Speakers 2021
Kirill Soloveichik
Head of the Committee for Industrial Policy, Innovations and Trade of Saint Petersburg
Kirill Soloveichik
Head of the Committee for Industrial Policy, Innovations and Trade of Saint Petersburg
Participates
Plenary session
Strong regulator – robust industry
Время: 10:00 - 12:00
• 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

Fillip Romanov
Director of Department for State Regulation of Drug Circulation of the Ministry of Health of the Russian Federation

Fillip Romanov
Director of Department for State Regulation of Drug Circulation of the Ministry of Health of the Russian Federation
Participates
Plenary session
Strong regulator – robust industry
Время: 10:00 - 12:00
• 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
Elena Kudryavtseva
Head of the Directorate for Organization of State Control of Medicinal Products, Federal Service for Surveillance in Healthcare
Elena Kudryavtseva
Head of the Directorate for Organization of State Control of Medicinal Products, Federal Service for Surveillance in Healthcare
Participates
Plenary session
Strong regulator – robust industry
Время: 10:00 - 12:00
• 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

Dzhanyl Dzhusupova
Director of the Technical Regulation and Accreditation Department of the Eurasian Economic Commission

Dzhanyl Dzhusupova
Director of the Technical Regulation and Accreditation Department of the Eurasian Economic Commission
Participates
Plenary session
Strong regulator – robust industry
Время: 10:00 - 12:00
• 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
Timurlan Kуsanov
Director of the Department of drugs and medical devices of the Ministry of Health of Republic of Kazakhstan
Timurlan Kуsanov
Director of the Department of drugs and medical devices of the Ministry of Health of Republic of Kazakhstan
Participates
Plenary session
Strong regulator – robust industry
Время: 10:00 - 12:00
• 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

Jérôme Lepeintre
Minister - Counsellor for health and agriculture of the EU Delegation to the Russian Federation

Jérôme Lepeintre
Minister - Counsellor for health and agriculture of the EU Delegation to the Russian Federation
Participates
Plenary session
Strong regulator – robust industry
Время: 10:00 - 12:00
• 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

Michel Sidibé
African Union's Special Envoy for the African Medicines Agency

Michel Sidibé
African Union's Special Envoy for the African Medicines Agency
Participates
Plenary session
Strong regulator – robust industry
Время: 10:00 - 12:00
• 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

Olga Lidia Jacobo Casanueva
Director of Center for State Control of Medicines and Medical Devices (Cuba)

Olga Lidia Jacobo Casanueva
Director of Center for State Control of Medicines and Medical Devices (Cuba)
Participates
Plenary session
Strong regulator – robust industry
Время: 10:00 - 12:00
• 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

Muhammed Mahbubur Rahman
Director General of Directorate General of Drug Administration (Bangladesh)

Muhammed Mahbubur Rahman
Director General of Directorate General of Drug Administration (Bangladesh)
Participates
Plenary session
Strong regulator – robust industry
Время: 10:00 - 12:00
• 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

Leandro Villanueva
General Director of the General Directorate of Medicines, Food and Health Products of Ministry of Public Health of the Dominican Republic

Leandro Villanueva
General Director of the General Directorate of Medicines, Food and Health Products of Ministry of Public Health of the Dominican Republic
Participates
Plenary session
Strong regulator – robust industry
Время: 10:00 - 12:00
• 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
Panel discussion 12:20 – 13:50
Interdisciplinary approach to regulating good practices (GxP)
Время: 12:20 - 13:50
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.
Session partner company - Abbott
Continuation of panel discussion 15:00-16:30
Interdisciplinary approach to regulating good practices (GxP)
Время: 15:00 - 16:30
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.
Neale Baldwin
Senior GMP inspector of Therapeutic Goods Administration (Australia)
Neale Baldwin
Senior GMP inspector of Therapeutic Goods Administration (Australia)
Participates
Plenary session
Strong regulator – robust industry
Время: 10:00 - 12:00
• 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

Kamel Mansouri
General Director of National Agency of Pharmaceutical Products (Algeria)

Kamel Mansouri
General Director of National Agency of Pharmaceutical Products (Algeria)
Participates
Plenary session
Strong regulator – robust industry
Время: 10:00 - 12:00
• 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
Panel discussion 16:50 – 18:20
Current developments of the pharmaceutical market: Time and place for systemic expertise
Время: 16:50 - 18:20
• 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
Session partner company - Akrikhin

Elena Denisova
Deputy Director of Department of Pharmaceutical and Medical Industry Development, Russian Ministry of Industry and Trade

Elena Denisova
Deputy Director of Department of Pharmaceutical and Medical Industry Development, Russian Ministry of Industry and Trade
Participates
Panel discussion 12:20 – 13:50
Interdisciplinary approach to regulating good practices (GxP)
Время: 12:20 - 13:50
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.
Session partner company - Abbott
Continuation of panel discussion 15:00-16:30
Interdisciplinary approach to regulating good practices (GxP)
Время: 15:00 - 16:30
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.
Panel discussion 10:00 – 11:30
Novelties in regulating drug circulation within the Eurasian Economic Unio
Время: 10:00 - 11:30
• 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)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - PRO.MED.CS Praha a.s.
Continuation of panel discussion 11:50
Novelties in regulating drug circulation within the Eurasian Economic Union
Время: 11:50 - 13:30
•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)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - Petrovax Pharm
Panel discussion 14:40 – 16:40
Modern approaches to manufacturing biologicals within the requirements of good practices
Время: 14:40 - 16:40
● Issues relating to the organization of the aseptic manufacturing of biological products
With the support of General partner company - National Immunobiological Company” (Nacimbio)
Master-class
Opening of Master-class “Technology Transfer. Regulatory Requirements”
Время: 10:15 - 12:25
MoreMaysie Vallejos Campos
Head of Good Practices Section, Institute of Public Health (Chile)
Maysie Vallejos Campos
Head of Good Practices Section, Institute of Public Health (Chile)
Participates
Panel discussion 12:20 – 13:50
Interdisciplinary approach to regulating good practices (GxP)
Время: 12:20 - 13:50
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.
Session partner company - Abbott
Continuation of panel discussion 15:00-16:30
Interdisciplinary approach to regulating good practices (GxP)
Время: 15:00 - 16:30
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.

