Management Forum Logo

Presented by
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.

★★★★★ "My opinion is overall very positive. I liked how the content was delivered and the knowledgeable spe... more"

18-21 Apr 2023 + 2 more dates

Need help?  Enrol or reserve

  • 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

Enrol or reserve

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

Registration of Medical Devices 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

Workshop: CIS Regional Regulatory Strategy


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

Enrol or reserve

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

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

18-21 Apr 2023

Live online

13:00-16:45 UK (London) (UTC+01)
14:00-17:45 Paris (UTC+02)
08:00-11:45 New York (UTC-04)
Course code 12114

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

Until 14 Mar

View basket 

 
Not ready to book yet?

for 7 days, no obligation

4-5 Jul 2023

Classroom
Rembrandt Hotel
London

09:00-17:00 UK (London)
Course code 12255

  • GBP 1,299 1,499
  • EUR 1,869 2,149
  • USD 2,137 2,449

Until 30 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

View basket 

 
Not ready to book yet?

for 7 days, no obligation

11-12 Dec 2023

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 12371

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

Until 06 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.

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


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.

Jul 5 2022

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

Switzerland

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

United Kingdom

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

France

  • DKT Woman Care
  • Horus Pharma
  • Septodont

Sweden

  • HemoCue AB
  • Mölnlycke Health Care AB

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

Spain

  • BTI Biotechnology Institute, SL

United States of America

  • Cepheid

Enrol or reserve

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

2 days

Typical duration

Pricing from:

  • GBP 800
  • Per attendee
  • 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 expert Aleksandra Beer 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
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy