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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.

★★★★★ "The workshop was very useful. I really liked the presentation and the content. The experience has be... more (10)"

6-7 February 2025
+ 19-20 June 2025, 2-3 October 2025 »
from £1099

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Format: Live online
CPD: 12 hours for your records
Certificate of completion

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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 CIS region

This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.

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.

Enrol or reserve

This course will cover:

Day 1
Day 2

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

Enrol or reserve

Anna Harrington-Morozova
Regem Consulting Ltd

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

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

6-7 February 2025

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 14495

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

Until 02 Jan

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

19-20 June 2025

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 14768

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

Until 15 May

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

2-3 October 2025

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 14967

GBP 1,099 1,299
EUR 1,616 1,896
USD 1,817 2,129

Until 28 Aug

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

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; and apply only when booking multiple delegates on the same date.

Reviews of IPI's Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union training course

I found this webinar really helpful and informative. Thank you for organising this webinar and a very special thanks to the speaker.

Oct 3 2024

Ayse Gulden Oztekin Turkey
International Markets Regulatory Affairs Coordinator, Recordati Ilac Sanayi ve Ticaret Anonim Sirketi

Feb 4 2021

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

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

Feb 4 2021

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 Spain
Regulatory Affairs Technician, Grifols S.A.

Feb 4 2021

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 Spain
Regulatory Affairs Technician, Grifols S.A.

Mar 2 2020

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 Switzerland
Regulatory Compliance Leader, GSK Consumer Healthcare

Feb 23 2017

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

Jackie Campbell United Kingdom
Senior Regulatory Affairs Associate, Gilead Sciences

Feb 23 2017

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

Jessica Bridgewater United Kingdom
GRA Associate, RB

Feb 23 2017

Very good

Dimitri Poyer Netherlands
Associate Regulatory Affairs Director, ASTELLAS

Feb 23 2017

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