Ferenc Lukács
Inspectorate Head of National Institute of Pharmacy and Nutrition (OGYÉI), Hungary

Ferenc Lukács
Inspectorate Head of National Institute of Pharmacy and Nutrition (OGYÉI), Hungary
Participates
Panel discussion 12:20 – 13:50
Interdisciplinary approach to regulating good practices (GxP)
Время: 12:20 - 13:50
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.
Session partner company - Abbott
Continuation of panel discussion 15:00-16:30
Interdisciplinary approach to regulating good practices (GxP)
Время: 15:00 - 16:30
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.
Master-class
Opening of Master-class “Technology Transfer. Regulatory Requirements”
Время: 10:15 - 12:25
MoreIgor Shokhin
General Director, Center of Pharmaceutical Analytics
Igor Shokhin
General Director, Center of Pharmaceutical Analytics
Participates
Panel discussion 12:20 – 13:50
Interdisciplinary approach to regulating good practices (GxP)
Время: 12:20 - 13:50
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.
Session partner company - Abbott
Continuation of panel discussion 15:00-16:30
Interdisciplinary approach to regulating good practices (GxP)
Время: 15:00 - 16:30
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.

Dmitry Ivkin
Head of Center of experimental pharmacology, Saint-Petersburg State Chemical Pharmaceutical Academy

Dmitry Ivkin
Head of Center of experimental pharmacology, Saint-Petersburg State Chemical Pharmaceutical Academy
Participates
Panel discussion 12:20 – 13:50
Interdisciplinary approach to regulating good practices (GxP)
Время: 12:20 - 13:50
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.
Session partner company - Abbott
Continuation of panel discussion 15:00-16:30
Interdisciplinary approach to regulating good practices (GxP)
Время: 15:00 - 16:30
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.

Elena Shipaeva
Head of Non-clinical Group of Non-clinical trials and clinical trials of Medical Department, R-Pharm

Elena Shipaeva
Head of Non-clinical Group of Non-clinical trials and clinical trials of Medical Department, R-Pharm
Participates
Panel discussion 12:20 – 13:50
Interdisciplinary approach to regulating good practices (GxP)
Время: 12:20 - 13:50
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.
Session partner company - Abbott
Continuation of panel discussion 15:00-16:30
Interdisciplinary approach to regulating good practices (GxP)
Время: 15:00 - 16:30
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.
Arina Selezneva
Deputy Head of Section for Good Practices (GLP focus), State Institute of Drugs and. Good Practices
Arina Selezneva
Deputy Head of Section for Good Practices (GLP focus), State Institute of Drugs and. Good Practices
Participates
Panel discussion 12:20 – 13:50
Interdisciplinary approach to regulating good practices (GxP)
Время: 12:20 - 13:50
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.
Session partner company - Abbott
Continuation of panel discussion 15:00-16:30
Interdisciplinary approach to regulating good practices (GxP)
Время: 15:00 - 16:30
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.

Kazei Vasily
General Director, Exakte Labs LLC

Kazei Vasily
General Director, Exakte Labs LLC
Participates
Panel discussion 12:20 – 13:50
Interdisciplinary approach to regulating good practices (GxP)
Время: 12:20 - 13:50
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.
Session partner company - Abbott
Continuation of panel discussion 15:00-16:30
Interdisciplinary approach to regulating good practices (GxP)
Время: 15:00 - 16:30
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.

Daria Varvarina
Tymlat factory, Vladivostok

Daria Varvarina
Tymlat factory, Vladivostok
Participates
Panel discussion 12:20 – 13:50
Interdisciplinary approach to regulating good practices (GxP)
Время: 12:20 - 13:50
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.
Session partner company - Abbott
Continuation of panel discussion 15:00-16:30
Interdisciplinary approach to regulating good practices (GxP)
Время: 15:00 - 16:30
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.
Elena Mukovina
Quality Director, Evalar
Elena Mukovina
Quality Director, Evalar
Participates
Panel discussion 12:20 – 13:50
Interdisciplinary approach to regulating good practices (GxP)
Время: 12:20 - 13:50
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.
Session partner company - Abbott
Continuation of panel discussion 15:00-16:30
Interdisciplinary approach to regulating good practices (GxP)
Время: 15:00 - 16:30
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.

Rubina Bose
Deputy Drugs Controller, Central Drugs Standard Control Organisation (India)

Rubina Bose
Deputy Drugs Controller, Central Drugs Standard Control Organisation (India)
Participates
Panel discussion 12:20 – 13:50
Interdisciplinary approach to regulating good practices (GxP)
Время: 12:20 - 13:50
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.
Session partner company - Abbott
Continuation of panel discussion 15:00-16:30
Interdisciplinary approach to regulating good practices (GxP)
Время: 15:00 - 16:30
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.

