, food and chemical industries.
Vice President of Optel Group
Louis earned an Engineering degree and an MBA from Université Laval in Québec City, Canada, before joining OPTEL GROUP, the leading global provider of traceability solutions.
Over a period of five years, he held a variety of positions, notably in Operations and Research Development, while the company was experiencing 100% growth. Having gained considerable experience in Track & Trace solutions for the worldwide pharmaceutical industry, he was appointed VP Global Pharmaceutical in January 2018.
Director, Quality and training department FAVEA Group
Expert in GMP issues
Zdeněk Pavelek graduated from the Masaryk University in Brno (Czech Republic), Faculty of Science.
Prior to joining FAVEA Group, Zdeněk worked as a the Quality Management Director in the company “TEVA Czech Industries”, where he supervised the preparation of a quality system for FDA inspections, which were successfully completed in 2010, 2011 and 2014.
Prior to that, he held the posts of the head of the quality control department and the director for quality assurance at company “Galena”.
During his work Zdeněk Pavelek has developed a number of author’s training courses and lectures for the training of specialists of pharmaceutical companies in the Czech Republic and other European countries: Slovakia, Poland, Latvia, Lithuania, Germany, Switzerland, as well as Ukraine, Russia, Kazakhstan, China and Brazil.
Zdenek also has a wide experience in validation and qualification issues, technology transfer and other issues related to the organization and operation of pharmaceutical production.
At the moment he actively participates in the preparation of pharmaceutical producers of medicines for official audits and audits by EU and US regulators, training of personnel, and also operates the Quality management of FAVEA Group projects.
Head of the BWT pharmaceutical projects in Russia
Moscow State academy of food productions, engineer-biotechnologist; Moscow international higher school of business “MIRBIS”, economist; MBA in “Production management”.
Clean media systems, solution preparation stations, technological gases.
24 years on pharmaceutical market, including production and engineering. Since 2005 in BWT.
Mr. Movsesov has realizes big projects of clean media systems, including systems for local productions of market leaders: NovoNordisk, Novartis, AstraZeneca, Teva, Takeda Nycomed, Gedeon Richter, etc.
The coauthor of MU 78-113 “Preparation, storage and distribution of the water purified and waters for injections”, 1998.
Author of thematic articles.
Quality Director, Akrikhin “Remote inspections: experience and results”
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.
Federal state budgetary institution “Russian medical scientific and production center “Rosplasma” of Federal Medical-Biological Agency of Russian Federation Advisor to the Director General.
I graduated from the Ural Polytechnic Institute, faculty of chemical technology.
Since 1993, my work has been related to ensuring the quality and safety of blood and blood components. I worked at the Blood Centre; at the Federal Service for Surveillance in Healthcare; at the Federal Medical-Biological Agency of Russian Federation.
Now I am member of the ad hoc working group (GTS) on the «Guide to the preparation, use and quality assurance of blood components» of the Council of Europe (EDQM)
Publication of the 16th; 17th and 18th editions of the Guide in Russian language is organized.
I participated in the development of legal and regulatory documentation in the field of blood donation and quality assurance of blood and components.
I translated into Russian language WHO course materials “Quality Management in Blood Transfusion Service” and conducting training courses in Russia, CIS and Eastern Europe.
I have 19th published articles on quality and standardization in the Blood Transfusion Service in Russian and foreign editions.
GR Director of LLC "X-Tech".
Alexey graduated from I. M. Sechenov Moscow Medical Academy the Moscow Medical Academy.
Author of numerous publications in the editions of Science and Life, Kommersant, Vedomosti, Russkaya Gazeta, and others.
Member of the Council of the Leaders Club.
Member of the Expert Council of the Working Group “Business Projects” of Strategic Initiatives Agency.
Member of the Commission on Pharmaceutical and Medical Industry of the Russian Union of Industrialists and Entrepreneurs.
Alexey participated in a variety of business events, such as, Petersburg International Economic Forum, GMP Summit, Life Sciences Invest forum and others.
Mrs. Elena Zelinskaya
GMP expert Ion Beam Applications Limited Liability Company (IBA LLC)
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
Leading Expert in the Department for Inspection of Medicines and Expertise of the State Institute of Drugs and Good Practices.
Graduated from the Mendeleev University of Chemical Technology of Russia; majored in Chemical Engineering.
In 2010 he embarked on a professional career as a Technology Engineer at the ‘Medradiopreparat’ (Nuclear Medicine Therapies Plant) of the Federal Medical and Biological Agency.
