International practical conference «Registration of pharmaceuticals according to the rules of the EAEU»
Dates: April 01-02 2026, Moscow
Format: offline and online
Main topics:
- Peculiarities of the initial registration of generic, biosimilar, and original drugs. Current trends and features;
- Amending the registration dossier - merging two registration dossiers for drugs with different dosages into one (type of change);
- Reliance procedures and the views of regulators in the EAEU countries on the development of this issue;
- Electronic instructions for medical use, benefit/risk assessment, laboratory examination;
- Peculiarities of regulation in the Republic of Belarus, Uzbekistan, the Russian Federation, and Azerbaijan;
- Registration/re-registration/amendments in the Republic of Uzbekistan;
- Registration of dietary supplements in the EAEU, experience of a decentralized registration procedure;
- Peculiarities of amending the registration dossier in accordance with EAEU requirements;
- Registration of medical devices;
- Clinical trials of drugs. Clinical development of drugs;
- Inquiries to the regulatory document on quality, classification of changes according to Decision 78;
- STKR in reg. Dossiers in the drug life cycle: types of changes, study requirements, opportunities to reduce the number of trials;
- Registration initiated by authorized bodies;
- Possibility of aligning registration documents in states of recognition registered under a strategic order (Kazakhstan);
- Remote examination, conditional registration;
- Specifics of registering high-tech medicinal products;
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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