Stephan Rönninger
Director for Quality and External Affairs, Amgen (Switzerland)

Stephan Rönninger
Director for Quality and External Affairs, Amgen (Switzerland)
Participates
Panel discussion 12:20 – 13:50
Interdisciplinary approach to regulating good practices (GxP)
Время: 12:20 - 13:50
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.
Session partner company - Abbott
Continuation of panel discussion 15:00-16:30
Interdisciplinary approach to regulating good practices (GxP)
Время: 15:00 - 16:30
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.

Veronika Galyamova
Executive Director, Katren JSC

Veronika Galyamova
Executive Director, Katren JSC
Participates
Panel discussion 12:20 – 13:50
Interdisciplinary approach to regulating good practices (GxP)
Время: 12:20 - 13:50
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.
Session partner company - Abbott
Continuation of panel discussion 15:00-16:30
Interdisciplinary approach to regulating good practices (GxP)
Время: 15:00 - 16:30
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.

Margarita Mustafina
Head of Project Management, TEVA

Margarita Mustafina
Head of Project Management, TEVA
Participates
Panel discussion 12:20 – 13:50
Interdisciplinary approach to regulating good practices (GxP)
Время: 12:20 - 13:50
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.
Session partner company - Abbott
Continuation of panel discussion 15:00-16:30
Interdisciplinary approach to regulating good practices (GxP)
Время: 15:00 - 16:30
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.

Olga Spiridonova
GDP inspector of the Inspectorate Department, “SID & GP” of the Russian Ministry of Industry and Trade

Olga Spiridonova
GDP inspector of the Inspectorate Department, “SID & GP” of the Russian Ministry of Industry and Trade
Participates
Panel discussion 12:20 – 13:50
Interdisciplinary approach to regulating good practices (GxP)
Время: 12:20 - 13:50
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.
Session partner company - Abbott
Continuation of panel discussion 15:00-16:30
Interdisciplinary approach to regulating good practices (GxP)
Время: 15:00 - 16:30
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.

Andres Vinicio de la Torre Conrado
Director of Sanitary Registries, Mandatory Sanitary Notification and Authorizations, National Agency for Health Regulation, Control and Surveillance (Ecuador)

Andres Vinicio de la Torre Conrado
Director of Sanitary Registries, Mandatory Sanitary Notification and Authorizations, National Agency for Health Regulation, Control and Surveillance (Ecuador)
Participates
Panel discussion 12:20 – 13:50
Interdisciplinary approach to regulating good practices (GxP)
Время: 12:20 - 13:50
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.
Session partner company - Abbott
Continuation of panel discussion 15:00-16:30
Interdisciplinary approach to regulating good practices (GxP)
Время: 15:00 - 16:30
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.
Vyacheslav Goryachkin
Head of Section for Good Practices, “SID & GP” of the Russian Ministry of Industry and Trade
Vyacheslav Goryachkin
Head of Section for Good Practices, “SID & GP” of the Russian Ministry of Industry and Trade
Participates
Panel discussion 12:20 – 13:50
Interdisciplinary approach to regulating good practices (GxP)
Время: 12:20 - 13:50
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.
Session partner company - Abbott
Continuation of panel discussion 15:00-16:30
Interdisciplinary approach to regulating good practices (GxP)
Время: 15:00 - 16:30
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.
Panel discussion 14:40 – 16:40
Modern approaches to manufacturing biologicals within the requirements of good practices
Время: 14:40 - 16:40
● Issues relating to the organization of the aseptic manufacturing of biological products
With the support of General partner company - National Immunobiological Company” (Nacimbio)
Razia Solodova
Head of the Department for Economy and Analysis, “SID & GP” of the Russian Ministry of Industry and Trade
Razia Solodova
Head of the Department for Economy and Analysis, “SID & GP” of the Russian Ministry of Industry and Trade
Participates
Panel discussion 16:50 – 18:20
Current developments of the pharmaceutical market: Time and place for systemic expertise
Время: 16:50 - 18:20
• 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
Session partner company - Akrikhin

Vladimir Gegechkori
Deputy General Director for Manufacturing and Strategic Development, “National Centre of Reference Standards”

Vladimir Gegechkori
Deputy General Director for Manufacturing and Strategic Development, “National Centre of Reference Standards”
Participates
Panel discussion 16:50 – 18:20
Current developments of the pharmaceutical market: Time and place for systemic expertise
Время: 16:50 - 18:20
• 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
Session partner company - Akrikhin
Dmitry Somov
Acting General Director of "Information Center for Expertise, Accounting and Analysis of Circulation of Medical Products" of Federal Service for Surveillance in Healthcare
Dmitry Somov
Acting General Director of "Information Center for Expertise, Accounting and Analysis of Circulation of Medical Products" of Federal Service for Surveillance in Healthcare
Participates
Panel discussion 16:50 – 18:20
Current developments of the pharmaceutical market: Time and place for systemic expertise
Время: 16:50 - 18:20
• 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
Session partner company - Akrikhin
Jesus Herrera
Coordinator of Psychotropic Medicines, the Healthcare Autonomous Control Service (Venezuela)
Jesus Herrera
Coordinator of Psychotropic Medicines, the Healthcare Autonomous Control Service (Venezuela)
Participates
Panel discussion 16:50 – 18:20
Current developments of the pharmaceutical market: Time and place for systemic expertise
Время: 16:50 - 18:20
• 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
Session partner company - Akrikhin

