International Practical conference «EAEU Unified pharmaceuticals market»
Dates: October 5-6 2022
Format: offline and online
Invited speakers:
Ministry of Health of the Russian Federation, Eurasian Economic Commission, Federal State Budgetary Institution "Scientific Center for Expertise of Medicinal Products" of the Ministry of Health of Russia, Republican State Enterprise on REM "National Center for Expertise of Medicines and Medical Devices" Kazakhstan, UE Center for Expertise and Testing in Healthcare of the Republic of Belarus, the Department of Medicines and Medical Devices under the Ministry of Health of the Kyrgyz Republic, drug manufacturers and solution providers.
Main topics:
✓ Main changes in the rules for registration and examination of medicines in the EAEU
✓ Experience in registration of a biotechnological medicinal product. Difference in registration of the original drug and biosimilar
✓ Registration of medical devices.
✓ Experience in registration of hybrid drugs. Requirements for conducting CT, bioequivalence
✓ The composition of the dossier for the original drug and generic
✓ Special procedures for registration in the EAEU (registration with additional requirements, registration in exceptional cases, conditional registration, accelerated registration)
✓ Quality control of medicines in the world practice during registration, making changes to the dossier and post-registration QC of the medicinal product
✓ EAEU Pharmacopoeia
✓ Frequent remarks to reg. dossier during registration, adjustment, amendment procedures
✓ Risks of drug circulation after the dossier adjustment procedure
✓ User testing. Expert comments to the leaflet, reports
✓ Experience in making changes in the reference country and countries of recognition. Making changes simultaneously with bringing the dossier in line
✓ Experience of registration and bringing in countries of recognition
✓ Module 3 of the registration dossier
✓ Formation of an electronic registration dossier within the framework of union procedures in the reference state and states of recognition
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:
+7 499 6776159
+3 57 22 007896
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