Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union: 2-Day Interactive Course (London, United Kingdom - March 2-3, 2020)

DUBLIN, Jan. 28, 2020 /PRNewswire/ -- 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 pharmaceutical markets in Russia, the Eurasian Union, and the CIS are of growing commercial importance and companies looking to take advantage of the opportunities available need to be fully up to date with the evolving regulatory landscape, including the potential for market access offered by the latest legislation.

This interactive course will guide you through national procedures as well as exploring the implications of and updates on the Eurasian Union regulation.

The focus of the programme is to offer practical advice in developing your regulatory strategy for product approval in these countries and you will get the full benefit of our trainer's experience and expertise in the region.

Benefits of attending:

• Understand the competitive landscape of the growing markets in the CIS region
• Discover the essential information on the latest regulations and registration procedures in the Eurasian Customs Union
• Discuss national requirements and guidance for drug approval in the core CIS markets of Russia, Kazakhstan, Belarus, Ukraine, and Azerbaijan
• Develop your CIS regional submission plan and place it within your global regulatory strategy
• Gain practical advice from an industry expert working in the CIS region

Attending this programme will:

• Give you the full background to the CIS pharmaceutical market
• Ensure that you understand all the implications of the latest 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
• Update you on the national regulations in Russia, Belarus, Kazakhstan, Ukraine and other CIS countries

Who Should Attend?

This seminar will be of particular interest to all those who need to learn about successful marketing authorisation applications and regulatory compliance in this region. The seminar will be useful either as an introductory or refresher course.

Agenda

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

• Eurasian MAA procedure and latest guidances
• 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, Kyrgyzstan

Regional regulatory strategy

• Workshop - CIS regional regulatory strategy

Discussion sessions will take place throughout the two days

For more information about this conference visit https://www.researchandmarkets.com/r/xtkrjk

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Research and Markets
Laura Wood, Senior Manager
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