Всероссийская GMP-конференция | Programme
Programme
Attention! This page presents the draft program of the conference. In the future, the program will be amended.
September 23, first day
8:30–10:00
Participants’ registration
10:00–10:40
Conference opening
Venue: Main hall
Official part:
  • Welcome speech of the Governor of Kaliningrad region Mr. Anton Alikhanov
  • Welcome speech of the First Deputy Minister of Industry and Trade Mr. Sergey Tsyb*
  • Deputy Director for Technical Regulation and Accreditation Department, Eurasian Economic Commission Mr. Dzhanyl Dzhusupova
  • Passing the Conference cup to the Governor of Kaliningrad region Mr. Anton Alikhanov
Plenary session
10:40–12:15
Contribution of the pharmaceutical industry to the modern development of the state economy
Venue: Main hall
Moderator: Vladislav Shestakov, Director, Federal State Institution State Institute of Drugs and Good Practices of the Ministry of Industry and Trade of the Russian Federation
Issues to be discussed:
  • Inter-agency sector regulation. Open dialogue between government and business
  • Investments in research activities
  • Special conditions for registration of cutting-edge products
  • Generics vs original drugs
  • Investment risks of new manufacturing
  • Developing trade links. Export/Import
  • Public-private partnership
Speakers:
  • Sergey Tsyb*, First Deputy Minister of Industry and Trade of Russia
  • Tatyana Yakovleva*, First Deputy Minister of Health of Russia
  • Aleksander Gutsan*, Russian president’s representative in Northwestern Federal District
  • Anton Alikhanov, Governor of Kaliningrad region
  • Mikhail Murashko*, Head of the Federal Service for Surveillance in Healthcare
  • Rafael Pérez Cristiá, Director General of Cuba’s Center for State Control of Medicines and Medical Devices (CECMED)
  • Gerardo Briceño, Deputy minister of Resources, Technology and Regulation of Venezuela
  • Shingou Sakurai, Senior Director for manufacturing/quality and compliance, Pharmaceuticals and Medical Devices Agency (PMDA) of Japan
  • Grigory Potapov, Chief Executive Officer, Pharmstandard JSC
  • Lars Nielsen, General Director, Roche Moscow
  • Eric Drapé, Executive Vice President, Teva
  • Vladimir Shipkov, Executive Director, Association of International Pharmaceutical Manufacturers (AIPM)
Discussion participants:
  • Dzhanyl Dzhusupova, Deputy Director for Technical Regulation and Accreditation Department, Eurasian Economic Commission
12:15–12:30
Break
Panel discussion
12:30–14:00
Export and priority regions. Regulatory and industry tools
Venue: Main hall
Moderators: Elena Denisova, Deputy director of the Department for pharmaceutical and medical industry development, Ministry of Industry and Trade of Russia and Petr Rodionov, Chief Executive Director, Geropharm
Issues to be discussed:
  • Government-support measures and key indicators for export
  • Prospective export markets and overcoming regulatory barriers
  • Export price – market entry costs, decline in drug prices
  • Experience of Russian and international companies
Speakers:
  • Rafael Pérez Cristiá, Director General of Cuba’s Center for State Control of Medicines and Medical Devices (CECMED)
  • Lesbia Muro, President of National Institute of Hygiene "Rafael Rangel" of Venezuela
  • Shingou Sakurai, Senior Director for manufacturing/quality and compliance, Pharmaceuticals and Medical Devices Agency (PMDA) of Japan
  • Ajmeer Ramkishan, Deputy Drugs Controller of the Central Drugs Standard Control Organization (CDSCO) of India
  • Ferenc Lukács, Inspectorate Head, National Institute of Pharmacy and Nutrition (OGYÉI)
  • Goranka Marušić Kontent, European Affairs Counsellor, Agency for Medicinal Products and Medical Devices of Croatia  (HALMED)
  • Maram Darag, Head of the Manufacturing Site Inspection Directorate, Egyptian Drug Authority (EDA), Ministry of Health and Population (MOHP)
  • Stanislav Uiba, Director, Institute Mechnikov, Nacaragua
Discussion Panelists:
  • Victor Trukhin, Director, St. Petersburg Scientific Research Institute of Vaccines and Serums (SPbSRIVS)
  • Evgeniy Gorokhov, Deputy Director on foreign economic activities , Infamed K
  • Alexey Torgov, Deputy Director for Government Relations, BIOCAD
14:00–15:00
Break
Panel discussion
15:00–17:00
The single market of the EAEU countries: challenges and interaction prospects
Parallel session!
Venue: Main hall
Moderator: Elena Popova, Senior Director Regulatory Affairs & Healthcare Policy, Association of International Pharmaceutical Manufacturers (AIPM)
Issues to be discussed:
  • Legislative harmonization of the member-states and work within the supranational legislation – what has been done and what is next?
  • One year before the end of the transition period – registration status of drugs and inspection of manufacturing in conformity with the EAEU
  • Regulation in the field of drugs circulation within the EAEU – role of the Expert committee. Is the centralized procedure of registration and expertise possible?
