Program 2021

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:

• Aleksey Alekhin, Director of the Department for pharmaceutical and medical industry development, Ministry of Industry and Trade of the Russian Federation
• Romanov Filipp, Head of the Department of Government Regulations of Medicines Circulation, Ministry of Health of the Russian Federation
• Kosenko Valentina, Deputy 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”
• Jerome 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”
• Wesal Haqaish, Drug Directorate Director, Jordan Food and Drug Administration (JFDA) “Mitigating the Impact of COVID: Jordanian Pharmaceutical & medical industry Responses as a Promising & Growing sectors”
• Marwan Akar, Managing Director of MSD Pharmaceuticals LLC, Managing Director of MSD in Russia, Belarus and Kazakhstan

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:

• 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 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”
• Lavnik Elena, Head of the Pharmaceutical Inspection Department of the Ministry of Health, Republic of Belarus
• Margarita Mustafina, Quality Director, Russia and Eurasia. Teva
• Stanislav Naumov, Chairman of the Board of the Eurasian Economic Union Association of Pharmaceutical Manufacturers
• Nikolko Tatiana, Deputy Head Pharmaceutical Production Inspection and Expertise Administration, State Institute of Drugs and Good Practices Russian Federation
• 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
• Anatoliy Chernyavskiy, Head of the Good Pharmaceutical Practices Department, Center for Examinations and Tests in Health Service Republican Unitary Enterprise, Republic of Belarus
• Mkrtich Shakaryan, Head of Division for Good Pharmacy Practice, Scientific Center of Drug and Medical Technologies Expertise after academician Emil Gabrielyan, Armenia
• Julia Stekolshchikova, Chief Specialist of the Quality Management Department of Karpov Research Institute of Physical Chemistry (Rosatom)

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 “Development prospects of local manufacturing of a wide range of pharmaceutical substances in the Russian Federation”
• Elena Galkina, Head of Public Relations, Geropharm “Main criteria for forming the government strategy for the development of national substances manufacturing”
• 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”
• Alexander Lakhmotko, Marketing and Business Development Director, Long Sheng Pharma Rus LLC
• Olesya Polyanskaya, Communications Director, The Society of Professional Pharmaceutical Organizations
• 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), Bright Way Group President

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, Ph.D., 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, Deputy director for educational activities of Pharmstrategy LLC, 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
• Olga Podolskaya, Data Culture project manager, National Research University “Higher School of Economics”
• Evgeniy Sokolov, Data Culture project leading expert, National Research University “Higher School of Economics”
• Representative of BIOCAD company

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
• Aleksey Efimov, Acting Trade Representative of Russia in China
• Vadim Dolgopolov, Chief expert of Russian Trade mission in China
• Anton Kruglov, Consultant of Trade mission’s branch in Shanghai
• 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, Trade Representative of Russia in Brazil

Moderator: 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”
• Natalia Popova, Division Director for Quality and Compliance, Abbott Pharmaceuticals Division “Modelling of aseptic process with the use of digest medium”
• 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)”

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”
• Vera Korobova, Head of the group for introducing new medicines at JSC Gedeon Richter-Rus (“Experience in organizing packaging of samples for clinical trials”)
• 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
• Alla Trapkova, 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”
• Igor Shokhin, General Director of “Center of Pharmaceutical Analytics”
• Marla A. Phillips, Director, Xavier Health, Xavier University (USA)
• Representative of Gedeon Richter Rus.

Moderator: Igor Falkovskiy, the Head of the Department for Good Engineering Practice of the State Institute of Drugs and Good Practices

Invited speakers:

• 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”