Panel discussion 10:00 – 11:30
Watch the program10:00 - 11:30
Panel discussion
Novelties in regulating drug circulation within the Eurasian Economic Unio
Questions and topics for discussion:
• Pressing issues pertaining to the integration within the single pharmaceutical market of the EAEU
• Review of current changes in the laws and regulations
• New level III documents
• Inspection procedure in accordance with the EAEU rules (as part of the registration procedures and on the request of the national Ministry of Health)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - PRO.MED.CS Praha a.s.
Moderator
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
Elena Denisova has the experience and knowledge in the areas of registration and reregistration of foreign and domestic medicines, and inspecting of medicines manufacturers on compliance with GMP requirements. She has a certificate of GMP Inspector, issued by WHO.
From January 2014 Elena Vladimirovna had been in charge of Division for medicines manufacturing licensing of the Department for pharmaceutical and medical industry development.
In May 2017 she was appointed the Deputy Director of the Department for pharmaceutical and medical industry development of Minpromtorg of Russia.
Almost 9 years Elena Denisova was working in Roszdravnadzor, where, as well, she was in charge of medicines registration area.
Her general experience in pharmaceutical field is 20 years, including employment in major companies, manufacturing medicines – 5 years.
Participates
Panel discussion 12:20 – 13:50
Interdisciplinary approach to regulating good practices (GxP)
Время: 12:20 - 13:50
Questions and topics for discussion:
● 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
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● 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
Questions and topics for discussion:
● 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.
More
● 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
Questions and topics for discussion:
• Pressing issues pertaining to the integration within the single pharmaceutical market of the EAEU
• Review of current changes in the laws and regulations
• New level III documents
• Inspection procedure in accordance with the EAEU rules (as part of the registration procedures and on the request of the national Ministry of Health)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - PRO.MED.CS Praha a.s.
More
• 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
Questions and topics for discussion:
•Pressing issues pertaining to the integration within the single pharmaceutical market of the EAEU
• Review of current changes in the laws and regulations
• New level III documents
• Inspection procedure in accordance with the EAEU rules (as part of the registration procedures and on the request of the national Ministry of Health)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - Petrovax Pharm
More
•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
Questions and topics for discussion:
● Issues relating to the organization of the aseptic manufacturing of biological products
With the support of General partner company - National Immunobiological Company” (Nacimbio)
More
● 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
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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
Education and professional activities:
- 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).
Area of practical interest:
Clinical studies of drugs, biological statistics, clinical pharmacology.
Research:
The planning, implementation and quality assurance of more than 140 studies reproduced (generic) drugs in the Republic of Belarus, 30 clinical trials of medicines (Allergy, cardiology, neurology, ophthalmology) I and III phases.Participates
Panel discussion 10:00 – 11:30
Novelties in regulating drug circulation within the Eurasian Economic Unio
Время: 10:00 - 11:30
Questions and topics for discussion:
• Pressing issues pertaining to the integration within the single pharmaceutical market of the EAEU
• Review of current changes in the laws and regulations
• New level III documents
• Inspection procedure in accordance with the EAEU rules (as part of the registration procedures and on the request of the national Ministry of Health)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - PRO.MED.CS Praha a.s.
More
• 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
Questions and topics for discussion:
•Pressing issues pertaining to the integration within the single pharmaceutical market of the EAEU
• Review of current changes in the laws and regulations
• New level III documents
• Inspection procedure in accordance with the EAEU rules (as part of the registration procedures and on the request of the national Ministry of Health)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - Petrovax Pharm
More
•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
Participants
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
Questions and topics for discussion:
• Pressing issues pertaining to the integration within the single pharmaceutical market of the EAEU
• Review of current changes in the laws and regulations
• New level III documents
• Inspection procedure in accordance with the EAEU rules (as part of the registration procedures and on the request of the national Ministry of Health)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - PRO.MED.CS Praha a.s.
