Dublin, June 18, 2024 (GLOBE NEWSWIRE) -- The "Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union Training Course" conference has been added to ResearchAndMarkets.com's offering.
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
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
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:
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
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 conference visit https://www.researchandmarkets.com/r/ya3wem
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