International practical conference «EAEU unified pharmaceuticals market»

International practical conference «EAEU unified pharmaceuticals market»


Dates: October 18-19, 2023

Format: offline and online

Main topics:

  • Major changes in regulatory procedures under the EAEU Rules
  • Analysis of cases on registration, making changes, bringing them into line, as well as confirming registrations in different countries
  • Introduction of amendments to the rules of the EAEU simultaneously with harmonization and a separate procedure, opinion and practice of the Regulators
  • Laboratory examination for a biological product, online examination experience
  • Technical requirements for a dossier for recognition in different countries of the EAEU
  • Submission of materials to the farm. expertise (terms, requirements, life hacks)
  • Technical features and recommendations for preparing a dossier in CTD format (software, document versioning, etc.)
  • Pharmacopoeia of the EAEU
  • Experience in bringing into compliance in the Russian Federation as a reference country
  • GMP inspection of foreign and local sites
  • Bringing the dossier of drugs from blood plasma into line with the EAEU - the practice of compiling and registering PMF from foreign manufacturers
  • Simplification of the requirements for completeness of dossiers for the EAEU, removal of the limitation period (31.12.2025)
  • Cases and recommendations from Regulators of the countries on the issues of harmonization, introduction of changes Grouping of variations (which variations can be combined in one Application). Practical experience of other companies. Key concerns/comments from the authorities
  • Unification of the approach to the formation of the ND number
  • OFS for Mechanical inclusions. Visible particles; The order of the procedure for considering disagreements when recognizing a dossier
  • Comparative characteristics of the comments of various regulators, differences in approaches during the examination
  • State regulation of drug circulation
  • Required amount of clinical data when registering different types of medicines in the EAEU
  • Computerized systems in the implementation of pharmacovigilance activities at a pharmaceutical enterprise: issues of data integrity

Conference format:

  • online / offline
  • no more than 70 participants, for convenient communication
  • simultaneous translation (Russian, English)
  • each presentation is 40-45 minutes
  • possibility to ask questions after each report

For more information, please, contact us:

+3 57 22 007896
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For more information about the events. please contact us:
 This email address is being protected from spambots. You need JavaScript enabled to view it.