Composition of the Expert Council
Composition of the Expert Council
ABOUT THE WORK GROUPS
ABOUT THE WORK GROUPS
The working (thematic) group of the Expert Council of the Academy is a consultative group, which is created to solve individual tasks within the competence of the Expert Council.
The working (thematic) group shall be guided by the law of the Eurasian Economic Union (hereinafter referred to as the Union), the national legislation of the Union member states, as well as the Charter of the Academy.
The main functions of the working (thematic) group:
WORKGROUP ROSTER
WORKGROUP ROSTER
🔹 Draft Appendix No. 1 "Requirements for Production of Sterile Drugs
🔹 Scientific toxicological evaluation data to confirm the possibility of combining products on the same production line
🔹 Scientific and methodological approaches to quality control issues (microbiology)
🔹 Pharmaceutical engineering
🔹 Authorized persons
🔹 Rules for pharmaceutical inspections of the EAEU
🔹 Draft Part IV "Requirements for Production of High-Technology Drugs
WORKING GROUP ON THE TOPIC
WORKING GROUP ON THE TOPIC
Draft Annex No. 1 "Requirements for the production of sterile drugs
Target:
Objectives:
Manager:

Nadezhda Valentinovna Arkhipova
Team:
WORKING GROUP ON THE TOPIC
WORKING GROUP ON THE TOPIC
"Scientific toxicological evaluation data to confirm the feasibility of combining products on the same production line"
Target:
Objectives:
Areas of application of toxicological assessment:
🔹The relationship between the scientific data of toxicological assessment and cross-contamination risk assessment (significance of physical and chemical properties);
🔹Differences in approaches to toxicological assessment for drugs of different groups (chemical synthesis drugs, biotechnology drugs, organ preparations, blood products, vaccines, etc.)
Managers:

Tatyana Mikhailovna Vyazmina

Lyudmila Sergeyevna Guzevatykh
Team:
WORKING GROUP ON THE TOPIC
WORKING GROUP ON THE TOPIC
"Scientific and methodological approaches to quality control issues (microbiology)"
Target:
Objectives:
Manager:

Asya Anatolievna Chernyavskaya
Team:
WORKING GROUP ON THE TOPIC
WORKING GROUP ON THE TOPIC
"Pharmaceutical Engineering"
Target:
Objectives:
Manager:

Igor Vsevolodovich Falkovsky
Team:
WORKING GROUP ON THE TOPIC
WORKING GROUP ON THE TOPIC
"Authorized Persons"
Target:
Objectives:
Manager:

Olga Valentinovna Maklakova
The team:
WORKING GROUP ON THE TOPIC
WORKING GROUP ON THE TOPIC
"Rules for pharmaceutical inspections of the EAEU"
Target:
Objectives:
Managers:

Elena Borisovna Lavnik

Madina Magometovna Sottaeva
Team:
WORKING GROUP ON THE TOPIC
WORKING GROUP ON THE TOPIC
Project of Part IV "Requirements for Production of High-Technology Drugs
Target:
Objectives:
Manager:

Natalya Vladimirovna Burlakina