Yelena Denisova
Deputy Director of the Department of Pharmaceutical and Medical Industry Development, Ministry of Industry and Trade of the Russian Federation
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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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.
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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.
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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
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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)
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Master-class
Opening of Master-class “Technology Transfer. Regulatory Requirements”
Время: 10:15 - 12:25
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