  • Practical experience of drug registration and inspection of manufacturing – regulators and industry viewpoint. Key issues and ways of resolving
  • GMP inspections – harmonization of requirements and mutual recognition
  • Single registry of the registered drugs in the EAEU. How should national segments change?
  • Pharmaceutical Inspection Coordination Group. Joint work of the EAEU pharmaceutical inspectorates, first results and perspectives
  • Pharmacopeia of the Union and expertise of module 3 of registration dossier. Quality standards in the EAEU
  • EAEU Good Pharmacovigilance Practice – results of the system’s drugs security monitoring function
  • Training of Qualified Persons of drug manufacturers
Speakers:
  • Dmitry Rozhdestvensky, Head of Division for Coordination of Common Market for Drugs and Medical Devices Formation, Technical Regulation and Accreditation Department, the Eurasian Economic Commission (EEC)
  • Philip Romanov, Director of Department for government control of drug circulation, Ministry of Health of Russian Federation
  • Gelena Grosheva, Head of section for Licensing and Inspections of Drug Manufacturing, Ministry of Industry and Trade of Russia
  • Yuri Olefir, Director, Scientific Centre for Expert Evaluation of Medicinal Products (SCEEMP) of the Ministry of Health of the Russian Federation
  • Mkrtich Shakaryan, Head of Division for Good Pharmacy Practice,  Scientific Center of Drug and Medical Technologies Expertise after academician Emil Gabrielyan, Armenia
  • Svetlana Setkina, Deputy Director, Republican Unitary Enterprise Center for Examinations and Tests in Health Service, Republic of Belarus
  • Nurlybek Asylbekov, Deputy Chairman of the Committee for quality control and safety of products and services of the Ministry of Health of the Republic of Kazakhstan
  • Iskhak Toktonaliev, Leading specialist of Good Pharmacy Practices (GPC) at the Department for Medication Supply, Ministry of Health of the Republic of Kyrgyzstan
  • Sergey Glagolev*, Deputy Head of the Division, Head of the Pharmacovigilance section of the Division for Organization of Quality Control for Medicines, Federal Service for Surveillance in Healthcare
  • Elena Kovaleva, Deputy Director
  • Scientific Centre for Expert Evaluation of Medicinal Products (SCEEMP) of the Ministry of Health of the Russian Federation
  • Natalia Pyatigorskaya, Head of the Department for Industrial Pharmacy, I.M. Sechenov First Moscow State Medical University, Member of the Council for professional qualifications in pharmacy
Discussion Panelists:
  • Madina Sottayeva, Head of Division for International Cooperation of the Pharmaceutical Inspectorates, Head of Department for inspection of medicines and expertise, Federal State Institution «State Institute of Drugs and Good Practices» of the Ministry of Industry and Trade of the Russian Federation
  • Lev Dumchev, Head of Legal and Regulatory Affairs Department Department Eurasia, Bosnalijek JSC.
  • Natalia Falkovskaya, Head of Division for Registration, R-Pharm Group
  • Olesya Mertsalova, Head of Emerging Markets Region Regulatory Department, GlaxoSmithKline
Panel discussion
15:00–17:00
Pharmaceutical engineering. Integration, development of common rules and approaches (Presentations)
Parallel session!
Venue: Hall «Onyx»
Moderator: Igor Falkovskiy, the Head of the Department for Good Engineering Practice of the State Institute of Drugs and Good Practices
Issues to be discussed:
  • Integration of Good Engineering Practice into the Quality Management System
  • Impact of project quality upon the operation of pharmaceutical manufacturing
  • Interrelationship of engineering and quality in manufacturing
  • Practice of project management in construction of pharmaceutical sites of international companies in Russia
  • Pharma 4.0
  • Engineering for biotechnological manufacturing
Speakers:
  • Gerardo Briceño, Deputy minister of Resources, Technology and Regulation of Venezuela
  • Christian Woelbeling, Senior Director Global Accounts, Werum IT Solutions GmbH
  • Jens Peter Gundorf, Principal Specialist, Validation, Novo Nordisk A/S, Denmark
  • Oleg Spitskiy, specialist of the Engineering and Design Division,  State Institute of Drugs and Good Practices
  • Valeriy Aristov, Chief Quality Assurance Officer, JSC Pharmasyntez
  • Vitaliy Khilai, Discipline Engineer. Engineering & Maintenance, Bilfinger Tebodin CIS B.V.
  • Tatiana Viazmina, Quality director, R –Pharm
  • Alexander Kalentiev, Deputy Director, JSC National Engineering Corporation
Panel discussion
17:00–18:30
Medicines marking – approaching the finishing line
Parallel session!
Venue: Main hall
Moderators: Vladimir Shipkov, Executive Director, Association of International Pharmaceutical Manufacturers (AIPM) and Victor Dmitriev, Chief executive officer, Association of Russian Pharmaceutical Manufacturers (ARPM)
Issues to be discussed:
  • Readiness of market players of launching marking system of drugs – key issues on the agenda
  • Status of system readiness in program 7 of high-cost nosologies
  • Readiness of medical preventive institution, pharmacy and distributor chains
  • Ensuring the manufacturing stability and drugs supply
  • Practical recommendations. Company experiences.
