Всероссийская GMP-конференция | Conference program
Conference program
September, 22, first day
09:00–10:00
Registration of participants
Plenary session
10:00–12:00
Strong regulator – robust industry
Questions and topics for discussion:
  • Structural approach in bringing the Russian industry to an international level
  • Actions of the regulatory authorities during the pandemic.
  • Experience of inter-agency interaction.
  • Analysis of decisions made and their results
  • Experience of foreign drug regulatory authorities
Moderator:
  • Vladislav Shestakov, Director of FSI “SID & GP” of the Russian Ministry of Industry and Trade
Speakers:
  • Representative of the Russian Ministry of Industry and Trade
  • Representative of the Russian Ministry of Health
  • Representative of the Federal Service of Surveillance in Healthcare
  • Representative of the Eurasian Economic Commission
  • Representatives of the Eurasian Economic Union’s regulatory authorities
  • Representatives of the European Union’s regulatory authorities
  • Representative of the Russian Direct Investment Fund
  • Representatives of foreign drug regulators
  • Representatives of pharmaceutical companies and industry associations
12:00–12:20
Break
Panel discussion
12:20–13:50
New elements in regulating drug circulation within the Eurasian Economic Union
Questions and topics for discussion:
  • Pressing issues pertaining to the integration within the single pharmaceutical market of the EAEU
  • Review of current changes in the laws and regulations
  • New level III documents
  • Inspection procedure in accordance with the EAEU rules (as part of the registration procedures and on the request of the national Ministry of Health) and regulators’ experience in conducting inspections of drug manufacturing
  • Issues regarding the maintenance of the EAEU register
  • Pharmacopeia of the Eurasian Economic Union
Moderators:
  • Elena Denisova, Deputy Director of Department of Pharmaceutical and Medical Industry Development, Russian Ministry of Industry and Trade
  • Dmitriy Rozhdestvenskiy, Head of Division for Coordination of Activities in the field of circulation of Drugs and Medical Devices, Technical Regulation and Accreditation Department of the Eurasian Economic Commission
Speakers:
  • Representative of the Russian Ministry of Industry and Trade
  • Representative of FSI “SID & GP” of the Russian Ministry of Industry and Trade
  • Representative of the Russian Ministry of Health
  • Representatives of Eurasian Economic Union’s regulatory authorities
  • Representative of the European Commission
  • Representative of the he Institute of Legislation and Comparative Law under the Government of the Russian Federation
13:50–14:50
Lunch
14:50–16:20
Continuation of panel discussion «New elements in regulating drug circulation within the Eurasian economic union»
16:20–16:40
Lunch
Panel discussion
16:40-18:10
Current developments of the pharmaceutical market: Time and place for systemic expertise
Questions and topics for discussion:
  • The need for enhancing systems of domestic pharmaceutical developments
  • Compliance with GMP rules during the drug’s development phase
  • Technology transfer. Scaling- up of manufacturing.
  • Development of the domestic full manufacturing cycle: objectives, opportunities and perspectives
  • System of state reference standards in Russia
  • Main phases of drug development: active pharmaceutical substance, preclinical studies, clinical studies, registration, manufacturing
Moderator: *Roman Ivanov, Rector of Sirius University of Science and Technology, Educational Foundation «Talent and Success»
Speakers:
  • Representative of the Russian Ministry of Industry and Trade
  • Representative of FSI “SID & GP” of the Russian Ministry of Industry and Trade
  • Representative of LLC “National Centre of Reference Standards”
  • Representatives of industry communities and associations
  • Representatives of the pharmaceutical companies
20:00
Evening event
September? 23, second day
Panel discussion
10:00–11:30
Holistic view pertinent to regulation of GxP practices
  • GLP regulatory issues: laboratories and testing centres
  • New regulatory elements in in GCP
  • Legal and organization issues of GDP regulation
  • Dietary supplements: relevant regulatory issues
Moderators:
  • *Roman Drai, Director of R&D center, Geropharm
  • *Lillia Titova, Executive Director Union of Professional Pharmaceutical Organizations (SPFO)
Speakers:
  • Representative of the Russian Ministry of Industry and Trade
  • Representative of the FSI “SID & GP” of the Russian Ministry of Industry and Trade
  • Representative of the Russian Ministry of Health
  • Representatives of the Eurasian Economic Union member states
  • Representatives of R&D centers
  • Representatives of pharmaceutical companies
  • Representatives of industry associations, including association of the manufacturers of dietary supplements
  • Representatives of distribution companies
11:30-11:50
Break
11:50-13:20
Continuation of panel discussion «Holistic view pertinent to regulation of GxP practices»
Parallel Event!
Panel discussion
11:50-13:20
Inspection of manufacturers of drugs for veterinary use. Regulation and statistics. The view of the state and business
Parallel Event!
  • Regulation of inspection of manufacturers of drugs for veterinary use under EAEU rules
  • Experience of inspecting European manufacturers of veterinary drugs
Moderator: Under consideration
Speakers:
  • Representative of the Federal State Budgetary Institution «The Russian State Center for Animal Feed and Drug Standardization and Quality»
  • Representative of the FSI “SID & GP” of the Russian Ministry of Industry and Trade
  • Representative of the Russian Ministry of Agriculture
  • Representatives of the Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor)
  • Representative of the European Commission
  • Representatives of veterinary drugs manufacturing companies
13:20-14:20
Lunch
Panel discussion
14:20-15:50
Regulatory issues pertinent to export of Russian drugs
Parallel Event!
Questions and topics for discussion:
  • Foreign markets review. Potential and opportunities of Russian pharmaceutical manufacturers for exporting their products
  • Challenges and ways to overcome them in generating export opportunities for Russian companies: issues related to the compliance with international standards and requirements
  • Preparation of the registration dossier
  • Passing foreign GMP inspections. Experience of the leading Russian companies
Moderators:
  • Dmitriy Galkin, Director of Department of Pharmaceutical and Medical Industry Development, Russian Ministry of Industry and Trade
  • Chairman of the Association of Pharmaceutical Manufacturers of the Eurasian Economic Union
Speakers:
  • Representative of the Russian Ministry of Industry and Trade
  • Representative of FSI “SID & GP” of the Russian Ministry of Industry and Trade  
  • Trade representatives of the Russian Federation abroad
  • Representatives of the pharmaceutical companies
  • Representative of the European Union
  • Representatives of the member-states of the Eurasian Economic Union
15:50–16:10
Break
16:10–17:40
Session of the General Sponsor
September, 24, third day
10:00-11:00
Competition “Best Technical Director (Specialist)”. Launch of the voting on a video-clip contest
Master-class
10:00–11:30
«Technology Transfer. Regulatory Requirements». Part 1
Speakers:
  • Representative of FSI “SID & GP” of the Russian Ministry of Industry and Trade
  • Representative of the Russian Ministry of Industry and Trade
11:00-11:20
Break
Master-class
11:20–12:35
«Technology Transfer. Regulatory Requirements». Part 2
Speakers:
  • Representatives of foreign drug regulators
  • Representatives of foreign drug manufacturers
12:35-13:35
Lunch. Termination of the voting on a video-clip contest
Master-class
13:35–15:05
«Technology Transfer. GMP Inspections. Practice of Technology Transfer from the inspector’s point of view»
Speakers:
  • Representatives of FSI “SID & GP” of the Russian Ministry of Industry and Trade
  • Representatives of pharmaceutical companies
13:35–15:05
Summing up voting results of a video-clip contest, award ceremony