International practical conference «Launching pharmaceuticals to the EAEU market»
Dates: March 22-23, 2023
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:
• Making changes, practical experience from applicants and regulators
• Alignment of the dossier of a biotechnological product
• Legislative basis for organizing consultations with regulatory authorities on issues of state registration of medicines. Existing practice in the EAEU member states
• Prospects for maintaining local registration of medicines in each of the EAEU member states after 2025
• The approach of the authorities of different states to the documentation confirmed in the reference state
• Quality control of medicines in the world practice during registration, making changes to the dossier and post-registration QC of the medicinal product
• Laboratory expertise:
• applicant's experience - in terms of terms, features of registration in different countries;
• regulator approaches;
• experience in the EAEU: when regulators appoint an examination, how long is given for submitting samples, common mistakes;
• experience in conducting remote laboratory examinations in the EAEU
• Calculations for PV during registration of the EAEU, opinions of experts and the industry
• Pharmacopoeia of the EAEU
• Registration of hybrid drugs. Registration of combined drugs
• Registration of biological preparations, preparations from blood plasma
• Practical experience after alignment, what difficulties companies face
• Registration and maintenance (changes) of the plasma master file in the EAEU
• State regulation of the circulation of medicines
• Registration of drugs in the CIS countries
• Registration of new drugs, experience of registration without conducting clinical trials in the EAEU
• Matching for well-studied LPs
• Preparation of a dossier according to the requirements of the EAEU 1,2,3,4,5 modules
• Alignment of the dossier of a biotechnological product. Experience of a new registration of a biotechnological drug. Experience on defective drugs in accordance with PP 593
• Main changes in regulatory procedures under the EAEU Rules
• Ghost in the countries of recognition and introduction into the civil defense and problems associated with this for drugs listed in the EAEU
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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