Thomas Kirchlechner
Director for Regulatory Policy and Information, Novartis

Thomas Kirchlechner
Director for Regulatory Policy and Information, Novartis
Participates
Panel discussion 16:50 – 18:20
Current developments of the pharmaceutical market: Time and place for systemic expertise
Время: 16:50 - 18:20
• 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
Session partner company - Akrikhin
Madina Sottaeva
Deputy Head of the Department for Drugs Inspection and Expertise, “SID & GP” of the Russian Ministry of Industry and Trade
Madina Sottaeva
Deputy Head of the Department for Drugs Inspection and Expertise, “SID & GP” of the Russian Ministry of Industry and Trade
Participates
Panel discussion 10:00 – 11:30
Novelties in regulating drug circulation within the Eurasian Economic Unio
Время: 10:00 - 11:30
• 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)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - PRO.MED.CS Praha a.s.
Continuation of panel discussion 11:50
Novelties in regulating drug circulation within the Eurasian Economic Union
Время: 11:50 - 13:30
•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)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - Petrovax Pharm
Mariya Ponomareva
Head of Section for Pharmaceutical Inspections, Ministry of Health of the Republic of Belarus
Mariya Ponomareva
Head of Section for Pharmaceutical Inspections, Ministry of Health of the Republic of Belarus
Participates
Panel discussion 10:00 – 11:30
Novelties in regulating drug circulation within the Eurasian Economic Unio
Время: 10:00 - 11:30
• 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)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - PRO.MED.CS Praha a.s.
Continuation of panel discussion 11:50
Novelties in regulating drug circulation within the Eurasian Economic Union
Время: 11:50 - 13:30
•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)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - Petrovax Pharm

Tatiana Tumelya
Head of the Department for Good Pharmaceutical Practice of Republican Unitary Enterprise “Center for Expertise and Testing in Healthcare”, Ministry of Health of the Republic of Belarus

Tatiana Tumelya
Head of the Department for Good Pharmaceutical Practice of Republican Unitary Enterprise “Center for Expertise and Testing in Healthcare”, Ministry of Health of the Republic of Belarus
Participates
Panel discussion 10:00 – 11:30
Novelties in regulating drug circulation within the Eurasian Economic Unio
Время: 10:00 - 11:30
• 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)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - PRO.MED.CS Praha a.s.
Continuation of panel discussion 11:50
Novelties in regulating drug circulation within the Eurasian Economic Union
Время: 11:50 - 13:30
•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)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - Petrovax Pharm
Ardak Tulegenova
Head of Department for Pharmaceutical Expertise of Drugs of the National Center for Expertise of Drugs, Medical Devices and Medical Technologies, Ministry of Health and Social Development of the Republic of Kazakhstan
Ardak Tulegenova
Head of Department for Pharmaceutical Expertise of Drugs of the National Center for Expertise of Drugs, Medical Devices and Medical Technologies, Ministry of Health and Social Development of the Republic of Kazakhstan
Participates
Panel discussion 10:00 – 11:30
Novelties in regulating drug circulation within the Eurasian Economic Unio
Время: 10:00 - 11:30
• 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)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - PRO.MED.CS Praha a.s.
Continuation of panel discussion 11:50
Novelties in regulating drug circulation within the Eurasian Economic Union
Время: 11:50 - 13:30
•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)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - Petrovax Pharm
Aijamal Batralieva
Deputy Director, National Center for Expertise of Medicines and Medical Devices
Aijamal Batralieva
Deputy Director, National Center for Expertise of Medicines and Medical Devices
Participates
Panel discussion 10:00 – 11:30
Novelties in regulating drug circulation within the Eurasian Economic Unio
Время: 10:00 - 11:30
• 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)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - PRO.MED.CS Praha a.s.
Continuation of panel discussion 11:50
Novelties in regulating drug circulation within the Eurasian Economic Union
Время: 11:50 - 13:30
•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)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - Petrovax Pharm
Nazi Abdyrasulova
Head of the Division of Good Pharmaceutical Practice of Department for Drugs and Medical Devices, Ministry of Health of the Kyrgyz Republic
Nazi Abdyrasulova
Head of the Division of Good Pharmaceutical Practice of Department for Drugs and Medical Devices, Ministry of Health of the Kyrgyz Republic
Participates
Panel discussion 10:00 – 11:30
Novelties in regulating drug circulation within the Eurasian Economic Unio
Время: 10:00 - 11:30
• 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)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - PRO.MED.CS Praha a.s.
Continuation of panel discussion 11:50
Novelties in regulating drug circulation within the Eurasian Economic Union
Время: 11:50 - 13:30
•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)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - Petrovax Pharm
Mkrtich Shakaryan
Head of Section for Good Pharmacy Practice, Scientific Center for Drug and Medical Technology Expertise after Academician Emil Gabrielyan
Mkrtich Shakaryan
Head of Section for Good Pharmacy Practice, Scientific Center for Drug and Medical Technology Expertise after Academician Emil Gabrielyan
Participates
Panel discussion 10:00 – 11:30
Novelties in regulating drug circulation within the Eurasian Economic Unio
Время: 10:00 - 11:30
• 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)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - PRO.MED.CS Praha a.s.
Continuation of panel discussion 11:50
Novelties in regulating drug circulation within the Eurasian Economic Union
Время: 11:50 - 13:30
•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)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - Petrovax Pharm
Panel discussion 14:40 – 16:40
Modern approaches to manufacturing biologicals within the requirements of good practices
Время: 14:40 - 16:40
● Issues relating to the organization of the aseptic manufacturing of biological products
With the support of General partner company - National Immunobiological Company” (Nacimbio)
Tatevik Eritsyan
Coordinator for drugs and medical devices circulation within the Eurasian Economic Union, Scientific Center for Drug and Medical Technology Expertise after Academician Emil Gabrielyan
Tatevik Eritsyan
Coordinator for drugs and medical devices circulation within the Eurasian Economic Union, Scientific Center for Drug and Medical Technology Expertise after Academician Emil Gabrielyan
Participates
Panel discussion 10:00 – 11:30
Novelties in regulating drug circulation within the Eurasian Economic Unio
Время: 10:00 - 11:30
• 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)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - PRO.MED.CS Praha a.s.
Continuation of panel discussion 11:50
Novelties in regulating drug circulation within the Eurasian Economic Union
Время: 11:50 - 13:30
•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)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - Petrovax Pharm

