Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union

This interactive course will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation.

2-3 Mar 2020

GBP 1,499 1,299 *
EUR 2,099 1,819 *
USD 2,338 2,026 *
* When you book before 17 Jan

Book now

Course overview

The pharmaceutical markets in Russia, the Eurasian Union and the CIS are of growing commercial importance and companies looking to take advantage of the opportunities available need to be fully up to date with the evolving regulatory landscape, including the potential for market access offered by the latest legislation.

This interactive course will guide you through national procedures as well as exploring the implications of and updates on the Eurasian Union regulation.

The focus of the programme is to offer practical advice in developing your regulatory strategy for product approval in these countries and you will get the full benefit of our trainer’s experience and expertise in the region.

Benefits of attending:

  • Understand the competitive landscape of the growing markets in the CIS region
  • Discover the essential information on the latest regulations and registration procedures in the Eurasian Customs Union
  • Discuss national requirements and guidance for drug approval in the core CIS markets of Russia, Kazakhstan, Belarus, Ukraine and Azerbaijan
  • Develop your CIS regional submission plan and place it within your global regulatory strategy
  • Gain practical advice from an industry expert working in the the CIS region

Why you should attend

Attending this programme will:

  • Give you the full background to the CIS pharmaceutical market
  • Ensure that you understand all the implications of the latest 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
  • 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 all those who need to learn about successful marketing authorisation applications and regulatory compliance in this region. The seminar will be useful either as an introductory or refresher course.

Programme

Russia – competitive landscape

  • Current market and projected growth
  • Pharma 2020 and Health 2020 state programmes
  • Pricing and reimbursement
  • Patent and data protection

Clinical trials in Russia and CIS

  • Russia and CIS in global clinical research
  • Clinical trial requirements
  • Local registrations trials in Russia, CIS and the Eurasian Union

Marketing authorisations in Russia

  • Regulatory authorities in Russia
  • Key regulations governing the MAA process
  • Registration procedures
  • Application dossier requirements

CIS – regional regulatory overview

  • CIS pharmaceutical market
  • CIS regional regulation co-operation – the Eurasian Union
  • CIS regulatory barriers for market access

Marketing authorisations in CIS

  • Eurasian MAA procedure and latest guidances
  • Common regional requirements in CIS

- Administrative data
- Translations
- CPP
- Dossier format
- Local normative documents
- Samples
- Labelling

Country specific requirements for MAAs

- Ukraine, Kazakhstan, Belarus, Moldova, Georgia, Armenia, Azerbaijan, Uzbekistan, Tajikistan, Turkmenistan, Kyrgyzstan

Regional regulatory strategy

  • Workshop – CIS regional regulatory strategy

Discussion sessions will take place throughout the two days

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 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.

Book now

2-3 Mar 2020
2-3 Mar 2020 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 17 Jan*
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
  • AbbVie AG
  • ASTELLAS
  • AstraZeneca
  • Biogen
  • Biogen Idec Ltd., UK
  • Cerbios-Pharma SA
  • Cesra Arzneimittel GmbH & Co. KG
  • Concept Foundation
  • Ferring International Center SA
  • Ferring Pharmaceuticals FICSA
  • Gilead Sciences
  • Horus Pharma
  • LEO Pharma A/S
  • Menarini Ricerche s.p.a
  • Novo Nordisk A/S
  • Pepeliaev Group
  • PRA Health Sciences
  • RB
  • Research and Markets
  • RRG
  • Service Comptabilité
  • Vifor Pharma Ltd.

Anna presented very well and gave great insights into the regulatory processes in the CIS and Russia region.

Jackie Campbell, Senior Regulatory Affairs Associate, Gilead Sciences

Very good

Dimitri Poyer, Associate Regulatory Affairs Director, ASTELLAS

Schedule too tight, better three days than two. "Small" CIS countries have not been discussed due to lack of time. More interactive discussion would be fruitful.

Gunar Hadiprono, Senior Regulatory Affairs Manager International, Cesra Arzneimittel GmbH & Co. KG

Too much information in two days

Adeline Carnet, Service Comptabilité

Informative course, full of content, with a knowledgeable and experienced speaker.

Jessica Bridgewater, GRA Associate, RB