International practical conference «Registration of pharmaceuticals according to the rules of the EAEU»
DATES: September 24-25 2025, Saint Petersburg
FORMAT: offline and online
Main topics:
• Real cases of bringing/registration from scratch (errors, comments, what to pay attention to, non-standard solutions);
• Registration of drugs with several API manufacturers and several production sites. Features;
• Registration of different types of drugs (both by release form and by type of drug, combination or several manufacturers of substances, or many substances in one drug) with examples;
• Decentralized procedure: current experience and prospects;
• Conditional recognition, how to submit changes in this case;
• Kazakhstan as a state of recognition;
• Amendments to the registration dossier and expansion according to the requirements of the EAEU;
• Confirmation of drug registration according to the procedures of the EAEU;
• Procedure and requests for expansion of registration;
• Submission of parallel changes from a practical point of view, taking into account the analysis of sequences;
• Change after recognition, submission and assessment of documentation;
• Single packaging for all EAEU countries pros and cons;
• Plasma master file, biological products;
• High-tech drugs, confirmation of drug registration according to EAEU procedures;
• Variations of type 1B and 2, what the regulator expects (Russia, Belarus, Kazakhstan, Armenia, Kyrgyzstan);
• Introduction of labeling requirements in countries where they have not been introduced (Belarus, Armenia), etc.;
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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