International practical conference «EAEU unified pharmaceuticals market»

Dates: March 27-28 2024
Format: offline and online

Main topics:

✓ Major changes in regulatory procedures under the EAEU Rules
✓ Recognition procedure, decentralized procedure, registration/alignment of
biosimilars
✓ The regulator’s requirement regarding recognition and harmonization
✓ GCP inspections
✓ Drawing up a regulatory document for FMP taking into account the requirements of
the EEC
✓ Recognition in the Russian Federation: features, percentage of accepted dossiers
✓ Experience of bringing into compliance in the Russian Federation as a reference
country
✓ Pharmacopoeia of the EAEU
✓ Pricing in the EAEU countries after completion of the recognition procedure.
Movement of goods on the territory of the Member States after completion of the
recognition procedure, regulatory framework, practice
✓ Amendments to the reg. dossier after confession
✓ Current situation regarding obtaining orphan status in different EAEU countries
✓ Practical experience of inspection according to the rules of the EAEU
pharmacovigilance system
✓ Features of harmonization, new registration and amendments to biotechnological
drugs
✓ Features of submitting a dossier to the Reference State and State of Recognition
with different owners of the Registration Certificate in the Reference State and State
of Recognition
✓ Registration in Armenia, new registration of the EAEU (experience of
pharmaceutical examination with delivery of samples), expansion of registration
✓ Experience in bringing reg. dossier in accordance with the requirements of the
EAEU for a decentralized procedure
✓ Requirements for clinical trials for inclusion in the registration dossier
✓ User testing in countries of recognition (features, risks, life hacks)
✓ Procedure for registration and subsequent circulation of dietary supplements.
Entry into force of the medical registration rules. EAEU products
✓ Amendments to the EAEU procedure, comments, recommendations
✓ Refusals of registration, recognition
✓ Experience in obtaining the status of a particularly significant drug
✓ Serialization on a single market - prospects for harmonization and circulation of a
single package
✓ Introduction to circulation on the single market - prospects for harmonization

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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