International practical conference «Registration of pharmaceuticals according to the rules of the EAEU»
DATES: April 02-03 2025
FORMAT: offline and online
Main topics:
• Confirmation of registration and filing of amendments
• Registration of strategically important drugs in Kazakhstan: what will happen after 2025
• Reasons for refusal in the reference country and in the countries of recognition
• The approach of ALL countries regarding various aspects (DRU, name, difference in analytical methods)
• Features of bringing the registration dossier into compliance with the requirements of the EAEU in Armenia, Kyrgyzstan
• Features of forming a registration dossier to bring it into compliance with the requirements of the EAEU in Kazakhstan
• Typical mistakes of the applicant when bringing it into compliance
• Experience of filing amendments, with quality control of samples
• Examples of the recognition procedure for issues and deadlines, appointment of pharmaceutical inspections within or after registration - experience, reasons for appointment
• Features of registration of kits with MI - experience of companies and regulators
• Changes to the rules of the EAEU
• Expansion of registration, practical experience
• Recognition procedures in Kyrgyzstan, Armenia
• Working tools for applicants in Kazakhstan
• Variations of type 1B and 2, what the regulator expects (Belarus, Kazakhstan, Armenia, Kyrgyzstan)
• Biotechnological drugs, development and research
• Requirements for documents of modules 1-5 RD, features, practical cases
• Modern methods of drug analysis
• Registration of dietary supplements in the EAEU
• Experience of drug registration under the decentralized procedure
• Introduction into civil circulation after bringing into compliance with the requirements of the EAEU
• Introduction of labeling requirements in countries where they have not been introduced (Belarus, Armenia)
• Submission of parallel changes in the process of an unfinished recognition procedure in countries
• Experience of filing registration dossiers to the State Enterprise after the reference state (bringing into compliance, making changes)
• Examples of challenging regulators' requirements
• Procedure and requests when expanding registration
• Experience of conducting remote pharmaceutical expertise (from initiation to the final point)
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:
+ 357 22 007896
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