Panel session
Main hall
SCIENCE-BASED APPROACH TO PHARMACEUTICAL MANUFACTURING
Questions and topics for discussion:
- Goals, objectives and intermediate results of the activities by the Expert Council of the Eurasian Academy of Good Practices
- Approaches to microbiological monitoring of the production environment during the production of medicines. Requirements and practice in the application thereof.
- Scientific evidence of the toxicological assessment to confirm the possibility of manufacturing medicinal products on the same production line
- Toxicological evaluation of medicines for the purposes of compliance with the good manufacturing practice
- Draft Annex 1 – Requirements for Manufacture of Sterile Medicinal Products
- Qualified persons
- Requirements for the manufacture of ATMPs
MODERATORS
![](https://gosgmp.ru/wp-content/uploads/2023/05/sottaeva.jpg)
Madina Sottaeva
Head of Pharmaceutical Manufacturing Production Inspection Department of the Federal State Institution «SID and GP» under the Ministry of Industry and Trade of the Russian Federation
SPEAKERS
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Nadezhda Arkhipova
Deputy Head of the Directorate for Inspection of Medicines Manufacturers, Federal State Institution “SID and GP”, Ministry of Industry and Trade of the Russian Federation
![](https://gosgmp.ru/wp-content/uploads/2023/09/burlakina-1024x873.jpg)
Natalya Burlakina
Deputy Head of the Expertise Department of the FSI «SID and NP» of the Ministry of Industry and Trade of the Russian Federation
![](https://gosgmp.ru/wp-content/uploads/2023/09/chernyavskaya-712x1024.jpg)
Asya Chernyavskaya
![](https://gosgmp.ru/wp-content/uploads/2023/05/vyazmina-1.jpg)
Tatiana Vyazmina
Quality Director, R-Pharm Group
![](https://gosgmp.ru/wp-content/uploads/2023/09/dnd·dµd²d°nnn
-d¿nd¾n-1d-1024x683.jpg)
Lyudmila Guzevatykh
Head of the GMP Processes Toxicology Group, R-Pharm Group
![](https://gosgmp.ru/wp-content/uploads/2023/05/maklakova-olga-1024x683.jpg)
Olga Maklakova
![](https://gosgmp.ru/wp-content/uploads/2023/09/ye-xiao-1024x768.jpg)
Ye Xiao
GMP inspector, Food and Drug Inspection Center (CFDI), China