More
• 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
Questions and topics for discussion:
•Pressing issues pertaining to the integration within the single pharmaceutical market of the EAEU
• Review of current changes in the laws and regulations
• New level III documents
• Inspection procedure in accordance with the EAEU rules (as part of the registration procedures and on the request of the national Ministry of Health)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - Petrovax Pharm
More
•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
Questions and topics for discussion:
• Pressing issues pertaining to the integration within the single pharmaceutical market of the EAEU
• Review of current changes in the laws and regulations
• New level III documents
• Inspection procedure in accordance with the EAEU rules (as part of the registration procedures and on the request of the national Ministry of Health)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - PRO.MED.CS Praha a.s.
More
• 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
Questions and topics for discussion:
•Pressing issues pertaining to the integration within the single pharmaceutical market of the EAEU
• Review of current changes in the laws and regulations
• New level III documents
• Inspection procedure in accordance with the EAEU rules (as part of the registration procedures and on the request of the national Ministry of Health)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - Petrovax Pharm
More
•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
Questions and topics for discussion:
• Pressing issues pertaining to the integration within the single pharmaceutical market of the EAEU
• Review of current changes in the laws and regulations
• New level III documents
• Inspection procedure in accordance with the EAEU rules (as part of the registration procedures and on the request of the national Ministry of Health)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - PRO.MED.CS Praha a.s.
More
• 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
Questions and topics for discussion:
•Pressing issues pertaining to the integration within the single pharmaceutical market of the EAEU
• Review of current changes in the laws and regulations
• New level III documents
• Inspection procedure in accordance with the EAEU rules (as part of the registration procedures and on the request of the national Ministry of Health)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - Petrovax Pharm
More
•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
Questions and topics for discussion:
• Pressing issues pertaining to the integration within the single pharmaceutical market of the EAEU
• Review of current changes in the laws and regulations
• New level III documents
• Inspection procedure in accordance with the EAEU rules (as part of the registration procedures and on the request of the national Ministry of Health)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - PRO.MED.CS Praha a.s.
More
• 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
Questions and topics for discussion:
•Pressing issues pertaining to the integration within the single pharmaceutical market of the EAEU
• Review of current changes in the laws and regulations
• New level III documents
• Inspection procedure in accordance with the EAEU rules (as part of the registration procedures and on the request of the national Ministry of Health)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - Petrovax Pharm
More
•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
Questions and topics for discussion:
• Pressing issues pertaining to the integration within the single pharmaceutical market of the EAEU
• Review of current changes in the laws and regulations
• New level III documents
• Inspection procedure in accordance with the EAEU rules (as part of the registration procedures and on the request of the national Ministry of Health)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - PRO.MED.CS Praha a.s.
More
• 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
Questions and topics for discussion:
•Pressing issues pertaining to the integration within the single pharmaceutical market of the EAEU
• Review of current changes in the laws and regulations
• New level III documents
• Inspection procedure in accordance with the EAEU rules (as part of the registration procedures and on the request of the national Ministry of Health)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - Petrovax Pharm
More
•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
Questions and topics for discussion:
• Pressing issues pertaining to the integration within the single pharmaceutical market of the EAEU
• Review of current changes in the laws and regulations
• New level III documents
• Inspection procedure in accordance with the EAEU rules (as part of the registration procedures and on the request of the national Ministry of Health)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - PRO.MED.CS Praha a.s.
More
• 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
Questions and topics for discussion:
•Pressing issues pertaining to the integration within the single pharmaceutical market of the EAEU
• Review of current changes in the laws and regulations
• New level III documents
• Inspection procedure in accordance with the EAEU rules (as part of the registration procedures and on the request of the national Ministry of Health)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - Petrovax Pharm
More
•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
Questions and topics for discussion:
• Pressing issues pertaining to the integration within the single pharmaceutical market of the EAEU
• Review of current changes in the laws and regulations
• New level III documents
• Inspection procedure in accordance with the EAEU rules (as part of the registration procedures and on the request of the national Ministry of Health)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - PRO.MED.CS Praha a.s.
