International Practical conference «Unified EAEU market.New rules for registration and re-registration of pharmaceuticals»
Dates: March 30-31, 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, Federal Agency for Medicines and Medical Devices of Belgium FAMHP, 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 EAEU Pharmacopoeial Committee, the Department of Medicines and Medical Devices under the Ministry of Health of the Kyrgyz Republic, Noven Pharma USA, Biocad, Boehringer Ingelheim, Bayer, R-Pharm, drug manufacturers and solution providers.
Main topics:
• Main changes in the rules of registration and expertise of pharmaceuticals in the EAEU
• Working with the master file of plasma and vaccine antigen in Europe: how to prepare, where to serve, approval dates, how to work with the master file after approval. How it works in Russia
• Experience of registration of a biotechnological pharmaceuticals. The difference in the registration of the original pharmaceuticals and the biosimilar
• Registration of medical devices. Fundamental differences in the procedures of the Russian Federation and the EAEU. Risks when registering medicines together with medical products in one package
• Experience in registering hybrid pharmaceuticals. Requirements for conducting CT, Bioequivalence
• The composition of the dossier on the original drug and generic
• Special registration procedures in the EAEU (registration with the establishment of additional requirements, registration in exceptional cases, conditional registration, accelerated registration)
• Quality control of pharmaceuticals in the world practice during registration, amendments to the dossier and post-registration QC of the pharmaceutical product
• Pharmacopoeia of the EAEU
• Risks of circulation of pharmaceuticals after the procedure of bringing the dossier in accordance with
• User testing. Expert comments on the leaflet, reports
• Experience of making changes in the reference country and countries of recognition. Making changes simultaneously with bringing the dossier into compliance
• Registration process in Europe. Transition from national dossier formats to eCTD
• Experience of registration and alignment in countries of recognition
• Pharmacovigilance in the Russian Federation and the EAEU. Experience in the EU
• Module 3 of the registration dossier, what to pay attention to, how to issue. Frequent expert requests to Module 3
• Formation of an electronic registration dossier within the framework of Union procedures in the reference State and recognition States
• Differences in the application for GMP inspection and in the inspection procedure in the Russian Federation and the EAEU. Features and trends. Practical experience
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
This email address is being protected from spambots. You need JavaScript enabled to view it.
