Всероссийская GMP-конференция | Program
Program
September 30, Day 1
9:30–10:00
Conference opening
Plenary session
10:00–12:00
Pharmaceutical and medical industry: lessons from the pandemic
Issues to be discussed:
  • Special conditions for the development, manufacturing, registration and further movement of new medicines during the pandemic
  • Experience of industry and regulator under special conditions. Consolidation of joint work efforts
  • Interagency interaction in the fight against coronavirus COVID-19 infection
  • Preparedness of health systems for pandemic: world experience and the experience of the EAEU countries
Moderators:
  • Vladislav Shestakov, Director of the State Institute of Drugs and Good Practices
  • Anfisa Voronina, Chief editor, Vedomosti &
Invited speakers:
  • Mikhail Murashko *, Minister of Health of the Russian Federation
  • Sergey Tsyb*, First Deputy Minister of Industry and Trade of the Russian Federation
  • Alla Samoylova *, Head of the Federal Service for Surveillance in Healthcare (Roszdravnadzor)
  • Dzhanyl Dzhusupova, Deputy Director of the Technical Regulation and Accreditation Department of the Eurasian Economic Commission
  • Ferenc Lukács, Inspectorate Head, National Institute of Pharmacy and Nutrition (OGYÉI)
  • Domenico Di Giorgio, Head of Inspectorate, Italian Medicines Agency (AIFA), “Inter-agency cooperation in combatting the pandemic COVID -19”
  • Kuramochi Kenji, Director, Office of Manufacturing Quality for Drugs, Pharmaceutical and Medical Devices Agency (PMDA) of Japan, “GMP Inspection under the covid-19 pandemic in Japan”
  • Guillaume Dedet, Health Policy Analyst, OECD Health Division, “Medicine shortages: the global situation and impact of the COVID-19 global pandemic”
  • Jérôme Lepeintre, 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»
  • 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”
  • Marwan Akar, Managing Director of MSD Pharmaceuticals LLC, Managing Director of MSD in Russia, Belarus and Kazakhstan
12:00–12:15
Break
Panel discussion
12:15–14:15
Present and future of the EAEU countries single market integration
Issues to be discussed:
  • The experience of the EAEU Member States’ path of joining the PIC/S (Republic of Armenia)
  • Balance of Eurasian and national requirements in the EAEU Member States (Republic of Armenia)
  • Creation of integration mechanisms for implementation of the requirements within the EAEU single market functioning
  • Pharmacopoeia standardization discussion issues: "Сomposite sample" and other problems of ambiguous interpretation of the OOS results in pharmacopoeia analysis
  • Eurasian procedure of special drugs’registration. Harmonization of registration procedure for radiopharmaceuticals
  • Experience of undergoing inspections and registering medicinal products according to the EAEU rules
Moderator: Popova Elena, Senior Director Regulatory Affairs & Healthcare Policy, Association of International Pharmaceutical Manufacturers (AIPM)
Invited speakers:
  • Aleksey Alekhin, Director of the Department for pharmaceutical and medical industry development, Ministry of Industry and Trade of the Russian Federation
  • Natalia Volovich, Deputy Director, Head of Registration Department of the Gedeon Richter Representative Office
  • Anna Kravchuk, 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”
  • Margarita Mustafina, Quality Director, Russia and Eurasia. Teva
  • Stanislav Naumov, Chairman of the Board of the Eurasian Economic Union Association of Pharmaceutical Manufacturers
  • Natalya Podgorbunskih*, Deputy general director, Pharmstandard
  • Dmitry Poputnikov, Chief specialist of the GMP Inspectorate, “Centre for Expertise and Testing”, Republic of Belarus
  • Stephan Roenninger, Director of Quality and External Affairs, Amgen, Switzerland
  • 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) Pharmacopoeia standardization discussion issues: "Сomposite sample" and other problems of ambiguous interpretation of the OOS results in pharmacopoeia analysis
  • Madina Sottayeva, Deputy Head of the Department for Cooperation with the EAEU countries, Pharmaceutical Production Inspection Department, State Institute of Drugs and Good Practices
  • Tatiana Tumelya, Deputy Director of the Republican Unitary Enterprise "Center for Examinations and Tests in Health Service", Republic of Belarus
  • Raushan Turysbekova, Head of Section of the evaluation of manufacturing for conformity with GMP, National center of expertise for drugs and medical devices of the Committee for quality and safety control of goods and services of the Ministry of Health of the Republic of Kazakhstan
  • Mkrtich Shakaryan, Head of Division for Good Pharmacy Practice, Scientific Center of Drug and Medical Technologies Expertise after academician Emil Gabrielyan, Armenia
  • Rufat Yansupov, Counsellor to the General Director for Quality, Scientific Research Institute of Physics and Chemistry named after L.Y. Karpov (Rosatom)
Session’s partner: PRO.MED.CS Praha a.s. company
14:15–14:30
Break
Panel discussion
14:30-16:00
Potential of API local manufacturing and current practices of local manufacturing
Parallel event!
