Programme

November 12 download agenda
Day 1, November 12
The functionality of a single market for drugs within the Eurasian Economic Union. Strategy and regulatory approaches.

In Discussion with the Industry: Existing and new conditions of the common pharmaceutical market in the EAEU. Prospects & Challenges – how pharma companies can adapt.

 

Session: Shaping an effective regulatory policy in the EAEU countries
  • Eurasian legal system. The interaction of national legislation and Union law in regulating the functioning of the common pharmaceutical market
Discussion questions

 

  • Issues of harmonization of national and Eurasian legislation – optimal approaches and pitfalls
  • Problems of transition from national regulation to Eurasian. An experience of five countries
Extended session on drug registration within the EAEU

To what extent are EAEU member state systems ready for the new integrated registration process?

How will the Integrated IT system for the dossier submission function?

Aspects of inspection within the laws of the union.

Will there be a different emphasis during future inspections? What problems could be encountered during inspections? Liberal or restrictive measures?

November 13 download agenda
Day 2, November 13
Protection of intellectual property rights in the field of drug circulation. The balance of state, business and patients.

Drug licensing: cause and consequence; the influence on pharmaceutical business; Data protection with compulsory licensing

Drug pricing - price registration and control.

Possible suggestions of new balanced models for EAEU countries

In focus – Russia, Kazakhstan, Belarus

Monitoring Movement of Medical Products (MMMP)

How ready manufacturers and regions are for drug labelling. Results, further proposals and initiatives, current implementation issues. Movement of goods between member states in the EAEU- what do the EAEU member states plan to do?