Program of the VI All-Russian Conference in 2021

09:00 - 10:00

Registration of participants

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10:00 - 12:00

Opening of the Conference
Plenary session

Strong regulator – robust industry

Questions and topics for discussion:
• Structural approach in bringing the Russian industry to an international level
• Actions of the regulatory authorities during the pandemic.
• Experience of inter-agency interaction.
• Analysis of decisions made and their results
• Experience of foreign drug regulatory authorities

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12:00 - 12:20

Break

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12:20 - 13:50

Panel discussion

New elements in regulating drug circulation within the Eurasian Economic Union

Questions and topics for discussion:
• Pressing issues pertaining to the integration within the single pharmaceutical market of the EAEU
• Review of current changes in the laws and regulations
• New level III documents
• Inspection procedure in accordance with the EAEU rules (as part of the registration procedures and on the request of the national Ministry of Health) and regulators’ experience in conducting inspections of drug manufacturing
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union


Session partner: PRO.MED.CS PRAHA A.S.

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13:50 - 14:50

Lunch

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14:50 - 16:20

Continuation of panel discussion

New elements in regulating drug circulation within the Eurasian economic union

Questions and topics for discussion:
• Pressing issues pertaining to the integration within the single pharmaceutical market of the EAEU
• Review of current changes in the laws and regulations
• New level III documents
• Inspection procedure in accordance with the EAEU rules (as part of the registration procedures and on the request of the national Ministry of Health) and regulators’ experience in conducting inspections of drug manufacturing
• Issues regarding the maintenance of the EAEU register
• Pharmacopeia of the Eurasian Economic Union


Session partner: Petrovax Pharm

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16:20 - 16:40

Break

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16:40 - 18:10

Panel discussion

Current developments of the pharmaceutical market: Time and place for systemic expertise

Questions and topics for discussion:
• The need for enhancing systems of domestic pharmaceutical developments
• Compliance with GMP rules during the drug’s development phase
• Technology transfer. Scaling- up of manufacturing.
• Development of the domestic full manufacturing cycle: objectives, opportunities and perspectives
• System of state reference standards in Russia
• Main phases of drug development: active pharmaceutical substance, preclinical studies, clinical studies, registration, manufacturing

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20:00 -

Evening event

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