Pharma in Eurasia: Ensuring Intellectual Property RIGHTS in the EAEU
Free to attend
What will be discussed?
- The improvement of the legislative framework and development of Eurasian regulators in IP and RDP protection
- The formation of campaigns/ approaches and the protection period for the results of CT and pre-clinical trials within the EAEU.
- The protection of rights of the originators at the drug registration stage versus the improvement of methods of dispute in court. Which areas should be a priority?
- The mechanisms of ensuring proper protection of IP rights at a national level
- The general registration versus another patent status’ of drugs in EAEU countries
Speaker and Panelists include
- Moderator: Irina Sheykha, Legal and IP Rights Director, Association of International Pharmaceuticals Manufacturers (AIPM Russia)
- Olzhas Satybaldin, Head of Government Affairs, AstraZeneca Russia & Eurasia
- Nikita Ivanov, Senior Director Corporate Affairs, Health & Value and Communications, Pfizer Eurasia & Baltics
- Alexey Kislitsyn, Senior Director of Legal Department, Gilead Sciences
- Mukhammadali Makhmudov, Managing partner, Trademark and Patent Attorney (Intellectual property counsel), Legalmax
Pharma in Eurasia: “Issues of registration and re-registration of drugs within the EAEU”
As of today, there are not many drug registrations on the unified register of the Eurasian Economic Union if we consider the total number of medicines circulating within the single market. Despite the existing procedures and lists of drug registration documents presented by regulatory agencies, or re-registration in accordance with EAEU legislation, pharmaceutical companies still have a number of questions.
Join an interactive discussion regarding the approval of the reference state by other countries in EAEU member states, as well as an analysis of the best practices for submitting CT data and the preparation of the dossier for successful drug registration.
Pharma in Eurasia: “Clinical trials in the EAEU- regulation and recovery strategies”
We invite you to join our virtual platform to exchange ideas and get a sense of how the current situation continues to affect clinical research, what kind of issues professionals in the sector face and how they solve them, what concerns the industry most and how the experts’ picture industry developing after Covid-19.
Among the topics for discussions were:
- Regulation of CT in the EAEU and the issues related to current legislative changes in the field of CT.
- Harmonisation and unification of the supranational EAEU legislative model and the local legislation within participating EAEU member states.
- CT sector and the evolution of operational standards within the industry (evaluation of CT risk management, evolution of monitoring, SDR, SDV, quality issues, patient recruitment and working with new centres).
Pharma in Eurasia: “Kazakhstan. Regulation and business- the new structure of the pharmaceutical sector”
The event provides an overview of current changes in regulatory structures within the Republic of Kazakhstan, the reformatting of state regulatory priorities, as well as approaches to drug provision in the national pharmaceutical market.
During the meeting, the more challenging aspects of companies’ adaptation to current changes were analysed, existing and projected volumes of the demand for drugs were presented, and priority issues for the industry were discussed with regard to the simplification of bureaucratic procedures (certification, registration etc.) and the integration of Eurasian legislation in the field of drug circulation within the regulatory framework of Kazakhstan.