DUBLIN, Dec. 13, 2017 /PRNewswire/ --
The "Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union" conference has been added to Research and Markets' offering.
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
For more information about this conference visit https://www.researchandmarkets.com/research/634lv2/two_day_seminar?w=5
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Research and Markets
Laura Wood, Senior Manager
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