More
• 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
Questions and topics for discussion:
•Pressing issues pertaining to the integration within the single pharmaceutical market of the EAEU
• Review of current changes in the laws and regulations
• New level III documents
• Inspection procedure in accordance with the EAEU rules (as part of the registration procedures and on the request of the national Ministry of Health)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - Petrovax Pharm
More
•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
Questions and topics for discussion:
● Issues relating to the organization of the aseptic manufacturing of biological products
With the support of General partner company - National Immunobiological Company” (Nacimbio)
More
● 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
Questions and topics for discussion:
• Pressing issues pertaining to the integration within the single pharmaceutical market of the EAEU
• Review of current changes in the laws and regulations
• New level III documents
• Inspection procedure in accordance with the EAEU rules (as part of the registration procedures and on the request of the national Ministry of Health)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - PRO.MED.CS Praha a.s.
More
• 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
Questions and topics for discussion:
•Pressing issues pertaining to the integration within the single pharmaceutical market of the EAEU
• Review of current changes in the laws and regulations
• New level III documents
• Inspection procedure in accordance with the EAEU rules (as part of the registration procedures and on the request of the national Ministry of Health)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - Petrovax Pharm
More
•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
Questions and topics for discussion:
• Pressing issues pertaining to the integration within the single pharmaceutical market of the EAEU
• Review of current changes in the laws and regulations
• New level III documents
• Inspection procedure in accordance with the EAEU rules (as part of the registration procedures and on the request of the national Ministry of Health)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - PRO.MED.CS Praha a.s.
More
• 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
Questions and topics for discussion:
•Pressing issues pertaining to the integration within the single pharmaceutical market of the EAEU
• Review of current changes in the laws and regulations
• New level III documents
• Inspection procedure in accordance with the EAEU rules (as part of the registration procedures and on the request of the national Ministry of Health)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - Petrovax Pharm
More
•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
Questions and topics for discussion:
• Pressing issues pertaining to the integration within the single pharmaceutical market of the EAEU
• Review of current changes in the laws and regulations
• New level III documents
• Inspection procedure in accordance with the EAEU rules (as part of the registration procedures and on the request of the national Ministry of Health)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - PRO.MED.CS Praha a.s.
More
• 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
Questions and topics for discussion:
•Pressing issues pertaining to the integration within the single pharmaceutical market of the EAEU
• Review of current changes in the laws and regulations
• New level III documents
• Inspection procedure in accordance with the EAEU rules (as part of the registration procedures and on the request of the national Ministry of Health)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - Petrovax Pharm
More
•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
Questions and topics for discussion:
• Pressing issues pertaining to the integration within the single pharmaceutical market of the EAEU
• Review of current changes in the laws and regulations
• New level III documents
• Inspection procedure in accordance with the EAEU rules (as part of the registration procedures and on the request of the national Ministry of Health)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - PRO.MED.CS Praha a.s.
More
• 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
Questions and topics for discussion:
•Pressing issues pertaining to the integration within the single pharmaceutical market of the EAEU
• Review of current changes in the laws and regulations
• New level III documents
• Inspection procedure in accordance with the EAEU rules (as part of the registration procedures and on the request of the national Ministry of Health)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - Petrovax Pharm
More
•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
Questions and topics for discussion:
• Pressing issues pertaining to the integration within the single pharmaceutical market of the EAEU
• Review of current changes in the laws and regulations
• New level III documents
• Inspection procedure in accordance with the EAEU rules (as part of the registration procedures and on the request of the national Ministry of Health)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - PRO.MED.CS Praha a.s.
More
• 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
Questions and topics for discussion:
•Pressing issues pertaining to the integration within the single pharmaceutical market of the EAEU
• Review of current changes in the laws and regulations
• New level III documents
• Inspection procedure in accordance with the EAEU rules (as part of the registration procedures and on the request of the national Ministry of Health)
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union
Session partner company - Petrovax Pharm
More
•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
