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.

Course overview

The aim of this course is to provide an overview of recent developments in pharmaceutical regulatory affairs in Russia, the Eurasian Union and the CIS. This interactive course will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation. The focus will be on practical aspects to assist in developing your regulatory strategy for product approval in these countries and the presentations will give practical hints on the regulatory process where possible.

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 the 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 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:

  • Anyone working in pharmaceutical regulatory affairs in this region
  • Anyone interested in an update on recent developments

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

  • New Eurasian MAA procedure
  • 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

Book now

We do not currently have dates confirmed for this course; please contact us to be informed when it is scheduled; or to discuss running this course on an in-house basis for your staff.

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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.

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

Very good

Dimitri Poyer, Associate Regulatory Affairs Director, ASTELLAS

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

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

Jessica Bridgewater, GRA Associate, RB

Too much information in two days

Adeline Carnet, , Service Comptabilité