Presented by
Management Forum

Medical Device Regulation in the Eurasian Union, Russia and the CIS

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.

12-13 Apr 2022 + 2 more dates

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Format: Live online, Classroom
CPD: 12 hours for your records
Certificate of completion

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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

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The Medical Device Regulation in the Eurasian Union, Russia and the CIS course will cover:

Day 1
Day 2

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

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Anna Harrington-Morozova

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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