In 2017 joined the Department for Inspection of Medicines and Expertise of the State Institute of Drugs and good Practices in the position of an Expert.
C.E.O. & Founder – PQE Group
Founder and CEO of PQE, Gilda D’Incerti graduated with a degree in Economic Statistics from the University of Bocconi in Milan, Italy.
Gilda has worked extensively in the field of Information Technology and specifically, IT Compliance on both a national and international level for companies such as Siemens Data (Milan) and Edicon (Montreal).Before founding PQE in 1998, Gilda was the IT Manager for The Menarini Group’s Spanish affiliate in Barcelona, following this, Gilda became the Operations Manager for F&J Systems Italy and ultimately an Executive Consultant in Validation for M.I.S.
She is globally recognized as an international expert in the field of Computer System Validation and Data Integrity Assurance due to her broad spectrum of project experience.
Certified Tick-IT and PDA Auditor, Gilda is nowadays a worldwide recognized Expert on Data Integrity providing war room support and strategic consultancy for clients in order to comply with the FDA and other regulatory bodies during critical inspections. Most recently, Gilda collaborated with COFEPRIS in Mexico and ANVISA in Brazil to set up Data Integrity rules and guidance. Gilda has trained on Data Integrity inspectors coming from several regulatory agencies.
Operations Director Europe & CIS Region – PQE Group
Roberto Bertini has more than 20 years’ experience long career in Computerised Systems Validation and Data Integrity assurance. He graduated in Physics at the University of “La Sapienza” in Rome, and he joined PQE in 2000.
He is currently Operations Director at PQE for Europe and CIS Regions, where he is leading the service delivery related to the Business Lines for Data Integrity Assurance.
He has managed the validation process of most common Computerised Systems used in the Life Science environment (e.g. ERP, MES, LIMS, WMS, Lab Systems, PCS, Serialization domain) and he has supported the implementation of Quality Management Systems for the IT governance. He is now supporting a number of pharmaceutical companies in the establishment of Data Integrity Governance and in the resulting Data Integrity Assessment and Remediations.
Strategic Planning and Program Management Office – Global Quality
He has several years’ experience in transformational programs in Manufacturing and Quality in the Pharma and Vaccines sector, in addition to his 15 years of experience in IT development, training and consulting.
Anton Willi is a Computer Scientist & received his degree from the University Newcastle Upon Tyne, England. He has over 15 years of experience in Pharmaceutical Industry at Novartis and GSK with increasing responsibilities in the fields of Computer Systems Validation, Quality Management Systems, Training and Program Management. From 2012 he has been responsible for Data Integrity in developing and managing Data integrity improvement programs for Novartis Vaccines and GSK Vaccines. Involved in several Health Authority inspections focused on Computer systems and Data Integrity. In his current role with Novartis his responsibilities include managing the Group Quality Data Integrity Program across all functions and Alcon.
Quality Director, R-Pharm Group “Main provisions of the new version of Annex draft No. 16 GMP EAEU from the perspective of the GMP requirements and the Qualified person job in pharmaceutical enterprise”
Quality director, Geropharm
Executive Director, Union of Professional Pharmaceutical Organizations (SPFO)
Director for Economic Security, Geropharm
Президент компании «Активный компонент» «Пути преодоления зависимости отечественного фармрынка от поставок сырья из Юго-Восточной Азии»
President, Active Component JSC
- Petersburg State University, Faculty of History.
- Petersburg State University, postgraduate studies at the Faculty of International Relations.
- Open University of Great Britain, School of Business, faculty of management.
25 years in pharmaceutics.
- 2015 – present – President, shareholder, pharmaceutical company (API’ development and manufacturing) Active Component JSC.
- 2014-2015 – Vice President, pharmaceutical group of companies ROSTA.
- 2009-2014 – General Director, pharmacy chain ‘First Aid’.
- 2009-2012 – Board of Directors Chairman, pharmaceutical company VERTEX.
- 2006-2011 – General Director, pharmaceutical company Active Component.
- 2001-2006 – General Director, pharmaceutical company VERTEX.
Married, 4 children
Head of Department on Drug Product Inspection and Expert Evaluation, Federal State Institution "State Institute of Drugs and Good Practices" of the Ministry of Industry and Trade of the Russian Federation
General Director, GMP news
Deputy Minister of industry and trade of the Russian Federation
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