III Всероссийская GMP-конференция | Сonference program
Сonference program
Attention! This page presents the draft program of the conference. The program will be amended.
August 27, First Day
REGULATORS` DAY
Venue: 1a Ershova Street, Kazan, Russia, Conference center of the The Korston Club Hotel Kazan
8:00–10:30
Registration, welcome coffee
10:30–12:00
OPENING CEREMONY OF THE THIRD ALL-RUSSIAN GMP CONFERENCE
Moderator: Head of the Federal State Institution “State Institute of Drugs and Good Practices” of the Ministry of Industry and Trade of the Russian Federation Vladislav Shestakov
Invited speakers*:
  • President of the Republic of Tatarstan Rustam Minnikhanov
  • Minister of Industry and Trade of the Russian Federation Denis Manturov
  • Minister of Economic Development of the Russian Federation Maksim Oreshkin
  • Minister of Health of the Russian Federation Veronika Skvortsova
  • Head of the Federal Service for Surveillance in Healthcare Mikhail Murashko
  • Head of the Federal Antimonopoly Service of the Russian Federation Igor Artemiev
PLENAR SESSION
12:00–14:00
Drivers of pharmaceutical market growth. Global view
Moderator: Russian journalist and TV anchor, public figure Sergey Brilyov
Themes*:
  • Effective state regulation solutions as the driver of the industry development
  • New opportunities for the pharmaceutical industry: a project-based approach in the Republic of Tatarstan
  • Interministerial interaction as the main instrument for the successful development of the industry
  • The advanced technology in the pharmaceutical industry: investments and results
  • Review of international practices in stimulation of the pharmaceutical market development
Invited speakers*:
  • First Deputy Minister of Industry and Trade of the Russian Federation Sergey Tsyb
  • Minister of Industry of the Republic of Tatarstan Albert Karimov
  • Head of the Department of Drug Supply and Regulation of Medical Devices of the Ministry of Health of the Russian Federation Elena Maksimkina
  • Executive Director of The Association of International Pharmaceutical Manufactures (AIPM) Vladimir Shipkov
14:00–15:00
Lunch
PANEL DISCUSSION
15:00–16:30
Pharmaceutical industry of the Future. View of the state and business
Moderator: Dmitry Sheiman, CEO «Pharmstrategy»
Themes*:
  • The «Pharma-2030» strategy. Pharmaceutical industry perspectives.
  • Formation of the single market strategy as a factor in stimulating of the Russian pharmaceutical market growth. Potential of the future
  • Export potential. Forecasts for the development of the pharmaceutical industry
Invited speakers*:
  • Head of the Department of Pharmaceutical and Medical Industry Development of the Ministry of Industry and Trade of the Russian Federation Alexey Alekhin
  • Director of Research Institute of Health organization under Moscow Department of Health David Melik-Guseinov
  • Rector of the St. Petersburg State Chemical and Pharmaceutical Academy Igor Narkevich
PANEL DISCUSSION
16:30–18:00
Single regulator system. New trends, formats for cooperation
Moderator: Board Chairman of Association of EAEU Pharmaceutical Manufacturers Dmitriy Chagin
Themes*:
  • Approaches to the organization of regulatory systems in Russia and the world
  • Ways of convergence and standardization of regulatory systems by the example of global associations
  • The effectiveness of over national associations by the example of the results of registration of veterinary medicinal products and feed additives. Specifics of GMP-inspections of medicines for animals
  • Concerns of control over the turnover of products potentially hazardous to the health of consumers: dietary supplements and cosmeceuticals
Invited speakers*:
  • Head of the Federal Service for Veterinary and Phytosanitary Surveillance Sergey Dankvert
  • Head of the Federal Service for Supervision of Consumer Rights Protection and Human Welfare – Chief State Sanitary Doctor of the Russian Federation Anna Popova
  • Head of the Department for Control over Social Sphere and Trade of the Federal Antimonopoly Service of the Russian Federation Timofey Nizhegorodtsev
  • CEO of the Association of the Russian Pharmaceutical Manufacturers (ARPM) Victor Dmitriev
  • Rapporteur PIC/S, The French National Agency for Medicines and Health Products Safety (ANSM), Jacques Morenas
18:00–19:00
Dinner
19:00–21:00
PREMIER OF THE FILM ABOUT PHARMACEUTICAL INDUSTRY
August 28, Second Day
INTERNATIONAL DAY
8:30–9:00
Welcome coffee break
9:00–9:30
OPENING OF THE SECOND DAY OF THE CONFERENCE
Moderator: Head of the Federal State Institution «State Institute of Drugs and Good Practices» of the Ministry of Industry and Trade of the Russian Federation Vladislav Shestakov
Themes*:
  • Questions raised on the First day of the Conference.
  • Plan for the second day of the Conference.
PLENAR SESSION
9:30–11:30
Cross-country cooperation in the GMP sphere. Considerations over mutual recognition
Moderator: Head of the Federal State Institution “State Institute of Drugs and Good Practices” of the Ministry of Industry and Trade of the Russian Federation Vladislav Shestakov
Themes*:
  • Specifics of pharmaceutical legislation and GMP regulation in different countries
  • Ways and opportunities for cross-country cooperation
  • International regulations convergence: was it done enough?
