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Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union Training Course
This interactive course will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation.
15-16 Aug 2022
Details
Course overview
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 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.
Programme
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 document, 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 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
Presenter
Anna Harrington-Morozova (More...)
Anna Harrington-Morozova is a regulatory, drug development and external relations professional with over 20 years’ experience gained working in a Regulatory Authority, academia and industry. Anna graduated in Russia as a pharmacist. After working in the Russian Ministry of Health and the Clinical Pharmacology Department of Moscow Medical University, she 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 a a Scientific and Reguatory director at Regem Consulting Ltd – a consultancy which focuses on drug development, global regulatory advice, professional trainings and flexible resourcing solutions for the pharmaceutical, biotech and medical device industries in emerging markets.
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NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate
- 40% off the 3rd delegate
- 50% off the 4th delegate
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15-16 Aug 2022 Live webinar 09:00-17:00 UK (London) |
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15-16 Aug 2022 Live webinar 09:00-17:00 UK (London) |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 11 Jul* |
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to attend Live webinar |
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* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.