International Practical conference «Unified EAEU market.Registration and re-registration of pharmaceuticals»
Dates: September 16-17, 2021
Venue: Moscow, Russia
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.
• Review of changes in the registration and examination rules of medicines
• Preparation of the registration dossier for the original drug and generics
• Differences in registration of prescription and non-prescription drugs
• Experience in making changes in the reference country and countries of recognition
• Experience of registration and harmonization in the reference country (Kazakhstan, Belarus, Armenia, Kyrgyzstan)
• Differences in filing an application for GMP inspection and in the inspection procedure in the Russian Federation and the EAEU. Practical experience
• Problems of technical cooperation in the states of recognition
• Registration and harmonization of drugs in the EU, USA
• Experience in registration of a biotechnological / biological / immunobiological drug in the EAEU. ND specification
• Experience of registration of medicinal products in the EAEU with a medical device
• Working with DMF (master file for a pharmaceutical substance) in Europe: how it is prepared, where it is submitted, the terms of approval, how to work with DMF after approval. How does it work in the Russian Federation?
• Working with the master file of plasma and vaccine antigen in Europe: how it is prepared, where it is served, the terms of approval, how to work with the master file after approval. How does it work in the Russian Federation?
• Working with CEP in Europe: how they prepare, where they serve, the terms of approval, how to work with CEP after approval. How does it work in the Russian Federation?
• 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