  • Responsibility of drug circulation actors for violation of the marking requirements
  • International experience of launching projects on marking in the EU and China
Speakers:
  • Valentina Kosenko*, Deputy head, Federal Service for Surveillance in Healthcare
  • Elena Denisova, Deputy Director of the Department for the Pharmaceutical and Medical Industry Development of the Ministry of Industry and Trade of the Russian Federation
  • Dmitry Alkhazov*, Executive Director, CRPT LLC
  • Lilia Titova,  Executive Director, Union of Professional Pharmaceutical Organizations (SPFO)
  • Andrei Akhantiev, Director for Economic Security, Geropharm
  • Sergey Kuchiz, Deputy Chief Medical Officer for Prospective Development, State Budgetary Institution Konchalovsky City Clinical Hospital of Moscow City Health Department (Konchalovsky Clinic)
  • Nelly Ignatieva*, Executive Director, Russian association of pharmacy chains
  • Margarita Mustafina, Project Lead, Teva
  • Lev Dumchev, Head of Legal and Regulatory Affairs Department Department Eurasia, Bosnalijek JSC.
Panel discussion
17:00–18:30
The interrelationship of Good Practices: from development to distribution
Parallel session!
Venue: Hall «Onyx»
Moderators: Alfiya Gabidova, First Deputy Director, Moscow Endocrine Plant and Arina Selezneva, Deputy Head of Section for Good Practices, Federal State Institution «State Institute of Drugs and Good Practices» of the Ministry of Industry and Trade of the Russian Federation
Issues to be discussed:
  • Challenges of implementing Good Pharmacy Practice (GPP) in Russian and Eurasian Economic Union, their possible reasons and implications
  • Statutory documents in the system of regulatory lifecycle of drugs in Russian and Eurasian Economic Union
  • Ensuring the quality of pre-clinical trials of drugs from the Good Pharmacy Practice (GPP) perspective
  • Clinical trials in Russia: from harmonization of Good Clinical Practice (GCP) to recognition of the results of clinical trials abroad
  • Russia’s experience of implementing GMP in Russia. History of creating domestic GMP-inspectorate
  • Particularities of implementing Good Distribution Practice (GDP) in Russian and Eurasian Economic Union: ensuring the safety and quality of the pharmaceutical products during storage, distribution and transportation
  • Application of Good Pharmacovigilance Practice (GVP) in Russia and Eurasian Economic Union
  • World experience of implementing and applying Good Pharmacy Practice (GPP)
  • Ways of improving the regulatory lifecycle of drugs from the Good Pharmacy Practice (GPP) perspective
Speakers:
  • Dayana Priscila Paz Donoso, Technical Director of Good Practices and Permits of the General Coordination Certification Technique, National Agency for Regulation, Control and Sanitary Surveillance (ARCSA), Ecuador
  • Sergey Glagolev*, Deputy Head of the Division, Head of the Pharmacovigilance section of the Division for Organization of Quality Control for Medicines, Federal Service for Surveillance in Healthcare
  • Ekaterina Nikiforova, The Head of Drug Manufacture Inspections Department, Federal State Institution "State Institute of Drugs and Good Practices" of the Ministry of Industry and Trade of the Russian Federation
  • Roman Drai, Director for R&D, Geropharm
  • Anatoly Krasheninnikov, CEO at National Pharmacovigilance Research Center
  • Tatiana Viazmina, Quality director, R –Pharm
  • Valery Makarov, Doctor of Medical Sciences, Professor, Director of the Research Institutes Group
Discussion participants:
  • Jesus Herrera, Psychotropic coordinator, Autonomous Health Service Comptroller (SACS), Venezuela
  • Artur Valiev, Country Head, Sun Pharmaceuticals Russia
20:00–22:00
Evening reception
September 24, second day
08:30-9:00
Participants’ registration
09:00–09:30
Final of the competition «Quality Director»
Venue: Main hall
Winner's award ceremony
Panel discussion
09:30–11:00
GMP and Pharmacopoeia. Harmonization of main regulators’ tools
Parallel session!
Venue: Main hall
Moderator: Natalia Pyatigorskaya, Head of the Department of Industrial Pharmacy of the First Moscow State Medical University named after I.M. Sechenov, member of the Council for professional competence in the field of pharmacy, Doctor of Philosophy, Professor and Elena Popova, Senior Director for Regulatory Affairs and Health Policy, Association of International Pharmaceutical Manufacturers
Issues to be discussed:
  • Standardization and quality control of drugs in the Russian Federation
  • The concept of quality and approaches to its defining on the national level and in the EAEU legislation. Management of the drug’s life cycle
  • Control over the manufacturing and quality of pharmaceutical substances
  • Laboratory expertise upon the registration and entry into consumer markets. Quality control assessment, interrelationship with the GMP inspection. Transfer of the analytical methodologies.