Issues to be discussed:
  • Challenges of organizing global supply chains of pharmaceutical substances during the pandemic
  • Development prospects of local manufacturing of a wide range of pharmaceutical substances in the Russian Federation
  • Ways to overcome the dependence of the local pharmaceutical market on the raw materials supplies from the Southeast Asia
  • Main criteria for forming the government strategy for the development of national substances manufacturing
  • Manufacturing of reference samples
  • Issues of impurities indication in FPP (e.g. nitrosamines, sartans)
Moderator: Aleksey Alekhin, Director of the Department for pharmaceutical and medical industry development of the Ministry of Industry and Trade of the Russian Federation
Invited speakers:
  • Astafurov Oleg, Vice-President for Government Relations of "Pharmasyntez" company “Prospects for development of local manufacturing of a broad assortment of pharmaceutical substances in Russia”
  • Vladimir Gegechkori, Leading Specialist of the Good Practices Division, State Institute of Drugs and Good Practices
  • Krishnarajan Bangarurajan, Regulatory Affairs Advisor, The Central Drugs Standard Control Organisation (CDSCO) “Potential for API manufacturing”
  • Valeriy Mandrovsky, Executive Director, Long Sheng Pharma Rus LLC
  • Olesya Polyanskaya, Communications Director, The Society of Professional Pharmaceutical Organizations
  • Natalia Popova, Division Director for Quality and Compliance, Abbott Pharmaceuticals Division “Modelling of aseptic process with the use of digest medium”
  • Eduard Savin*, Director for development, NC Pharm
  • Alexander Semenov, President of JSC “Acticomp” “Ways to overcome the dependence of the local pharmaceutical market on the raw materials supplies from the Southeast Asia”
  • Ludmila Shcherbakova, General Director of Veltrrade (Welpharm)
  • EDQM representative “Issues of impurities indication in FPP (e.g. nitrosamines, sartans)”
Session’s partner: “Pharmasyntez” company
Roundtable discussion
14:30-16:00
The future of local pharmaceutical industry specialists
Parallel event!
Issues to be discussed:
  • Prospects for industrial practices in the training of students of the Faculty of Pharmacy
  • A distinctive role of continuing professional education during the pandemic. Effective mechanisms for personnel retraining and professional development
  • The Academy of Inspectorates as a resource for ensuring expert and narrowly specialized education in the field of GxP
  • Intellectual resources of pharmaceutical companies as a basis for innovative development and competitiveness on the market
  • Strategy of the leading Russian universities in the context of current challenges of the time
Moderators:
  • 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
  • Anatoly Krasheninnikov, Director's advisor, State Institute of Drugs and Good Practices, Head of the Pharmacy Department at the Pirogov Russian National Research Medical University
Invited speakers:
  • Ivan Guliaev, 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”
  • Gortinskaya Viktoria, Moderator of the joint programme of the State Institute of Drugs and Good Practices and Pharmstrategy LLC
  • Igor Narkevich, Rector of Saint Petersburg State Chemical Pharmaceutical University
  • Representative of Higher School of Economics
  • Representative of BIOCAD company
Closed event
14:30-16:00
Meeting of Russian pharmaceutical manufacturers with Trade missions of the Russian Federation
Parallel event!
