This interactive meeting will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation, which came into force in 2016.
The aim of this meeting is to provide an overview of recent regulatory developments in pharmaceutical regulatory affairs in Russia and the Eurasian Union. This interactive meeting will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation, which came into force in 2016. The focus will be on practical aspects to assist in developing your regulatory strategy for product approval in these countries and the presentations will also give practical hints on the regulatory process where possible.
Who should attend?
This seminar will be of particular interest to:
Anyone working in pharmaceutical regulatory affairs in this region
Anyone interested in an update of recent developments
After attending this programme you will:
Understand the competitive landscape of the growing markets in CIS region
Discover the essential information on the new regulations and registration procedures in the Eurasian Customs Union
Discuss national requirements and guidance for drug approval in core CIS markets of Russia, Kazakhstan, Belarus, Ukraine and Azerbaijan
Develop your CIS Regional Submission Plan and place it within the global regulatory strategy
Gain practical advice from industry experts working in CIS region
Attending this programme will:
Give you the full background to the CIS pharmaceutical market
Ensure that you understand the full implications of the new regulations which will effect how you do business in the Eurasian Economic Union (EAEU)
Help clarify the document requirements and timelines of national procedures and EAEU registration procedures
Fully update you on the national regulations in Russia, Belarus, Kazakhstan, Ukraine and other CIS countries
Agenda:
Introduction and welcome
Russia - competitive landscape
Current market and projected growth
Pharma-2020 and Health-2020 State programmes
Pricing and reimbursement
Patent and data protection
Clinical trials in Russia and CIS
Russia and CIS in global clinical research
Clinical trial requirements
Local registrations trials in Russia, CIS and the Eurasian Union
Marketing authorisations in Russia
Regulatory authorities in Russia
Key regulations governing the MAA process
Registration procedures
Application dossier requirements
CIS - regional regulatory overview
CIS pharmaceutical market
CIS regional regulation co-operation - the Eurasian Union
CIS regulatory barriers for Market Access
Marketing authorisations in CIS
New Eurasian MAA procedure
Common regional requirements in CIS:
- administrative data - translations - CPP - Dossier format - local normative documents - samples - labelling
Country specific requirements for MAAs: - Ukraine, Kazakhstan, Belarus, Moldova, Georgia, Armenia, Azerbaijan, Uzbekistan, Tajikistan, Turkmenistan, Kirgizstan Regional regulatory strategy
Workshop - CIS Regional Regulatory Strategy
Discussion will take place throughout the two days
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