International Practical conference «Unified EAEU market. Registration and re-registration of pharmaceuticals»
Bravo Business Forum: International Practical conference «Unified EAEU market.Registration and re-registration of pharmaceuticals»
16-17 September 2021, Moscow, Russia and online
Main Topics for discussion:
• 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?
For more information, please visit the event's website.