Issues to be discussed:
  • Experience of Russian Trade Missions in the framework of export strategy during the pandemic
  • Countries overview and market conditions
  • States’ needs for pharmaceutical products
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
  • Vladislav Shestakov, Director of the State Institute of Drugs and Good Practices
Invited speakers:
  • Bogatyr Alexander, Trade Representative of Russia in Cuba
  • Baldin Sergey, Leading expert of Russian Trade mission in Cuba
  • Vadim Dolgopolov, Chief expert of Russian Trade mission in China
  • Andrey Makarov, Trade Representative of Russian in Netherlands
  • Rybas Alexander, Trade Representative of Russia in India
  • Artyom Tsinamdzgvrishvili, Trade Representative of Russia in Morocco
  • Viktor Sheremetker, Deputy Trade Representative of Russia in Brazil
Pre-registration is required
Roundtable discussion
14:30-16:00
Current trends in global legislation and global harmonization
Parallel event!
Issues to be discussed:
  • Role and responsibilities of marketing authorization holders from the perspective of modern GMP requirements. Topical issue and ways of resolving. Position of the EU regulatory authoritites (EMA)
  • Main provisions of the new version of Annex draft No. 16 GMP EAEU from the point of view of the GMP requirements and the Qualified person job in pharmaceutical enterprise
  • Approaches and methods for studying the medicines stability in the EAEU law
  • New European guidelines for water treatment quality: should the EAEU guidelines be updated?
Moderators:
  • Gelena Grosheva, Head of section for licensing and inspection of drugs manufacturing, Department of Pharmaceutical and Medical Industry Development of the Ministry of Industry and Trade of the Russian Federation
  • Orlov Vladimir, Director of the ISPE Eurasian Affiliate
Invited speakers:
  • Alexander Belinsky, Head of the Validation Department of Labpromengineering LLC “New European guidelines on quality of water treatment: should EAEU guidelines be updated?”
  • Tatiana Vyazmina, 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”
  • 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) “Approaches and methods for studying the medicines stability in the EAEU law”
  • Olga Solovyova, Development Director of Legispharm LLC “Role and responsibilities of marketing authorization holders from the perspective of modern GMP requirements. Topical issue and ways of resolving. Position of the EU regulatory authorities (EMA)”
Session’s partner: PRO.MED.CS Praha a.s. company
16:00–16:15
Break
Roundtable discussion
16:15–17:45
Interdisciplinary approach for innovation and export potentials for the development of the EAEU pharmaceutical industry
Parallel event!
Issues to be discussed:
  • GLP and bioequivalence studies: requirements for testing laboratories that perform bioanalytical (laboratory) studies of medicines
  • Peculiarities of the development and registration of medicines and the potential of local original medicines
  • Recognition of the local GLP regulation system at the international level. The model of effective GLP regulation from the perspective of Good Pharmaceutical Practices in the EAEU
  • GMP-evaluation of manufacturing facilities for clinical trials
  • Pre-registration expertise of Module 3 "Quality" set of documents
  • Relationship between GDP rules and licensing of pharmaceutical activities
Moderator: Roman Drai, Director of R&D Center, Geropharm
Invited speakers:
  • Anna Galustova, Head of section for Quality assurance, Research Institute of Chemical Dicersity, "ChemRar" High-Tech center. “GMP-evaluation of manufacturing facilities for clinical trials”
  • Vyacheslav Goryachkin, Head of the Good Practices Division, State Institute of Drugs and Good Practices “Experience of conducting GMP audits”
  • Kazey Vasily, General Director of " Exacte Labs" Ltd.
  • 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. “Pre-registration expertise of Module 3 "Quality" set of documents”
  • Valentina Kosenko, Deputy Head of Federal Service for Surveillance in Healthcare (Roszdravnadzor)
  • Valery Makarov, General Director, St. Petersburg Pharmacy Institute.
  • Martin Reed, GLP & GMP QC Inspector, Medicines & Healthcare Products Regulatory Agency
  • Arina Selezneva, Deputy Head of Section for Good Practices, State Institute of Drugs and Good Practices
  • Vladimir Smirnov, Senior Specialist of the Pharmaceutical Production Inspection Division, State Institute of Drugs and Good Practices
  • Igor Shokhin, General Director of "Center of Pharmaceutical Analytics"
  • Representative of Gedeon Richter Rus.