  • Harmonization of regulatory requirements in current conditions. Industry viewpoint
  • Tests in vitro as an alternative to in vivo methods
  • Abnormal toxicity test – relevance of the method in the modern state of industrial development
Speakers:
  • Valentina Kosenko*, Deputy Director of the Federal Service for Surveillance in Healthcare
  • Gelena Grosheva, Head of section for Licensing and Inspections of Drug Manufacturing, Ministry of Industry and Trade of the Russian Federation
  • Elena Sakanyan, Chairman of the EEC pharmacopoeia committee
  • Dmitriy Rozhdestvenskiy, Head of the Division for Coordination of Work in the Sphere of Circulation of Medicines and Medical Devices of the Department of Technical Regulation and Accreditation of the EEC
  • Natalia Chadova, 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
  • Florence Benoit-Guyod, Head of the Manufacturing Site Inspection Directorate, European Directorate for the Quality of Medicines (EDQM), FranceElisabetta Montesoro, GMP Inspector, Italian Medicines Agency (AIFA)
  • Elena Kovaleva, 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
  • Igor Narkevich, Rector of the St. Petersburg State Chemical and Pharmaceutical University
  • Suzanne Osbourne, Head of Regional Regulatory Group, European Federation of Pharmaceutical Industry and Associations (EFPIA), Belgium
  • Soren Thuesen Pedersen, Senior Director, External Affairs, Quality Intelligence and Inspection, Novo Nordisk A/S
  • Stephan Roenninger, Director, Quality External Affairs, AMGEN (Europe) GmbH, Switzerland
  • Thorsten Herkert, Head of Compliance, Roche, Switzerland
Panel discussion
09:30–11:00
Global GMP trends – current initiatives, trends, best practices (Part 1)
Parallel session!
Venue: Hall «Yantar»
Moderator: Vladimir Orlov, Division lead, Division for International Cooperation of the Pharmaceutical Inspectorates, Federal State Institution State Institute of Drugs and Good Practices of the Ministry of Industry and Trade of the Russian Federation
Issues to be discussed:
  • Review of new initiatives in the legal framework of GxP in Europe and the world in 2018-2019
  • New version draft review of the Annex No. 1 GMP EU
  • Key theses and regulations of new guidelines ICH Q12 (Pharmaceutical Product Lifecycle Management)
  • Events, conducted by PIC/C for the purpose of the GMP inspection procedures harmonization/ Review of PIC/S Guidance on Classification of GMP Deficiences. Mutual recognition of inspection results
  • Key provisions of the new guideline ICH Q3D(R1) «GUIDELINE FOR ELEMENTAL IMPURITIES» as on 2019
  • Practical application of the EMA guidelines on choosing sterilization method for drugs
  • Review of the new version Annex No. 17 GMP EU «Parametric release»
  • The role of EDQM in the circulation system of reference standards of the European Pharmacopeia
  • Review of key trends following the inspection results of inspecting Active Pharmaceutical Ingredients (API) manufacturers from by EDQM
Speakers:
  • Shingou Sakurai, Senior Director of entire Manufacturing Quality and Compliance function, Pharmaceutical and Medical Devices Agency (PMDA), Japan
  • Ferenc Lukács, Head of Department, Directorate for Inspection, Drug Inspectorate, National Institute of Pharmacy and Nutrition (OGYÉI), Hungary
  • Nadezhda Arkhipova, Deputy Head of Expertise Department, Federal State Institution «State Institute of Drugs and Good Practices» of the Ministry of Industry and Trade of the Russian Federation
  • Stephan Roenninger, Director, Quality External Affairs, AMGEN (Europe) GmbH, Switzerland
  • Pierre Winnepenninckx, CEO and Founder, No Deviation, Singapore
Discussion Panelists:
  • Saeedeh Fakhrzadeh, Expert of biologicals, Head of vaccine division in Biologic Department, Food and Drug Administration, Ministry of Health and Medical Education, Islamic Republic of Iran
  • Izabela Majic, Global quality director, Dechra/HALMED, Croatia
  • Josef Kriegl, Managing Director, Chemgineering International GmbH, Member of the Supervisory Board of the ISPE DACH, Austria
Partnering discussion
09:30–11:30
Modernization of the pharmaceutical healthcare sector on a regional level. Particularities of the drug supply system in Russia’s regions
Parallel session!
Venue: Hall «Onyx»
Moderators: Victor Dmitriyev, Chief executive officer, the Association of the Russian Pharmaceutical Manufacturers (ARPM) and Alexander Kravchenko, Minister of Heatlh of the Kaliningrad region
Issues to be discussed:
  • Interim results of procurement campaign 2018-2019
  • Regional specialties of drug procurement. Finding the common ground between customer and end consumer within the Federal Act № 44
  • Identification and suppression of cartels and other anticompetitive agreements in the field of drugs supply and medicinal products. Administrative and arbitral practice.
