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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

Need help?  Enrol or reserve

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

Enrol or reserve

This course will cover:

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

 

 

Enrol or reserve

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 1,299
  • EUR 1,869
  • USD 2,129

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

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

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

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
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
TEOXANE SA

Oct 7 2020

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

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

United Kingdom

  • Abbott Diabetes Care
  • ArjoHuntleigh
  • Biomet UK Healthcare Ltd
  • CooperSurgical
  • Elekta Limited
  • Löwenstein Medical Technology GmbH + Co. KG
  • Thermo Fisher Scientific

Switzerland

  • Biotronik AG
  • Horus Pharma International
  • Nobel Biocare
  • TEOXANE SA
  • Varian Medical Systems International AG

France

  • DKT Woman Care
  • Horus Pharma
  • Septodont

Germany

  • Brainlab AG
  • Löwenstein Medical Technology GmbH + Co. KG
  • Merz Aesthetics GmbH

Sweden

  • Dentsply Sirona
  • HemoCue AB
  • Mölnlycke Health Care AB

Italy

  • Corcym
  • Fidia Farmaceutici S.p.A.

Spain

  • BTI Biotechnology Institute, SL
  • Grifols,S.A.

Belgium

  • Nikkiso Belgium

Czech Republic

  • Rodenstock CR s.r.o.

Denmark

  • William Cook Europe ApS

Finland

  • Santen Oy

Latvia

  • SIA TONUS ELAST

New Zealand

  • Fisher & Paykel Healthcare

Poland

  • LiNA Medical Polska Sp. z o.o.

Russia

  • JSC Thermo Fisher Scientific

United States of America

  • Cepheid

Enrol or reserve

Run Medical Device Regulation in the Eurasian Union, Russia and the CIS Live online for your team

2 days

Typical duration

Pricing from:

  • GBP 800
  • Per attendee, based on 10 attendees
  • Course tailored to your requirements
  • At your choice of location, or online

 

We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, 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

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy