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Medical Device Regulation in the Eurasian Union, Russia and the CIS Training Course
A comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union. Key countries covered include Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan and Ukraine.
Details
About this programme
The aim of this event is to provide a comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union. This interactive course will cover the regulatory requirements within these regions, focusing on practical aspects to assist in developing your regulatory strategy for product approval. The presentations will also give practical hints on the regulatory and registration process where possible.
Benefits of attending
Attending this programme will:- Give you the full background to the CIS medical device 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
Who should attend?
This seminar will be of particular interest to:- Personnel working in medical device regulatory affairs in this region
- Anyone who is considering marketing a medical device in this region
- Those interested in an update on recent developments
Programme
CIS – regional regulatory overview
- CIS and Russia Market Overview. Market protection policies
- CIS in regional and international Regulatory Harmonisation
Common regional requirements in CIS
- Administrative data, translations, FSC, dossier format, local normative document, samples, labelling
Eurasian regulations for Medical Devices
- Countries current members of EAEU and EAEU Official bodies
- Terms of transition period
- EAEU Registration Procedures. Application process
- EAEU submission documents and data Requirements
- QMS inspections
Registration of Medical Devices in Russia
- Regulatory authorities in Russia and key bodies
- Key regulations governing registration process
- Clinical trials for medical devices
- Registration procedures – what is required?
- Application dossier and data requirements
- Post-approval life cycle maintenance applications
- Safety reporting and market surveillance
Registration of Medical Devices in other EAEU countries
Kazakhstan, Belarus, Armenia, Kirgizstan
Registration of Medical Devices in other CIS countries
- EU sphere of influence: Ukraine, Moldova, Georgia,
- Independent 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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12-13 Apr 2022 Live webinar |
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12-13 Apr 2022 Live webinar |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 8 Mar 22* |
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to attend Live webinar |
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5-6 Jul 2022 Face-to-face, (venue not yet confirmed) |
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5-6 Jul 2022 Face-to-face (venue not yet confirmed) |
GBP 1,499 1,299 EUR 2,099 1,819 USD 2,338 2,026 Until 31 May 22* |
Enrol now
to attend Face-to-face (venue not yet confirmed) |
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12-13 Oct 2022 Live webinar |
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12-13 Oct 2022 Live webinar |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 7 Sep 22* |
Enrol now
to attend Live webinar |
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* Note the early booking discount cannot be combined with any other offers or promotional code