Speakers:
  • Mikhail Murashko*, Head of the Federal Service for Surveillance in Healthcare
  • Elena Maksimkina*. Director of the Department of Drug Supply and Regulation of Medical Devices at the Ministry of Health of the Russian Federation
  • Alexey Alekhin*, Director of the Department of Pharmaceutical and Medical Industry of the Ministry of Industry and Trade of the Russian Federation
  • Ekaterina Konopkina, Head of section for law enforcement practice and methodology, Anti-Cartel Department, Federal Antimonopoly Service of the Russian Federation
  • Ramil Khabriev, Director, National Research Institute of Public Health named after N.A. Semashko, Academic of the Russian Academy of Science
  • Dmitry Kordyumov, First deputy chairman of the government  Председателя of the Kirov region
  • Alexander Khajidis, Chief clinical pharmacologist of St. Petersburg, President of Professional Medical Association of clinical pharmacologists of St. Petersburg
  • Ekaterina Korjos, Senior prosecutor for supervision of the federal legislation of the Kaliningrad region
  • Ekaterina Eliseeva, Vice-chancellor, Vladivostok State Medical University of the Ministry of Health of the Russian Federation
  • Ekaterina Zadonskaya, Managing Director, Cursor Marketing
  • Ilya Vesker, Director for the product market access and programmes for supporting patients, Takeda
11:00-11:30
Break
Panel discussion
11:30–13:00
Global GMP trends - current initiatives, trends, best practices (Part 2)
Parallel session!
Venue: Hall «Yantar»
Moderator: Vladimir Orlov, Division lead, Division for International Cooperation of the Pharmaceutical Inspectorates, Federal State Institution State Institute of Drugs and Good Practices of the Ministry of Industry and Trade of the Russian Federation
Issues to be discussed:
  • Review of new initiatives in the legal framework of GxP in Europe and the world in 2018-2019
  • New version draft review of the Annex No. 1 GMP EU
  • Key theses and regulations of new guidelines ICH Q12 (Pharmaceutical Product Lifecycle Management)
  • Events, conducted by PIC/C for the purpose of the GMP inspection procedures harmonization/ Review of PIC/S Guidance on Classification of GMP Deficiences. Mutual recognition of inspection results
  • Key provisions of the new guideline ICH Q3D(R1) «GUIDELINE FOR ELEMENTAL IMPURITIES» as on 2019
  • Practical application of the EMA guidelines on choosing sterilization method for drugs
  • Review of the new version Annex No. 17 GMP EU «Parametric release»
  • The role of EDQM in the circulation system of reference standards of the European Pharmacopeia
  • Review of key trends following the inspection results of inspecting Active Pharmaceutical Ingredients (API) manufacturers from by EDQM
Speakers:
  • Florence Benoit-Guyod, Head of the Manufacturing Site Inspection Directorate, European Directorate for the Quality of Medicines (EDQM), France
  • Shingo Sakurai, Senior Director of entire Manufacturing Quality and Compliance function, Pharmaceutical and Medical Devices Agency (PMDA), Japan
  • Ivan Bašic, GMP Inspector Expert, Croatian Agency for Medicinal Products and Medical Devices (HALMED)
  • Marta de Vicente, Pharmaceutical Inspector, Inspection Area, Pharmaceutical Inspection and Enforcement Department, Spanish Agency of Medicine and Sanitary Products (AEMPS)
  • Natalia Popova, Director of Quality Assurance, Abbott
Discussion Panelists:
  • Saeedeh Fakhrzadeh, Expert of biologicals, Head of vaccine division in Biologic Department, Food and Drug Administration, Ministry of Health and Medical Education, Islamic Republic of Iran
  • Izabela Majic, Global quality director, Dechra/HALMED, Croatia
  • Josef Kriegl, Managing Director, Chemgineering International GmbH, Member of the Supervisory Board of the ISPE DACH, Austria
Panel discussion
11:30-13:00
Prospects for organizing the GMP production of radiopharmaceuticals in Russia
Parallel session!
Venue: Hall «Onyx»
Moderator: Sergey Razumov, Adviser to General Director, JSC Rusatom Healthcare
Issues to be discussed:
  • Radiopharmaceutical products in Russia: state of the industry, main challenges and ways to overcome them
  • Development tendencies in manufacturing and radiopharmaceutical market in Russia and the world
  • Review of medical facilities’ requirements in diagnostic and therapeutic radiopharmaceutical products in Russia
  • Nuclear medicine in Russia and in the world – priority area of scientific and technical development
  • Special requirements for circulation and manufacturing of radiopharmaceutical products. Experience of implementing good practices in the industry – Russia and EAEU
  • Experience of Karpov Scientific Research Institute of Physics and Chemistry (NIFKHL) in manufacturing of radiopharmaceuticals and raw isotopes for the domestic market and exports
Speakers:
  • Elena Denisova, Deputy Director of the Department for the Pharmaceutical and Medical Industry Development of the Ministry of Industry and Trade of the Russian Federation
  • Alexander Zverev, Branch Director, «Zavod «Medradiopreparat», the branch of FSUE «Federal center of nuclear medicine projects design and development» of FMBA of Russia
  • Oleg Kononov, Director of the JSC Karpov Institute of Physical Chemistry
  • Elena Zelinskaya, GMP expert, IBA
  • Maksim Smolyarchuk, Deputy Chief External Expert for Radionuclide Diagnostics of remotely sensed radioactive materials, Head of Radiation Diagnostics Department at Hadassah Skolkovo
13:00-14:00
Break
Panel discussion
14:00–15:30
Manufacturing of sterile medicinal products. Ensuring the aseptic manufacturing. Role of Pharmacopeia standards
Parallel session!