Natalia Volovich
Deputy director, Head of Registration department at Gedeon Richter Moscow

Natalia Volovich
Deputy director, Head of Registration department at Gedeon Richter Moscow
Participates
Panel discussion 10:00 – 11:30
Novelties in regulating drug circulation within the Eurasian Economic Unio
Время: 10:00 - 11:30
• 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)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - PRO.MED.CS Praha a.s.
Continuation of panel discussion 11:50
Novelties in regulating drug circulation within the Eurasian Economic Union
Время: 11:50 - 13:30
•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)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - Petrovax Pharm
Anna Kravchuk
Deputy Director, Division for the Coordination of the Circulation of Medicines and Medical Devices, Department of Technical Regulation and Accreditation, Eurasian Economic Commission
Anna Kravchuk
Deputy Director, Division for the Coordination of the Circulation of Medicines and Medical Devices, Department of Technical Regulation and Accreditation, Eurasian Economic Commission
Participates
Panel discussion 10:00 – 11:30
Novelties in regulating drug circulation within the Eurasian Economic Unio
Время: 10:00 - 11:30
• 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)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - PRO.MED.CS Praha a.s.
Continuation of panel discussion 11:50
Novelties in regulating drug circulation within the Eurasian Economic Union
Время: 11:50 - 13:30
•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)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - Petrovax Pharm
Natalia Putilo
Head of Section for Social Legislation, Representative of the he Institute of Legislation and Comparative Law under the Government of the Russian Federation
Natalia Putilo
Head of Section for Social Legislation, Representative of the he Institute of Legislation and Comparative Law under the Government of the Russian Federation
Participates
Panel discussion 10:00 – 11:30
Novelties in regulating drug circulation within the Eurasian Economic Unio
Время: 10:00 - 11:30
• 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)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - PRO.MED.CS Praha a.s.
Continuation of panel discussion 11:50
Novelties in regulating drug circulation within the Eurasian Economic Union
Время: 11:50 - 13:30
•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)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - Petrovax Pharm
Olesya Funtasheva
Roche-Moscow
Olesya Funtasheva
Roche-Moscow
Participates
Panel discussion 10:00 – 11:30
Novelties in regulating drug circulation within the Eurasian Economic Unio
Время: 10:00 - 11:30
• 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)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - PRO.MED.CS Praha a.s.
Continuation of panel discussion 11:50
Novelties in regulating drug circulation within the Eurasian Economic Union
Время: 11:50 - 13:30
•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)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - Petrovax Pharm
Oleg Yarosh
Head of the Department for Organization of State Supervision in the Sphere of Medicines for Veterinary Use, Rosselkhoznadzor
Oleg Yarosh
Head of the Department for Organization of State Supervision in the Sphere of Medicines for Veterinary Use, Rosselkhoznadzor
Participates
Panel discussion 11:50 – 13:20
Inspection of manufacturers of drugs for veterinary use. Regulation and statistics. The view of the state and business
Время: 11:50 - 13:20
• Regulation of inspection of manufacturers of drugs for veterinary use under EAEU rules
• Experience of inspecting European manufacturers of veterinary drugs
Session partner: Avpharm

Danil Rudnyaev
Deputy Director, Head of the Inspection Body, the Russian State Center for Animal Feed and Drug Standardization and Quality

