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

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:

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.

More details

Book Medical Device Regulation in the Eurasian Union, Russia and the CIS Live online/Classroom training

12-13 Apr 2022

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 11906

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 08 Mar

In your basket 

5-6 Jul 2022

Classroom
London venue TBC

09:00-17:00 UK (London)
Course code 11397

  • GBP 1,299 1,499
  • EUR 1,819 2,099
  • USD 2,026 2,338

Until 31 May

  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

In your basket 

12-13 Oct 2022

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 11749

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 07 Sep

In your basket 

Reviews of IPI's Medical Device Regulation in the Eurasian Union, Russia and the CIS training course


My opinion is overall very positive. I liked how the content was delivered and the knowledgeable speaker.

Oct 7 2020

Monica Fabris
Regulatory Affairs Expert, Fidia Farmaceutici S.p.A.

Oct 4 2017

Content is very good. Speakers are also well prepared and competent

Anette Hulstrøm
Specialist Regulatory Affairs, William Cook Europe ApS

Oct 4 2017

Great

Helen Finn
Regulatory Affairs Coordinator, ArjoHuntleigh

UK

  • Abbott Diabetes Care
  • ArjoHuntleigh
  • Biomet UK Healthcare Ltd
  • Thermo Fisher Scientific

France

  • DKT Woman Care
  • Horus Pharma
  • Septodont

Sweden

  • HemoCue AB
  • Mölnlycke Health Care AB

Switzerland

  • Biotronik AG
  • Nobel Biocare

Czech Republic

  • Rodenstock CR s.r.o.

Denmark

  • William Cook Europe ApS

Finland

  • Santen Oy

Germany

  • Brainlab AG

Italy

  • Fidia Farmaceutici S.p.A.

Poland

  • LiNA Medical Polska Sp. z o.o.

Russia

  • JSC Thermo Fisher Scientific

United States of America

  • Cepheid

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Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy