Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union Training Course: Master Regulatory Procedures in CIS and Eurasian Union to Maximize Market Access (ONLINE EVENT: June 19-20, 2025)
Dublin, May 19, 2025 (GLOBE NEWSWIRE) -- The "Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union Training Course" training has been added to ResearchAndMarkets.com's offering.
This interactive course will guide you through national procedures as well as explore 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.
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 for human pharmaceuticals, including the potential for market access offered by the latest legislation.
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
Why you should attend
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
Certifications:
CPD: 12 hours for your records
Certificate of completion
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.
Key Topics Covered:
Day 1
CIS - regional regulatory overview
CIS and Russia Market Overview
Market protection policies
CIS and Russia in regional and international Regulatory Harmonisation
Common regional requirements in CIS
Administrative data, translations, normative documents, samples, labelling, etc
Eurasian economic area
Countries current members of EAEU and EAEU Official bodies
History of EUAE, scope of products, available experience
Terms of transition period for medicines
Eurasian Regulations for Medicines
Overview of EAEU regulatory framework
Registration Procedures and Application Process
EAEU submission documents and data requirements
GMP inspections
PhV requirements
Day 2
Registration of Medicine in Russia
Regulatory authorities in Russia
Key regulations governing the registration process
Clinical trials
National Regulatory Procedures in Russia
Application dossier and data requirements
Post approval life cycle maintenance applications
Safety reporting and market surveillance
Price and reimbursement
Patent data protection
Registration in other EAEU countries
Kazakhstan, Belarus, Armenia, Kirgizstan
Registration in other CIS countries
EU sphere of influence: Ukraine, Moldova, Georgia
National procedures: Azerbaijan, Uzbekistan, Tajikistan, Turkmenistan
Workshop - CIS Regional Regulatory Strategy
Speakers: Anna Harrington-Morozova Scientific and Regulatory Director Regem Consulting Ltd Anna Harrington-Morozova is a regulatory, drug development and external relations professional with over 20 years' experience gained in regulatory authority, academia, clinical and industry environment. Anna graduated in Russia as a pharmacist. After working in the Russian Ministry of Health and the Clinical Pharmacology Department of Moscow Medical University Anna held regulatory and external relation positions in the pharmaceutical industry and CROs in Russia and the UK, including senior regulatory affairs posts in GSK, EISAI, ICON and PRA. Anna currently acts as a Scientific and Regulatory Director at Regem Consulting Ltd - a regulatory and drug development consultancy with a focus on global regulatory and drug development strategies, advocacy and registrations in emerging markets. For more information about this training visit https://www.researchandmarkets.com/r/v5w5aa
About ResearchAndMarkets.comResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
CONTACT: CONTACT: ResearchAndMarkets.com Laura Wood,Senior Press Manager press@researchandmarkets.com For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900
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