Panel session

10:00 — 11:30

Main hall


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


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


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