Venue: Main hall
Moderator: Elena Popova, Senior Director for Regulatory Affairs and Health Policy, Association of International Pharmaceutical Manufacturers
Issues to be discussed:
  • Approaches to GMP inspections of biological products – strategy of control of the sterilization filtration
  • EMA guidelines on sterilization of drugs, active pharmaceutical ingredients and auxiliary substances, primary packaging – choice of method for biological products
  • GMP inspection of biological products manufacturing – particularities of manufacturing biological products
  • Modernization of aseptic technologies. New generation of the new aseptic bottling line (case study)
  • Sterilization filtration – quality assurance of the manufacturing process and safety evaluation of the executed method
  • Control strategy of general monographs and finished biotherapeutic medicinal product and release to the global market.
Speakers:
  • Valentina Kosenko*, Deputy Director of the Federal Service for Surveillance in Healthcare
  • Gelena Grosheva, Head of section for Licensing and Inspections of Drug Manufacturing, Ministry of Industry and Trade of Russia
  • Elena Kovaleva, 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
  • Natalia Chadova, Head of Department on Drug Product Inspection and Expert Evaluation, «SID&GP»
  • Florence Benoit-Guyod, Head of the Manufacturing Site Inspection Directorate, European Directorate for the Quality of Medicines (EDQM), France
  • Elisabetta Montesoro, GMP Inspector, Italian Medicines Agency (AIFA)
  • Suzanne Osbourne, Head of Regional Regulatory Group, European Federation of Pharmaceutical Industry and Associations (EFPIA), Belgium
  • Stephan Roenninger, Director, Quality External Affairs, AMGEN (Europe) GmbH, Switzerland
  • Henrik Friese, Corporate Vice President, Quality Intelligence and Inspections, Novo Nordisk A/S
Panel discussion
14:00–16:00
Issues of regulating production and circulation of veterinary medicines
Parallel session!
Venue: Hall «Onyx»
Moderator: Danil Rudnyaev, Head of section for manufacturing inspection for the GMP conformity, The Russian State Center for Animal Feed and Drug Standardization and Quality
Issues to be discussed:
  • Legal aspects of drug circulation for veterinary use in the EAEU customs territory
  • Challenges in abolishing technical regulation in the field of drug circulation for veterinary use and ways to overcome them
  • Quality control of drugs for veterinary use
  • Organization and procedure for inspection of drug manufacturers for veterinary use. Particularities, statistical data
  • Particularities of organizing and conducting inspections of manufacturers (foreign manufacturers) of immunobiological drugs for veterinary use on the territory of the USA. Legal framework.
Speakers:
  • Anna Babushkina, Deputy head of section for internal veterinary supervision, Federal Service for Veterinary and Phytosanitary Surveillance
  • Steven A. Karli, Inspection and Compliance. Center for Veterinary Biologics, United States Department of Agriculture
  • Anna Smolina, chief expert of the Section for veterinary measures of the Department for Department for Sanitary, Phytosanitary and Veterinary Measures
  • Leonid Kish*, Director, Federal Service for Veterinary and Phytosanitary Surveillance
  • Vincent Neuviale, Inspector of manufacturers and distributors of veterinary medicinal products (VMP), The French Agency for Veterinary Medicinal Products (ANMV)
  • Tadas Briedis, Counsellor for agriculture, EU Delegation to the Russian Federation
Workshop
15:30–17:30
GMP inspection. Part 1
Parallel session!