Danil Rudnyaev
Deputy Director, Head of the Inspection Body, the Russian State Center for Animal Feed and Drug Standardization and Quality
Participates
Panel discussion 11:50 – 13:20
Inspection of manufacturers of drugs for veterinary use. Regulation and statistics. The view of the state and business
Время: 11:50 - 13:20
• Regulation of inspection of manufacturers of drugs for veterinary use under EAEU rules
• Experience of inspecting European manufacturers of veterinary drugs
Session partner: Avpharm
Yuri Yeremin
Head of Section for Inspection of Manufacturing Sites For the Conformity of Good Manufacturing Practice, the Russian State Center for Animal Feed and Drug Standardization and Quality
Yuri Yeremin
Head of Section for Inspection of Manufacturing Sites For the Conformity of Good Manufacturing Practice, the Russian State Center for Animal Feed and Drug Standardization and Quality
Participates
Panel discussion 11:50 – 13:20
Inspection of manufacturers of drugs for veterinary use. Regulation and statistics. The view of the state and business
Время: 11:50 - 13:20
• Regulation of inspection of manufacturers of drugs for veterinary use under EAEU rules
• Experience of inspecting European manufacturers of veterinary drugs
Session partner: Avpharm
Sergey Yarunin
Director for Government Relations, AVPHARM
Sergey Yarunin
Director for Government Relations, AVPHARM
Participates
Panel discussion 11:50 – 13:20
Inspection of manufacturers of drugs for veterinary use. Regulation and statistics. The view of the state and business
Время: 11:50 - 13:20
• Regulation of inspection of manufacturers of drugs for veterinary use under EAEU rules
• Experience of inspecting European manufacturers of veterinary drugs
Session partner: Avpharm
Andrey Mezhonov
Executive Director of the AVPHARM Association
Andrey Mezhonov
Executive Director of the AVPHARM Association
Participates
Panel discussion 11:50 – 13:20
Inspection of manufacturers of drugs for veterinary use. Regulation and statistics. The view of the state and business
Время: 11:50 - 13:20
• Regulation of inspection of manufacturers of drugs for veterinary use under EAEU rules
• Experience of inspecting European manufacturers of veterinary drugs
Session partner: Avpharm
Nina Malash
Head of Section for Methodical Provision, State Veterinary Sector of the Republic of Belarus
Nina Malash
Head of Section for Methodical Provision, State Veterinary Sector of the Republic of Belarus
Participates
Panel discussion 11:50 – 13:20
Inspection of manufacturers of drugs for veterinary use. Regulation and statistics. The view of the state and business
Время: 11:50 - 13:20
• Regulation of inspection of manufacturers of drugs for veterinary use under EAEU rules
• Experience of inspecting European manufacturers of veterinary drugs
Session partner: Avpharm
Marie -Agnes Amos
Doctor of Veterinary Science, Deputy Adviser for Agriculture, Assistant for Veterinary, Sanitary, Phytosanitary Issues for Russia, Kazakhstan, Belarus, Armenia, Uzbekistan, Kyrgyzstan, Economic Service of the Embassies of France and Russia
Marie -Agnes Amos
Doctor of Veterinary Science, Deputy Adviser for Agriculture, Assistant for Veterinary, Sanitary, Phytosanitary Issues for Russia, Kazakhstan, Belarus, Armenia, Uzbekistan, Kyrgyzstan, Economic Service of the Embassies of France and Russia
Participates
Panel discussion 11:50 – 13:20
Inspection of manufacturers of drugs for veterinary use. Regulation and statistics. The view of the state and business
Время: 11:50 - 13:20
• Regulation of inspection of manufacturers of drugs for veterinary use under EAEU rules
• Experience of inspecting European manufacturers of veterinary drugs
Session partner: Avpharm
Erik De Ridder
Chair of Regulatory Strategy Team, Health for Animals Association
Erik De Ridder
Chair of Regulatory Strategy Team, Health for Animals Association
Participates
Panel discussion 11:50 – 13:20
Inspection of manufacturers of drugs for veterinary use. Regulation and statistics. The view of the state and business
Время: 11:50 - 13:20
• Regulation of inspection of manufacturers of drugs for veterinary use under EAEU rules
• Experience of inspecting European manufacturers of veterinary drugs
Session partner: Avpharm

Alla Mikhailova
Quality Director of Scientific and Production Association for Immunological Preparations “Microgen”

Alla Mikhailova
Quality Director of Scientific and Production Association for Immunological Preparations “Microgen”
Participates
Panel discussion 14:40 – 16:40
Modern approaches to manufacturing biologicals within the requirements of good practices
Время: 14:40 - 16:40
● Issues relating to the organization of the aseptic manufacturing of biological products
With the support of General partner company - National Immunobiological Company” (Nacimbio)

Patricia Aprea
Director of Evaluation and Control of Biologicals and Radiopharmaceuticals), National Administration of Drugs, Foods and Medical Devices (ANMAT) /National Institution of Drugs (INAME)

Patricia Aprea
Director of Evaluation and Control of Biologicals and Radiopharmaceuticals), National Administration of Drugs, Foods and Medical Devices (ANMAT) /National Institution of Drugs (INAME)
Participates
Panel discussion 14:40 – 16:40
Modern approaches to manufacturing biologicals within the requirements of good practices
Время: 14:40 - 16:40
● Issues relating to the organization of the aseptic manufacturing of biological products
With the support of General partner company - National Immunobiological Company” (Nacimbio)
Master-class
Opening of Master-class “Technology Transfer. Regulatory Requirements”
Время: 10:15 - 12:25
MoreValery Smirnov
Head of Laboratory for Clinical Pharmacology, National Research Center Institute of Immunology of Federal Medical-Biological Agency of Russia
Valery Smirnov
Head of Laboratory for Clinical Pharmacology, National Research Center Institute of Immunology of Federal Medical-Biological Agency of Russia
Participates
Panel discussion 14:40 – 16:40
Modern approaches to manufacturing biologicals within the requirements of good practices
Время: 14:40 - 16:40
● Issues relating to the organization of the aseptic manufacturing of biological products
With the support of General partner company - National Immunobiological Company” (Nacimbio)
Elena Sakanyan
Director for Science, “Scientific and Production Association for Immunological Preparations “Microgen”
Elena Sakanyan
Director for Science, “Scientific and Production Association for Immunological Preparations “Microgen”
Participates
Panel discussion 14:40 – 16:40
Modern approaches to manufacturing biologicals within the requirements of good practices
Время: 14:40 - 16:40
● Issues relating to the organization of the aseptic manufacturing of biological products
With the support of General partner company - National Immunobiological Company” (Nacimbio)

