International practical conference «EAEU unified pharmaceuticals market»

Dates: October 16-17 2024
Format: offline and online

Main topics:

  • Practical cases of a labeling company, using “common layouts” for all countries.
  • Information on SmPC and medicinal products;
  • Serialization in Kazakhstan and for other countries, if planned. The changes are
    “simultaneous” for everyone, as is implemented below;
  • Definition of sunset clause within the framework of drug circulation;
  • Post-registration regulation of drugs in the EAEU markets;
  • Experience of recognition in recognition states of the EAEU;
  • Orphan, biological drugs;
  • Features of drawing up ND;
  • Confirmation of registration (re-registration) of medicinal products according to the
    rules of the EAEU, Registration of dietary supplements according to the EAEU;
  • Making changes to the EAEU of all types, real examples of groupings, classifications,
    whether samples were requested or not, in what quantity, whether the calculation
    differed from the initial registration;
  • Extension of registration from the regulator;
  • Registration of drugs in Uzbekistan (regulator or local company);
  • Electronic interaction;
  • Bringing into compliance drugs that during the procedure are classified by an expert as
    hybrid, recognition of drugs for which module 4-5 contains documents from the 90s and
    obviously does not meet the requirements for clinical trials, DKI of the EAEU;
  • Classification of changes, harmonization of preparations based on premixes and pellets;
  • Mutual recognition procedure (peculiarities in member states);
  • GMP inspections;
  • Pharmacopoeia of the EAEU;
  • Laboratory examination of medicines;
  • Simplified compliance procedure, SMS Aspects
  • Changes after recognition, analytical examinations if the Russian Federation is not the
    reference country;
  • Changes related to quality (module 3) strategies and capabilities of regulators;
  • Rules for submitting quality changes after translation to the EAEU rules (what will
  • Features of the Mongolia regulator as a whole;
  • Import of API to the Russian Federation, what to consider;
  • Registration of medicines in ASIA, features of pricing in Vietnam;
  • Products included in the packaging of medicines;

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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For more information about the events. please contact us:
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