DUBLIN--(BUSINESS WIRE)--The "Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union" conference has been added to ResearchAndMarkets.com's offering.
This interactive course will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation.
The aim of the course is to provide an overview of recent developments in pharmaceutical regulatory affairs in Russia, the Eurasian Union and the CIS.
The course will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation.
The focus will be on practical aspects to assist in developing your regulatory strategy for product approval in these countries and the presentations will give practical hints on the regulatory process where possible.
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 affect 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
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Common regional requirements in CIS
Workshop - CIS Regional Regulatory Strategy
For more information about this conference visit https://www.researchandmarkets.com/research/73hbh7/2day_course?w=4
