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Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union Training Course

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

3-4 Feb 2022

& 15-16 Aug 2022

Book now

Details

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

CIS – regional regulatory overview

  • CIS and Russia Market Overview
    • Market protection policies
  • CIS and Russia in regional and international Regulatory Harmonisation

Common regional requirements in CIS

  • Administrative data, translations, normative document, samples, labelling, etc

Eurasian economic area

  • Countries current members of EAEU and EAEU Official bodies
  • History of EUAE, scope of products, available experience
  • Terms of transition period for medicines

Eurasian Regulations for Medicines

  • Overview of EAEU regulatory framework
  • Registration Procedures and Application process
  • EAEU submission documents and data requirements
  • GMP inspections
  • PhV requirements

Registration of Medicine in Russia

  • Regulatory authorities in Russia
  • Key regulations governing registration process
  • Clinical trials

National Regulatory Procedures in Russia

  • Application dossier and data requirements
  • Post approval life cycle maintenance applications
  • Safety reporting and market surveillance
  • Price and reimbursement
  • Patent data protection

Registration in other EAEU countries

  • Kazakhstan, Belarus, Armenia, Kirgizstan

Registration in other CIS countries

  • EU sphere of influence: Ukraine, Moldova, Georgia
  • National procedures: Azerbaijan, Uzbekistan, Tajikistan, Turkmenistan

Workshop – CIS Regional Regulatory Strategy

Presenter

Anna Harrington-Morozova (More...)

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

Book now

3-4 Feb 2022
Live webinar
3-4 Feb 2022
Live webinar
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 30 Dec*
Enrol now
to attend
Live webinar
15-16 Aug 2022
Live webinar
15-16 Aug 2022
Live webinar
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 11 Jul 22*
Enrol now
to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

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

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

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Previous customers include...

  • Abbott
  • AbbVie AG
  • Actelion Pharmaceuticals Ltd.
  • ASTELLAS
  • AstraZeneca
  • Atnahs Pharma UK limited
  • Biogen
  • Biogen Idec Ltd., UK
  • Bristol Myers Squibb
  • Cerbios-Pharma SA
  • Cesra Arzneimittel GmbH & Co. KG
  • Concept Foundation
  • Ferring International Center SA
  • Ferring Pharmaceuticals FICSA
  • Fidia Farmaceutici S.p.A.
  • Gilead Sciences
  • Grifols S.A.
  • GSK Consumer Healthcare
  • 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.

The Webinar contains useful information and it is very interesting but there is a lot of information for only two-day course.

Silvia Santano Hernandez, Regulatory Affairs Technician, Grifols S.A., Feb 21

My goal was to obtain a clear picture of the situation in the Eurasian countries and the changes that we can find in the legislation for the registration of medicinal products in comparison to the national legislations and yes, I accomplished this.

Silvia Santano Hernandez, Regulatory Affairs Technician, Grifols S.A., Feb 21

The workshop was very useful. I really liked the presentation and the content. The experience has been very rewarding.

Monica Fabris, Regulatory Affairs Expert, Fidia Farmaceutici S.p.A., Feb 21

Anna is very knowledgeable not only in the regulatory affairs field but she also knows very well the Russian culture and ways of working and was therefore able to put some information into perspective by providing a historico-socio-political context.

Sylvie Barchéchath, Regulatory Compliance Leader, GSK Consumer Healthcare, Mar 20

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, Feb 17

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, Feb 17

Very good

Dimitri Poyer, Associate Regulatory Affairs Director, ASTELLAS, Feb 17

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

Jessica Bridgewater, GRA Associate, RB , Feb 17

Too much information in two days

Adeline Carnet, Service Comptabilité, Feb 17