Program of the VI All-Russian Conference in 2021
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
Panel discussion
Interdisciplinary approach to regulating good practices (GxP)
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
Continuation of panel discussion
Interdisciplinary approach to regulating good practices (GxP)
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.
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
Session partner company - Akrikhin