  • Opportunities for interaction at the level of labor union organizations and associations
Invited speakers*:
  • Head of WHO Representative Office to the Russian Federation Melita Vujnović
  • Representative of EMA Roberto Conocchia
  • Head of the Inspectorate HALMED (Croatia) Izabela Majic
  • Office Director, Office of Compliance and Standards, PMDA (Japan) Shingou Sakurai
  • Deputy Director of the Inspection, Enforcement and Standards Division and Head of the MHRA Mark Birse
  • Head Global Regulatory Management, Life Science, Quality and Regulatory Management, Merck KGaA, Najib Sehat
  • Vice President, Quality and Regulatory Compliance NovoNordisk, Former Associate Director for Policy and Regulation US FDA Andrew Chang
  • Executive Director Global External Advocacy Merck Mohan Ganapathy
  • Assistant Professor. Director, Regulatory Affairs School of Medicine and Health Sciences – The George Washington University (USA) Daniela Drago
  • Director Quality External Affairs AMGEN Stephan Rönninger
PANEL DISCUSSION
11:30–14:00
National GMP rules of EAEU. New emphasis
Moderator: Board Chairman of Association of EAEU Pharmaceutical Manufacturers Dmitriy Chagin
Themes*:
  • New emphasis in the technical regulation of the EAEU countries in the context of GMP
  • Considerations on functioning of the single market of medicines
  • Rules and procedure for conducting GMP-inspections according to the rules of the EAEU
  • Accession of EAEU member countries to PIC/S: potential, outlook and benefits
  • International cooperation of inspectorates and current inspection standards
Invited speakers*:
  • Deputy Director of the Department of the Development of the Pharmaceutical and Medical Industry of the Ministry of Industry and Trade of the Russian Federation Elena Denisova
  • Head of the Coordination Department in the field of circulation of drugs and medical products of the Department of Technical Regulation and Accreditation of the Eurasian Economic Commission Dmitry Rozhdestvenskiy
  • Acting General Director of the National Center for Drug Expertise, medical devices and medical equipment Ministry of Health and Social Development of the Republic of Kazakhstan Aygul Shoranova
  • Head of Department for Inspection of Medicines and Expertise Natalia Chadova
  • Head of Implementation and Development of Good Pharmaceutical Practices and International Standards Department of the «National Center for Expertise of Medicines, Medical Devices and Medical Equipment» of the Ministry of Health of the Republic of Kazakhstan Elena Stepkina
  • Head of the Department of Pharmaceutical Inspection and Organization of Drug Provision of the Ministry of Health of the Republic of Belarus Lyudmila Reutskaya
  • Head of Inspection Department "Scientific Centre of Drug and Medical Technology Expertise after academician E. Gabrielyan" CJSC (Armenia) Mkrtich Shakaryan
  • Head of Office of Quality Assessment of Medicines and Medical Products of the Department of medicines and medical devices of Ministry of Health of the Kyrgyz Republic Chinara Mambetalieva
14:00–15:00
Lunch
PANEL DISCUSSION
15:00–16:30
International GDP and medicines labeling experience for the development of pharmaceutical industry
Moderator: Executive Director of the Union of Professional Pharmaceutical Organizations Liliya Titova
Themes*:
  • The labeling of medicines in Russia: the current agenda
  • The experience of foreign regulators in implementing traceability of the drug labeling system using the example of the European Medicines Agency (EMA), Turkey, China
  • Readiness of foreign pharmaceutical business to launch marking in Russia
Invited speakers*:
  • Deputy head of the Federal Service for Supervision in the Sphere of Health Care of the Russian Federation Valentina Kosenko
  • Deputy Head of the Department for Inspection of the Manufacture of Medicines and Expertise of the Federal State Institution “State Institute of Drugs and Good Practices” of the Ministry of Industry and Trade of the Russian Federation Tatyana Nikolko
  • Representative of EMA (European Medicines Agency) Roberto Canokkia
  • Deputy Director, Department of International Cooperation, State Food and Drug Administration, PRC, Wang Xiangyu
  • Vice-President of TMMDA, Turkey, Fatih Tan
PANEL DISCUSSION
16:30–18:00
Overview of trends in the field of GEP. Discussion of the ISPE EAEU
Moderator: Director of the Center for Collective Use (Scientific and Educational Center), Head of the Department of Pharmaceutical Technology, Faculty of Advanced Training of Medical Workers of the PFUR Rimma Abramovich
Themes*:
  • Production Transfer
  • Issues of technical regulation and standardization of manuals and rules for the design and organization of production
  • Organization of interaction between professionals in the pharmaceutical industry for the best results
  • Factories of the future
Invited speakers*:
  • Vice President for European Operations, International Society of Pharmaceutical Engineering (ISPE) Thomas Zimmer
  • Head of the Department of Good Engineering Practices of the FSI «SID & GP» Igor Falkovsky
  • Quality Director Abbott Dr.Ulrich Becht
  • Head of the Global Quality Compliance of Solid Forms Novartis Group Achim Lueckel
18:00–18:30
THE FORMAL CLOSE OF THE THIRD ALL-RUSSIAN GMP CONFERENCE
Moderator: Head of the Federal State Institution «State Institute of Drugs and Good Practices» of the Ministry of Industry and Trade of the Russian Federation Vladislav Shestakov
August 29, Third Day
BEST PRACTICES` DAY
8:30–9:00
Welcome coffee break
MASTER CLASSES
10:00–12:00
Master class on GMP-inspection
Organizers: Ministry of Industry and Trade of Russia and FSI «GILS and NP»
10:00–12:00
Master class on Data Integrity
Organizers: FSI «GILS and NP» and PQE
14:00–15:00
Dinner
15:00–16:00
Master class on authorized persons
Organizers: First Moscow State Medical University named after I.M. Sechenov
16:00–17:00
Master-class on technology transfer
Organizers: PFUR
* – Speaker/theme is to be confirmed