Roundtable discussion
16:15–17:45
Continuous manufacturing
Parallel event!
Issues to be discussed:
  • Regulator’s perspective in relation to introducing modern technologies
  • Importance of introducing modern technologies
  • ICH Q13 and technological solutions “continuous manufacturing”
  • CM elements for oral solid dosage process
  • Case study. Development of CM for API manufacturing
  • CM from inspector’s perspective
Moderator: Igor Falkovskiy, the Head of the Department for Good Engineering Practice of the State Institute of Drugs and Good Practices
Invited speakers:
  • Aleksey Alekhin, Director of the Department for pharmaceutical and medical industry development, Ministry of Industry and Trade of the Russian FederationRegulator’s perspective in relation to introducing modern technologies”
  • Mohammed Ali Dahhas, Executive Director of Inspection Support, Saudi Food and Drug Authority “Regulator’s perspective in relation to introducing modern technologies”
  • Christine Moore, Global Head and Executive Director, GRACS CMC – Policy, MSD, “ICH Q13 and technological solutions “continuous manufacturing”
  • Polstyanov Dmitriy, Executive director, X-Tech “CM elements for oral solid dosage process”
  • Mikhail Genkin, GSM Chemical «Case study. Development of CM for API manufacturing” “Case study. Development of CM for API manufacturing”
  • Socrates Kyritsis, 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”
Session’s partner: NANOLEK company
17:45–18:00
Break
18:00–18:20
Closing ceremony
October 1, Day 2
Workshop “New formats of GMP-inspections”
10:00–12:00
Introductory part
  • Regulatory framework and experience of inspecting pharmaceutical manufacturers for the compliance with GMP rules during the pandemic
  • Exchange of experience with representatives of foreign pharmaceutical inspectorates
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
  • Natalia Chadova, Head of Department on Drug Product Inspection and Expert Evaluation, State Institute of Drugs and Good Practices
Invited speakers:
  • Mohammed Ali Dahhas, Executive Director of Inspection Support, Saudi Food and Drug Authority “SFDA Experience In GMP Inspections during Covid-19 pandemic”
  • Nadezhda Arkhipova, Deputy Head of Expertise Department, Federal State Institution State Institute of Drugs and Good Practices
  • Rauf Afandiyev, Senior Quality Specialist, Analytical Expertise Center Ministry of Health - Azerbaijan Republic
  • Krishnarajan Bangarurajan, Regulatory Affairs Advisor, The Central Drugs Standard Control Organisation (CDSCO)
  • Ferenc Lukács, Inspectorate Head, National Institute of Pharmacy and Nutrition (OGYÉI) “Challenges during the crisis of the pandemic and new formats of GMP-inspections”
  • Luis Ignacio Perez- Ordoyo, GMDP inspector, Spanish Agency of Medicine and Sanitary Products (AEMPS)
  • Stephan Roenninger, Director of Quality and External Affairs, Amgen, Switzerland, “Changing Inspections Landscape in the New Environment”
  • Indira Fazlagic, Head of Inspectorate, Agency for medicinal products and medical devices Bosnia and Herzegovina “New formats of GMP-inspections”
  • Marla A. Phillips, Director, Xavier Health, Xavier University (USA)
  • Wesal Haqaish, Drug Directorate Director, Jordan Food and Drug Administration (JFDA) “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”
  • Myung-hoon Chung, Deputy Director, Pharmaceutical Quality Division, Pharmaceutical Safety Bureau, Ministry of Food and Drug Safety (video-presentation)
Session’s partner: “Akrikhin” company
12:00-12:15
Break
12:15-14:15
Practical part: “New formats of GMP-inspections: online inspection of the site manufacturing injection forms”
  • Experience in conducting pharmaceutical inspections. Analysis of typical non-conformities
  • Movie-clip about the preparation of a site to be inspected
  • Movie - online inspection of injection forms manufacturing
  • Analysis of situational issues. Answers to questions
  • Voting on identified non-conformities
Moderators:
  • Gelena Grosheva, Head of section for licensing and inspection of drugs manufacturing, Department of Pharmaceutical and Medical Industry Development of the Ministry of Industry and Trade of the Russian Federation
  • Natalia Chadova, Head of Department on Drug Product Inspection and Expert Evaluation, State Institute of Drugs and Good Practices
Invited speakers:
  • 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
  • Olga Maklakova, Quality Director, Akrikhin “Remote inspections: experience and results”
  • Ekaterina Nikiforova, Head of Drug Manufacture Inspections Department, Federal State Institution "State Institute of Drugs and Good Practices
  • Matthias Schniberger, Head of Quality and Compliance Division, Roche company, Movie-clip about online inspections
Closed event
12:15-14:00
Meeting of Russian pharmaceutical manufacturers with Trade missions of the Russian Federation
Parallel event!
