Regulatory Affairs and GMP compliance in Eastern Europe

Considerations for the EAEU and Non-EAEU markets

  • Latest changes in EAEU Upgrade Procedure
  • Experts with local know-how
  • Regulatory/CMC and GMP know-how
  • Officially certified according to ISO 9001 and ISO 21001
Regulatory Affairs and GMP compliance in Eastern Europe

Online-Seminar

Ab 1.990,00 € zzgl. MwSt.
Leistungen & Ablauf

Buchungsdetails

Online-Seminar

Ab 1.990,00 € zzgl. MwSt.
Leistungen & Ablauf

This online training offers comprehensive insights into Regulatory Affairs, CMC, and GMP requirements, with a focus on the latest updates and developments in EAEU countries.

Your speakers

Dr. Edelgard Rehak

Dr. Edelgard Rehak

Dr Edelgard Rehak Consulting, GERMANY

Dr Rehak is an expert on registration and PV in Russia and EAEU. From 2011 to 2014, she has been working as Regulatory Director at Sanofi and Medical Director at…

Dr Galina Senchukova

Dr Galina Senchukova

Independent Regulatory Consultant, RUSSIA

Galina Senchukova is an expert on registration of Drug Products in Russia, EAEU and CIS non-EAEU countries. Before becoming an independent regulatory…

What to Expect

  • Regulatory Framework and Requirements
  • Approval Processes and Documentation
  • Product Management and Maintenance
  • Quality Management and GMP Audits
  • International Markets and Opportunities

Who Should Attend

This seminar is primarily intended for those:

  • Dealing with regulatory affairs or CMC in EAEU countries
  • Preparing for and/or attending GMP inspections in these regions
  • Managing product registrations, renewals, and variations in the EAEU.

Regulatory affairs, CMC, quality, pharmacovigilance and business development staff will particularly benefit from this seminar. It is also highly relevant for professionals involved in clinical trials, technical documentation, and market access in EAEU and non-EAEU countries.

This seminar is tailored for both experienced professionals seeking to deepen their understanding and newcomers aiming to gain essential insights into EAEU regulatory requirements.

Objective of the Event

This seminar is designed to provide a thorough understanding of the regulatory framework and practical requirements for the registration, maintenance, and variation of medicinal products in the Eurasian Economic Union (EAEU). It also addresses critical aspects such as compliance with GMP standards, handling specific requirements for biologicals, and exploring regulatory opportunities in non-EAEU markets.

The seminar aims to equip participants with the knowledge and tools to manage applications, variations and audits efficiently while ensuring adherence to EAEU standards and guidelines.

Your Benefit

  • Understand the EAEU regulatory framework and transition provisions.
  • Learn how to manage applications, variations, and GMP audits effectively.
  • Gain insights into biologicals and biosimilars requirements.
  • Explore compliance opportunities in non-EAEU markets.

Programme

Both days from 09:00 am till 4:00 pm

Day 1

09:00 - 09:15

Welcome

09:15 - 10:15

Introduction
Dr. Edelgard Rehak
  • EAEU Status quo
  • Regulations & Guidelines
  • GXP principles
  • Transition provisions

10:15 - 11:15

New drug applications / Renewals
Dr. Edelgard Rehak
  • MRP / DCP
  • Local Clinical Trials
  • Labelling, SmPC, PIL
  • CTD dossier / eCTD

11:15 - 11:30

Coffee break

11:30 - 12:30

EAEU Upgrade Procedure
Dr. Edelgard Rehak
  • Simplified procedure
  • Module 1 and EAEU PMSF and other PV documents
  • Upgrade & Variations

12:30 - 13:15

Lunch break

13:15 - 14:15

Module 3
Dr Galina Senchukova
  • Module 3
  • EAEU Pharmacopoeia
  • Normative document writing
  • Certificate of analysis

14:15 - 15:00

Biologicals
Dr Galina Senchukova
  • Special requirements for biological medicinal products
  • Biosimilars

15:00 - 15:15

Coffee break

15:15 - 16:00

Maintenance
Dr Galina Senchukova
  • Batch release procedure in RF for chemical and biological medicinal products

16:00

End of Day 1
09:00 - 09:15

Welcome

09:15 - 10:15

Introduction

Dr. Edelgard Rehak

  • EAEU Status quo
  • Regulations & Guidelines
  • GXP principles
  • Transition provisions
10:15 - 11:15

New drug applications / Renewals

Dr. Edelgard Rehak

  • MRP / DCP
  • Local Clinical Trials
  • Labelling, SmPC, PIL
  • CTD dossier / eCTD
11:15 - 11:30

Coffee break

11:30 - 12:30

EAEU Upgrade Procedure

Dr. Edelgard Rehak

  • Simplified procedure
  • Module 1 and EAEU PMSF and other PV documents
  • Upgrade & Variations
12:30 - 13:15

Lunch break

13:15 - 14:15

Module 3

Dr Galina Senchukova

  • Module 3
  • EAEU Pharmacopoeia
  • Normative document writing
  • Certificate of analysis
14:15 - 15:00

Biologicals

Dr Galina Senchukova

  • Special requirements for biological medicinal products
  • Biosimilars
15:00 - 15:15

Coffee break

15:15 - 16:00

Maintenance

Dr Galina Senchukova

  • Batch release procedure in RF for chemical and biological medicinal products
16:00

End of Day 1

Day 2

09:00 - 09:15

Welcome and open questions from day 1

09:15 - 10:00

Variations part 1
Dr Galina Senchukova
  • Legislation
  • Types of variations
  • Safety variations

10:00 - 10:45

Variations part 2
Dr Galina Senchukova
  • Do & Tell variations#Quality variations
  • Grouping