Venue: Main hall
Moderators: Elena Denisova, Deputy Director of the Department for the Pharmaceutical and Medical Industry Development of the Ministry of Industry and Trade of the Russian Federation and Natalia Chadova, 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
Issues to be discussed:
  • Follow-up inspections of manufacturing sites: preparation of CAPA plans and their implementation
  • Process validation – current regulatory requirements, their implementation and evaluation during the course of inspection
  • Risk-based approach to classification of identified non-conformities with the GMP. Regulatory tendencies and examples from practice
Speakers:
  • Jesus Herrera, Psychotropic coordinator, Autonomous Health Service Comptroller (SACS), Venezuela
  • Elisabetta Montesoro, GMP Inspector, Italian Medicines Agency (AIFA)
  • Archiraya Prysuwan, Pharmacist, GMP Chief Inspector, Food and Drug Administration (TFDA), Thailand
  • Ivan Bašic, GMP Inspector Expert, Croatian Agency for Medicinal Products and Medical Devices (HALMED)
  • Chantal Cazeault, Executive Director, Product Quality, Amgen, USA
  • Olga Maklakova, Quality Director, Akrikhin
  • Irina Nikitina, Quality director, Geropharm
  • Izabela Majic, Global quality director, Dechra/HALMED, Croatia
  • Stephan Roenninger, Director, Quality External Affairs, AMGEN (Europe) GmbH, Switzerland
  • Heinz Schmidt, General Manager R&A Russia & CIS, Life Science, MERCK
Discussion Panelists:
  • Julia Grishina, 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
  • Nikita Novikov, 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
  • Vitaliy Kazulkin, Senior 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
Panel discussion
16:00–18:00
Principles of organization of the pharmacovigilance system by a medicines manufacturer. The results of two years operation of pharmaceutical companies in the GVP system
Parallel session!
Venue: Hall «Onyx»
Moderators: Anatoly Krasheninnikov, Director, National Pharmacovigilance Research Center and Dmitry Rozhdestvenskiy, Head of the Coordination department in the field of drugs and medical products circulation of the Department of technical regulation and accreditation, Eurasian Economic Commission
Issues to be discussed:
  • Key directions of government policy in the field of medicinal security
  • Requirements of the pharmacovigilance system within the expertise of the registration dossier’s set of documents
  • Key principles and recommendations to the marketing authorizations` holders on report preparations regarding drug safety
  • Common requirements for organizing the pharmacovigilance system in the EAEU.
  • Main challenges in organizing the pharmacovigilance inspection system of domestic manufacturers
  • Main trends of specialists training on the pharmacovigilance in the GVP system
Speakers:
  • Valentina Kosenko*, Deputy head, Federal Service for Surveillance in Healthcare
  • Sergey Glagolev*, Deputy Head of the Division, Head of the Pharmacovigilance section of the Division for Organization of Quality Control for Medicines, Federal Service for Surveillance in Healthcare
  • Boris Romanov, Deputy scientific director, Scientific Centre for expert evaluation of medicinal products of the Russian Ministry of Health
  • Svetlana Setkina, Deputy director, Center for Examinations and Tests in Health Service, The Republic of Belarus
  • Marina Durmanova, President, Association for Pharmaceutical Activities Support and Development of the Republic of Kazakhstan
  • Nadezhda Daragan, Chairman of the Coordination Council, National Association of manufacturers of pharmaceutical products and medical devices
  • Natalia Pyatigorskaya, Head of the Department for Industrial Pharmacy, I.M. Sechenov First Moscow State Medical University, Member of the Council for professional qualifications in pharmacy
  • Airat Farrakhov*, Member of Parliament of The State Duma of the Russian Federation Federal Assembly of VII legislature, State Advisor of the Russian Federation of the 4rd class, M.D., Honored doctor of the Republic of Tatarstan
  • Ivan Kirichenko, Head of the medical department, Infamed K
Panel discussion
17:30–19:00
Confirmation of conformity with GMP as part of the transition to the single market
Venue: Main hall
Moderator: Vladislav Shestakov, Director, Federal State Institution «State Institute of Drugs and Good Practices» of the Ministry of Industry and Trade of the Russian
Issues to be discussed:
  • Transition period. What manufacturer has to do in order to get a document, confirming the conformity with GMP: current status of legislation of EEC member-states
Speakers:
  • Madina Sottayeva, Head of Division for International Cooperation of the Pharmaceutical Inspectorates, Head of Department for inspection of medicines and expertise, Federal State Institution State Institute of Drugs and Good Practices of the Ministry of Industry and Trade of the Russian Federation
  • Mkrtich Shakaryan, Head of Division for Good Pharmacy Practice,  Scientific Center of Drug and Medical Technologies Expertise after academician Emil Gabrielyan, Armenia
  • Tatiana Tumelya, Deputy Director, Unitary Enterprise Center of Expertise and Testing in Healthcare, Republic of Belarus
  • Nurlybek Asylbekov, Deputy Chairman of the Committee for control of quality and safety of products and services, Ministry of Health of the Republic of Kazakhstan
  • Iskhak Toktonaliev, Leading specialist of Good Pharmacy Practices (GPC) at the Department for Medication Supply, Ministry of Health of the Republic of Kyrgyzstan
  • Vladimir Shipkov, Executive Director of the Association of International Pharmaceutical Manufacturers (AIPM)
  • Lilia Titova, Executive Director of The Society of Professional Pharmaceutical Organizations
  • Boris Pleten, Manager for registration of the Department for registration, Gedeon Richter
September 25, third day
Pharma-law session
9:00-10:30
Current tendencies in the field of regulation of drug production
Venue: Hall «Onix»
Moderator: Irina Pshenichnaya, 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
Issues to be discussed:
  • Legal issues regarding the organization of pharmaceutical inspectorate in Russia and Eurasian Economic Union: challenges and possible solutions
  • «Regulatory guillotine» and control and monitoring activities in the field of drug manufacturing
  • Application of administrative enforcement measures in the cases of non-conformity with the requirements for GMP rules
  • Legal implications of non-conformity with GMP rules for the entities of drugs circulation
  • How to protect rights during the registration of generics: issues for concern in the context of the requirements for the legislation of the Eurasian Economic Union
  • Authorized personnel, transition to the new requirements and attestation rules
Speakers:
  • Natalia Putilo, Head of the Department of Social Legislation, Institute of Legislation and Comparative Law under the Government of the Russian Federation
  • Anastasia Kalmykova, Senior Research Fellow of section for administrative law and administrative procedure Institute of Legislation and Comparative Law under the Government of the Russian Federation
  • Pavel Kabytov, Senior Research Fellow of section for administrative law and administrative procedure Institute of Legislation and Comparative Law under the Government of the Russian Federation
  • Alexander Prepyalov, Director, LLC Gringo
  • Elena Popova, Senior Director for Regulatory Affairs and Health Policy, Association of International Pharmaceutical Manufacturers
  • Natalia Pyatigorskaya, Head of the Department for Industrial Pharmacy, I.M. Sechenov First Moscow State Medical University, Member of the Council for professional qualifications in pharmacy
  • Pavel Sukholinsky, Senior legal officer, law firm Egorov Puginsky Afanasiev & Partners
Panel discussion
9:00-10:30
Current issues of manufacturing blood derived medicinal products
Parallel session!
