International Practical Conference “EAEU Single Market. Registration and re-registration of medicines “

On September 16-17, 2021, Moscow will host the International Practical Conference “The EAEU Single Market. Registration and re-registration of medicines ”

The main topics of the conference:

• Review of changes in the rules for registration and examination of medicines
• Experience of registration and harmonization in the countries of recognition
• Preparation of the registration dossier for the original drug and generic
• Differences in registration and harmonization 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 medicinal products in the EU, USA
• Experience in registration of a biotechnological / biological / immunobiological drug in the EAEU. ND specification
• Requirements for the electronic form of applications and documents of the registration dossier in XML format
• Experience of registration and harmonization of medicinal products in the EAEU with a medical device
• Experience in passing drug inspections according to the rules of the EAEU
• 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?

Based on site materials https://gxpnews.net/event/mezhdunarodnaya-prakticheskaya-konferencziya-edinyj-rynok-eaes-registracziya-i-pereregistracziya-lekarstvennyh-sredstv/