10:45 - 11:00

Coffee break

11:00 - 12:00

GMP Audit
Dr Galina Senchukova
  • Legislation
  • Aim of GMP audits
  • Authorities
  • Process & costs

12:00 - 13:00

Lunch break

13:00 - 14:00

GMP Audit
Dr. Edelgard Rehak
  • Audit preparation #Remote vs on-site

14:00 - 15:00

Overview Non-EAEU Markets
Dr. Edelgard Rehak
  • UA, GE, AZ, MD, UZ

15:00 - 15:15

Coffee break

15:15 - 16:00

Discussion round
Dr. Edelgard Rehak, Dr Galina Senchukova

16:00

End of online seminar
09:00 - 09:15

Welcome and open questions from day 1

09:15 - 10:00

Variations part 1

Dr Galina Senchukova

  • Legislation
  • Types of variations
  • Safety variations
10:00 - 10:45

Variations part 2

Dr Galina Senchukova

  • Do & Tell variations#Quality variations
  • Grouping
10:45 - 11:00

Coffee break

11:00 - 12:00

GMP Audit

Dr Galina Senchukova

  • Legislation
  • Aim of GMP audits
  • Authorities
  • Process & costs
12:00 - 13:00

Lunch break

13:00 - 14:00

GMP Audit

Dr. Edelgard Rehak

  • Audit preparation #Remote vs on-site
14:00 - 15:00

Overview Non-EAEU Markets

Dr. Edelgard Rehak

  • UA, GE, AZ, MD, UZ
15:00 - 15:15

Coffee break

15:15 - 16:00

Discussion round

16:00

End of online seminar

Your options

Are you interested in an in-house training course on topic "Regulatory Affairs and GMP compliance in Eastern Europe"? Please contact us to find out more
Are you interested in broadening your regulatory horizon? This seminar can be booked as part of the qualification course 'Regulatory Affairs Manager', which provides a structured introduction to regulatory affairs while allowing you to set your own focus areas. It combines guided self-study with interactive online seminars to build a solid understanding of regulatory requirements for human medicinal products. Core principles of EU marketing authorisation form the foundation, with the option to deepen your knowledge through additional EU and/or global regulatory affairs online trainings.

Search for the webcode 60012501 on our website for more information and registration or simply click on the link below:
Qualification Course Regulatory Affairs Manager

By booking the qualification course you will save up to 30% compared to individual bookings.

Downloads

Request the documents using our form.

Prospekt

Brochure

Abbreviation List: Drug Regulatory Affairs / CMC

Weitere Informationen


Questions?

You are more than welcome to provide us with your individual questions on the latest developments prior to the scheduled seminar date.

We will be happy to forward them to the speakers, so that they know about your training requirements even better and are able to answer your questions at the seminar.

Please send your questions to v.planitz@forum-institut.de.


Access to and procedure for online events

Once you have registered for an event, we will send you the access information for your customer portal. Click here to log in to the customer portal using your email address and password. Please ensure you can access the customer portal before the day of the event.

All important or additional information and personal documents are available in your personalised customer portal. This is also where you start your online courses. If you do not have access to the customer portal yet, you can easily register here.

On the day of the event, you kick off your online training in the customer portal by clicking ‘Participate’ directly in the respective event. You will then be redirected to the Learning Space.

Learn more about our online events here.


Free pre-meeting and technology check

You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.

The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.


Benefits of a FORUM Institut training course

FORUM Institut’s all-in-one training platform uses the latest teaching methods.
All our online training courses take place in the Learning Space, our holistic learning environment with many features that promote effective and sustainable learning.

  • Live and interactive learning on our Learning Space training platform
  • A platform with many features: events rooms, chat, course agendas and documents, surveys, workshop rooms and much more
  • Easy surveys with Slido
  • ‘Deluxe’ chat: group chats, one-to-one chats, one-to-one video chats
  • A central repository for documents and media
  • Other services and apps such as Padlet and Mentimeter available directly on the platform
  • The perfect marriage of teaching methods and technology
  • High level of interactivity with plenty of opportunity for questions
  • Continuous support throughout the event to ensure the most effective learning
  • Free technical pre-meeting to start off your training on the right foot

In-house Offers - On-site and Online

We also conduct this seminar exclusively for your company - individually tailored to your requirements, flexible scheduling and available as either on-site or online format. Contact us and we will prepare a customized offer for you.

Request a quote

Customer Testimonials

What satisfied participants say

"Many examples, very friendly and interactive."

"Examples out of everyday experience "

Waltraud Jundt-Raubold PHARMA CONSULTING

"Feedback and information based on pracitcal experience of the speakers"

"Very useful, great expertise of speakers"

Sema Gelli-Kaderli OM Pharma SA

"Nice and qualified speakers"

"The discussions and single experiences"

"Very interactive"

"Many new information regarding the CIS"

"Sufficient examples, possibility to ask many questions as we wanted"

"Very interactive, interesting"

"Very organized, very informative, questions were answered "

"Very informative, very good backround of speakers"

"Klarheit und praxisnähe"

"The many practical examples and the comprehensive answers to individual questions from participants"

"very useful for RA managers that already are familiar with some EAEU topics."

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Further Information

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International experts will inform you of the latest trends in global marketing authorisation and drug safety.

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In-house seminars

In-house seminars

Our programmes are also available for in-house training. Just contact us!

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We guarantee the highest quality

We guarantee the highest quality

We are now officially certified to ISO 9001 and ISO 21001 standard.

Details

Your Contact Person

We are happy to advise you personally and individually.

Our further education offerings are comprehensive. We are happy to personally match your requirements with our offerings. Let our further education experts advise you and contact us today.
Verena Planitz

Verena Planitz
Conference Manager
+49 6221 500-655
v.planitz@forum-institut.de