Venue: Hall «Yantar»
Moderator: Olga Eichler, Head of the Blood Service Department of the Federal Medical and Biological Agency (FMBA)
Issues to be discussed:
  • Centralization, standardization of technologies of blood banking and its components
  • Adoption of a single inter-laboratory quality control
  • Domestic production of blood-derived products. Depth of production localization
  • Regulatory issues on registration and circulation control of blood-derived products in the market
Speakers:
  • Alexander Khokhryakov, Deputy General Director for Medical Activity of the Federal State Budgetary Institution of the Russian Medical Center Rosplasma Federal Medical and Biological Agency
  • Saeedeh Fakhrzadeh, Expert of biologicals, Head of vaccine division in Biologic Department, Food and Drug Administration, Ministry of Health and Medical Education, Islamic Republic of Iran
  • Elena Sakanyan, Chairman of the EEC pharmacopoeia committee
  • Alexander Poptsov, Head of Quality Service, PhD in Medical Sciences, the Federal State Budgetary Institution of the Russian Medical Center Rosplasma Federal Medical and Biological Agency
  • Sergey Goryunov, Chairman of the Board of Directors, Immuno-Gem LLC
  • Evgeny Shepodko, Director of Legal and HR Department, PHARMIMEX JSC
  • Elena Petrova, Technical Director, Head of the Representative Office of JSC Kedrion S.p.A.
  • inIlya Vesker, Director for the product market access and programmes for supporting patients, Takeda
Discussion Panelists:
  • Yuriy Tyurikov, Director, Ivanovo Regional Blood Transfusion Station
10:30–10:45
Break
Workshop
10:45-12:45
GMP-inspection. Part 2
Venue: Hall «Yantar»
Moderators: Elena Denisova, Deputy Director of the Department for the Pharmaceutical and Medical Industry Development of the Ministry of Industry and Trade of the Russian Federation and Natalia Chadova, 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
Issues to be discussed:
  • Conformity with the requirements of registration dossier as one of the key assessment aspects when conducting GMP inspections
  • Particularities of the GMP requirements for API manufacturing and their assessment during an inspection
  • Modern regulatory requirements for preventing cross-contamination at the pharmaceutical manufacturing. Wishful thinking of inspectors and the practice of inspecting
Speakers:
  • Marta de Vicente, Pharmaceutical Inspector, Inspection Area, Pharmaceutical Inspection and Enforcement Department, Spanish Agency of Medicine and Sanitary Products (AEMPS)
  • Maram Darag, Head of the manufacturing site inspection, Egyptian Drug Authority (EDA), Ministry of Health (MOH)
  • Nuray Mukhtarova, Senior specialist, Department of quality control laboratory of medicines of Analytical Expertise Center, the Ministry of Health of the Azerbaijan Republic
  • Dayana Priscila Paz Donoso, Technical Director of Good Practices and Permits of the General Coordination Certification Technique, National Agency for Regulation, Control and Sanitary Surveillance (ARCSA), Ecuador
  • Elena Kovaleva, 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
  • Tatiana Vyazmina, Quality Director, R-Pharm Group
  • Natalia Volovich*, Deputy Director, Head of the Department for Registration of the OJSC Gedeon Richter Representative Office
Discussion Panelists:
  • Vladimir Smirnov, Senior 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
  • Vyacheslav Goryachkin, Head of Good Practices Department, Federal State Institution «State Institute of Drugs and Good Practices» of the Ministry of Industry and Trade of the Russian Federation
  • Egor Rybakov, 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
* – speaker/topic TBC