Medical Device Regulation in the Eurasion 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.

2-3 Oct 2019

GBP 1,499 1,299 *
EUR 2,099 1,819 *
USD 2,338 2,026 *
* When you book before 16 Aug

Book now

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.

Beneftis 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

Day one - Russia

Russia – the competitive landscape

  • Current market and projected growth
  • Heath 2020 state program
  • Localisation of manufacturing
  • Pricing and reimbursement
  • Patent and data protection

National standards

  • Technical requirements and standards in key regions

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

Day two - CIS and EAEU

CIS – regional regulatory overview

  • CIS pharmaceutical market
  • CIS in International Regulatory Harmonisation
  • CIS regional regulatory co-operation – Eurasian Economic Union

Eurasian regulations for medical devices

  • Countries – members of EAEU, official bodies and terms of transition period
  • EAEU data requirements
  • EAEU registration procedures

Registration of medical devices in CIS

  • Common regional requirements in CIS
    • Administrativedata,translations, FSC, dossier format, local normative document, samples, labelling
  • Country specific requirements
    • Ukraine, Kazakhstan, Belarus, Moldova, Georgia, Armenia, Azerbaijan, Uzbekistan, Tajikistan, Turkmenistan, Kyrgyzstan

Practical workshop

  • CIS regional regulatory strategy

Presenter

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 as a Scientific and Regulatory Director at Regem Consulting Ltd – a regulatory and drug development consultancy with a focus on global regulatory and drug development strategies, advocacy and registrations in emerging markets.

Book now

2-3 Oct 2019
2-3 Oct 2019 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 16 Aug*
Enrol now

* Note the early booking discount cannot be combined with any other offers or promotional code

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Previous customers include...

  • Abbott Diabetes Care
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  • Biotronik AG
  • Horus Pharma
  • Mölnlycke Health Care AB
  • Research and Markets
  • William Cook Europe ApS

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

Anette Hulstrøm, Specialist Regulatory Affairs, William Cook Europe ApS

Great

Helen Finn, Regulatory Affairs Coordinator, ArjoHuntleigh