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
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
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
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
Asya Chernyavskaya
Head of the testing center for quality control of medicines LLC IC «ML -STANDARD»
Tatiana Vyazmina
Quality Director, R-Pharm Group
Lyudmila Guzevatykh
Head of the GMP Processes Toxicology Group, R-Pharm Group
Olga Maklakova
Quality Director, Akrikhin Company
Ye Xiao
GMP inspector, Food and Drug Inspection Center (CFDI), China