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Management Forum

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.

★★★★★ "I liked how structured it was and that it was practical and we could ask specific questions. The exe... more"

9-10 December 2024
+ 3-4 April 2025, 23-24 July 2025, 8-9 December 2025 »
from £1099

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Format: Live online
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.

This course is of our range of Medical Devices training courses - now also including Medical Devices Cyber Security training to help improve your data security.

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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This course will cover:

Day 1
Day 2

Russia and CIS – Regional Regulatory Overview

Russia and CIS Market Overview
Market protection policies
CIS in regional and international
Regulatory
Harmonisation

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 MDs in Russia

Regulatory authorities in Russia
Key regulations governing registration process
Clinical trials for medical devices
National registration procedures

Registration of MDs in Russia (continued)

Application dossier and data requirements
Post approval life cycle maintenance applications
Safety reporting and market surveillance
Price and reimbursement
Patent data protection

Common regional requirements in CIS

Administrative data, translations, normative document, samples, labelling

Registration of MDs in other CIS countries

Other EAEU members: Kazakhstan, Belarus, Armenia, Kirgizstan
EU harmonisation: Ukraine, Moldova, Georgia,
National procedures: Azerbaijan, Uzbekistan, Tajikistan, Turkmenistan

Workshop – CIS Regional Regulatory Strategy

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Anna Harrington-Morozova
Regem Consulting Ltd

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

NEW higher discounts for multiple bookings - 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*

Please contact us for pricing if you are interested in booking 5 or more delegates

9-10 December 2024

Live online

09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 14072

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 04 Nov

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

3-4 April 2025

Live online

Course code 14618

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 27 Feb

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

23-24 July 2025

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 14791

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 18 Jun

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

8-9 December 2025

Live online

09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 15134

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 03 Nov

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.

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

I liked how structured it was and that it was practical and we could ask specific questions. The exercises at the end were interesting as well.

Jul 2 2024

Iulia-Catalina Vladu Germany
Regulatory Affairs Manager, Merz Aesthetics GmbH

Jul 5 2022

Speaker was really good and easy to understand for a non-native english speaker as I am. Organization of webinar was perfect. The assistance attendent was here for us in case of any problems. Content was complete and detailed as awaited. Good speaker and very friendly.

Arberite Mjaku Switzerland
TEOXANE SA