Ekaterina Nikifirova
Deputy Head of the Department for Drugs Inspection and Expertise, “SID & GP” of the Russian Ministry of Industry and Trade

Ekaterina Nikifirova
Deputy Head of the Department for Drugs Inspection and Expertise, “SID & GP” of the Russian Ministry of Industry and Trade
Participates
Panel discussion 14:40 – 16:40
Modern approaches to manufacturing biologicals within the requirements of good practices
Время: 14:40 - 16:40
● Issues relating to the organization of the aseptic manufacturing of biological products
With the support of General partner company - National Immunobiological Company” (Nacimbio)
Master-class
Opening of Master-class “Technology Transfer. Regulatory Requirements”
Время: 10:15 - 12:25
More
Nadezhda Arkhipova
Deputy Head of Section for Expertise, “SID & GP” of the Russian Ministry of Industry and Trade

Nadezhda Arkhipova
Deputy Head of Section for Expertise, “SID & GP” of the Russian Ministry of Industry and Trade
Participates
Panel discussion 14:40 – 16:40
Modern approaches to manufacturing biologicals within the requirements of good practices
Время: 14:40 - 16:40
● Issues relating to the organization of the aseptic manufacturing of biological products
With the support of General partner company - National Immunobiological Company” (Nacimbio)
Tatiana Zagumennikova
Leading specialist, “SID & GP” of the Russian Ministry of Industry and Trade
Tatiana Zagumennikova
Leading specialist, “SID & GP” of the Russian Ministry of Industry and Trade
Participates
Panel discussion 14:40 – 16:40
Modern approaches to manufacturing biologicals within the requirements of good practices
Время: 14:40 - 16:40
● Issues relating to the organization of the aseptic manufacturing of biological products
With the support of General partner company - National Immunobiological Company” (Nacimbio)

Vladimir Smirnov
Chief Expert of Section for Inpection of Drug

Vladimir Smirnov
Chief Expert of Section for Inpection of Drug
Participates
Panel discussion 14:40 – 16:40
Modern approaches to manufacturing biologicals within the requirements of good practices
Время: 14:40 - 16:40
● Issues relating to the organization of the aseptic manufacturing of biological products
With the support of General partner company - National Immunobiological Company” (Nacimbio)
Natalia Burlakina
Leading Specialist of the Section for Drug Manufacturing Sites. “SID & GP” of the Russian Ministry of Industry and Trade
Natalia Burlakina
Leading Specialist of the Section for Drug Manufacturing Sites. “SID & GP” of the Russian Ministry of Industry and Trade
Participates
Master-class
Opening of Master-class “Technology Transfer. Regulatory Requirements”
Время: 10:15 - 12:25
MoreLisette Pérez Ojeda
Advisor to CECMED´s Director
Lisette Pérez Ojeda
Advisor to CECMED´s Director
Participates
Master-class
Opening of Master-class “Technology Transfer. Regulatory Requirements”
Время: 10:15 - 12:25
MoreSuzana Jukić
Senior GMP Inspector of Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
Suzana Jukić
Senior GMP Inspector of Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
Participates
Master-class
Opening of Master-class “Technology Transfer. Regulatory Requirements”
Время: 10:15 - 12:25
More
Cao Yi
Center for Food and Drug Inspection of National Medical Products Administration (People's Republic of China

Cao Yi
Center for Food and Drug Inspection of National Medical Products Administration (People's Republic of China
Participates
Master-class
Opening of Master-class “Technology Transfer. Regulatory Requirements”
Время: 10:15 - 12:25
More
Vera Korobova
Head of Group for Introducing New Products, Gedeon Richter

Vera Korobova
Head of Group for Introducing New Products, Gedeon Richter
Participates
Master-class
Opening of Master-class “Technology Transfer. Regulatory Requirements”
Время: 10:15 - 12:25
MoreTimur Nazarov
Chief technologist, Mechnikov Scientific Research Institute of Vaccines and Serums
Timur Nazarov
Chief technologist, Mechnikov Scientific Research Institute of Vaccines and Serums
Participates
Master-class
Opening of Master-class “Technology Transfer. Regulatory Requirements”
Время: 10:15 - 12:25
MoreMikhail Meshalkin
Senior Specialist of the Support Group for Manufacturing and Transfer, Takeda
Mikhail Meshalkin
Senior Specialist of the Support Group for Manufacturing and Transfer, Takeda
Participates
Master-class
Opening of Master-class “Technology Transfer. Regulatory Requirements”
Время: 10:15 - 12:25
More
Nguyen Ly
Executive Director, Biologics Technical Product Leadership, MSD Pharmaceuticals

Nguyen Ly
Executive Director, Biologics Technical Product Leadership, MSD Pharmaceuticals
Participates
Master-class
Opening of Master-class “Technology Transfer. Regulatory Requirements”
Время: 10:15 - 12:25
MoreMarina Mishustina
Project manager, Novo Nordisk
Marina Mishustina
Project manager, Novo Nordisk
Participates
Master-class
Opening of Master-class “Technology Transfer. Regulatory Requirements”
Время: 10:15 - 12:25
MoreTina Norup
Project manager, Novo Nordisk
Tina Norup
Project manager, Novo Nordisk
Participates
Master-class
Opening of Master-class “Technology Transfer. Regulatory Requirements”
Время: 10:15 - 12:25
More
Olga Maklakova
Corporate Quality Director, Binnopharm

Olga Maklakova
Corporate Quality Director, Binnopharm
Participates
Master-class
Opening of Master-class “Technology Transfer. Regulatory Requirements”
Время: 10:15 - 12:25
More
Vladislav Shestakov
Director of “SID & GP” of the Russian Ministry of Industry and Trade

Vladislav Shestakov
Director of “SID & GP” of the Russian Ministry of Industry and Trade
- Honorary Chemist of the Russian Federation
- Letter of Appreciation ‘For Professional Excellence’ signed by the Russian Minister of Industry and Trade
- Letter of Appreciation signed by the Deputy Health Minister of the Syrian Arab Republic "For Meritorious Contribution to Cooperation between Russia and Syria"
Participates
Plenary session
Strong regulator – robust industry
Время: 10:00 - 12:00
• 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

Dmitry Galkin
Director of Department for Pharmaceutical and Medical Industry Development, Russian Ministry of Industry and Trade

Dmitry Galkin
Director of Department for Pharmaceutical and Medical Industry Development, Russian Ministry of Industry and Trade
Participates
Plenary session
Strong regulator – robust industry
Время: 10:00 - 12:00
• 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

Roman Drai
Director of R&D center, Geropharm

Roman Drai
Director of R&D center, Geropharm
Participates
Panel discussion 12:20 – 13:50
Interdisciplinary approach to regulating good practices (GxP)
Время: 12:20 - 13:50
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.
Session partner company - Abbott
Continuation of panel discussion 15:00-16:30
Interdisciplinary approach to regulating good practices (GxP)
Время: 15:00 - 16:30
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.

Lilia Titova
Executive Director Union of Professional Pharmaceutical Organizations (SPFO)

Lilia Titova
Executive Director Union of Professional Pharmaceutical Organizations (SPFO)
Participates
Panel discussion 12:20 – 13:50
Interdisciplinary approach to regulating good practices (GxP)
Время: 12:20 - 13:50
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.
Session partner company - Abbott
Continuation of panel discussion 15:00-16:30
Interdisciplinary approach to regulating good practices (GxP)
Время: 15:00 - 16:30
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.

Roman Ivanov
Rector of Sirius University of Science and Technology, Educational Foundation “Talent and Success”

Roman Ivanov
Rector of Sirius University of Science and Technology, Educational Foundation “Talent and Success”
Participates
Panel discussion 16:50 – 18:20
Current developments of the pharmaceutical market: Time and place for systemic expertise
Время: 16:50 - 18:20
• 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
Session partner company - Akrikhin

Dmitry Rozhdestvenskiy
Head of Division for Coordination of Activities in the field of circulation of Drugs and Medical Devices, Technical Regulation and Accreditation Department, the Eurasian Economic Commission

Dmitry Rozhdestvenskiy
Head of Division for Coordination of Activities in the field of circulation of Drugs and Medical Devices, Technical Regulation and Accreditation Department, the Eurasian Economic Commission
- In 1998 he graduated from the «Vitebsk state medical Institute».< / li>
- 1999-2002 – post-Graduate studies, then clinical studies in Vitebsk state medical University on a speciality «Clinical pharmacology».
- 2002-2004-Department of General and clinical pharmacology of Vitebsk state medical University (Republic of Belarus).
- 2004-2014-Republican clinical and pharmacological laboratory of up «Center of examinations and tests in health care» (Republic of Belarus).
- 2014-present Eurasian economic Commission, Department of technical regulation and accreditation (Russian Federation).
Participates
Panel discussion 10:00 – 11:30
Novelties in regulating drug circulation within the Eurasian Economic Unio
Время: 10:00 - 11:30
• 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)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - PRO.MED.CS Praha a.s.
Continuation of panel discussion 11:50
Novelties in regulating drug circulation within the Eurasian Economic Union
Время: 11:50 - 13:30
•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)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - Petrovax Pharm
Semen Zhavoronkov
Advisor to the Co-Chairman of the All-Russia Public Organization “Business Russia”
Semen Zhavoronkov
Advisor to the Co-Chairman of the All-Russia Public Organization “Business Russia”
Participates
Panel discussion 11:50 – 13:20
Inspection of manufacturers of drugs for veterinary use. Regulation and statistics. The view of the state and business
Время: 11:50 - 13:20
• Regulation of inspection of manufacturers of drugs for veterinary use under EAEU rules
• Experience of inspecting European manufacturers of veterinary drugs
Session partner: Avpharm

Vasilina Gritsyuk
Deputy Director, the Russian State Center for Animal Feed and Drug Standardization and Quality

Vasilina Gritsyuk
Deputy Director, the Russian State Center for Animal Feed and Drug Standardization and Quality
Participates
Panel discussion 11:50 – 13:20
Inspection of manufacturers of drugs for veterinary use. Regulation and statistics. The view of the state and business
Время: 11:50 - 13:20
• Regulation of inspection of manufacturers of drugs for veterinary use under EAEU rules
• Experience of inspecting European manufacturers of veterinary drugs
Session partner: Avpharm

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

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