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
  change);
• 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
This email address is being protected from spambots. You need JavaScript enabled to view it.