Issues to be discussed:
  • Experience of Russian Trade Missions in the framework of export strategy during the pandemic
  • Countries overview and market conditions
  • States’ needs for pharmaceutical products
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
  • Vladislav Shestakov, Director of the State Institute of Drugs and Good Practices
Participants:
  • Nickolai Aslanov, Trade Representative of Russia in Egypt
  • Aleksey Glinskiy, Deputy Trade Representative of Russia in South Africa
  • Sergey Piskunov, consultant at Russia’s Trade Mission in South Africa
  • Galina Kurochkina, Trade Representative of Russia in Spain
  • Petr Pavlenko, Trade Representative of Russia in Japan
  • Alexandra Krasovskaya, consultant at Russia’s Trade Mission in Japan
  • Sergey Rossomakhov, Trade Representative of Russia in Indonesia “Cooperation of Russia and Indonesia in the medical and pharmaceutical industry
  • Makarov Mikhail, Trade Representative of Russia in France
  • Zabyrina Elena, consultant at Russia’s Trade Mission in France
  • Nalich Ivan, Trade Representative of Russia in Algeria
  • Tsygankov Kirill, chief specialist-expert at Russia’s Trade Mission in Vietnam
Pre-registration is required
14:15–14:30
Break
14:30–16:15
Practical part: “New formats of GMP-inspections: undergo the inspection together with the regulator”
  • Online inspection
  • Manufacturer's comments about remote GMP inspections
  • Analysis of situational issues. Answers to questions
Moderator: Natalia Chadova, Head of Department on Drug Product Inspection and Expert Evaluation, State Institute of Drugs and Good Practices
Invited speakers:
  • Irina Krasnokutskaya, Head of the Medical Products Registration Department of Novo Nordisk
  • Vladimir Smirnov, Senior Specialist of Department on Drug Product Inspection, Federal State Institution "State Institute of Drugs and Good Practices
Session’s partner: “Novo Nordisk” company
Roundtable
14:30–16:15
Pecularities of organizing the manufacturing of immunobiologicals: technology, quality control and logistics
Issues to be discussed:
  • Development of manufacturing of immunobiologicals in Russia: current situation and perspectives
  • Cooperation in manufacturing of immunobiologicals
  • Organization and control of “cold chain” for storage and transportation of immunobiological drugs
  • Experience of inspecting the manufacturing of immunobiologicals
  • Examples of cooperation of the Russian and foreign companies in localization of manufacturing of immunobiologicals
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
  • Irina Novikova, General Director, GMP news
Invited speakers:
  • Gelena Grosheva, Head of section for licensing and inspection of drugs manufacturing, Department of Pharmaceutical and Medical Industry Development of the Ministry of Industry and Trade of the Russian Federation
  • Representative of State Institute of Drugs and Good Practices
  • Representative of MSD company
  • Representative of Fort company
  • Representative of NPO Petrovax Pharm
  • Representative of Chumakov Federal Scientific Center for Research and Development
  • of Immune and Biological Products of Russian Academy of Sciences
  • Representative of “St. Petersburg Research Institute of Vaccines and Serums and the Bacterial Preparation Factory” of the Russian Federal Biomedical Agency
  • Representative of Nanolek
  • Representative of the National Association of Infections Control
  • Stanislav Uiba, General Director, MECHNIKOV Institute
With the support of the Conference’s general partner: MSD company
16:15-16:30
Wrapping up and concluding remarks of the Master-class