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
Online-Seminar
From
1.990,00 €
plus VAT
Services & Process
Veranstaltung - 1.990,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
Each day from 09:00 am - 4:00 pm - online seminar
You may dial in 30 minutes before the training starts
Booking details
Online-Seminar
From
1.990,00 €
plus VAT
Services & Process
Veranstaltung - 1.990,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
Each day from 09:00 am - 4:00 pm - online seminar
You may dial in 30 minutes before the training starts
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 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…
Your speaker
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 Zentiva, based in Moscow, and prior to that, from 2006 to 2009, as Head Regulatory and QA for Novartis, based in Kiev, Ukraine. Until 2006, she held several positions in product development and clinical research at Sandoz/HEXAL, Germany.
She offers consultancy services in registration of medicinal products and PV in Russian and EAEU.
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…
Your speaker
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 consultant, in 2017-2024 she worked as Regulatory and Quality Assurance Head at CSL Behring and in 2013-2017 - as Regulatory Head at Sanofi Pasteur in Russia. Before that she worked on different regulatory positions at Sanofi, MSD and GSK.
PhD in Pharmaceutical Chemistry, advanced RA professional with about 18 years hands-on experience in Rx, biological and biotechnological products registration (blood plasma products and vaccines), mostly specializing in CMC area. Together with her local team achieved many successful registration of Drug Products in complicated and challenging regulatory environment.
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
09:15 - 10:15
Dr. Edelgard Rehak
- EAEU Status quo
- Regulations & Guidelines
- GXP principles
- Transition provisions
10:15 - 11:15
Dr. Edelgard Rehak
- MRP / DCP
- Local Clinical Trials
- Labelling, SmPC, PIL
- CTD dossier / eCTD
11:15 - 11:30
11:30 - 12:30
Dr. Edelgard Rehak
- Simplified procedure
- Module 1 and EAEU PMSF and other PV documents
- Upgrade & Variations
12:30 - 13:15
13:15 - 14:15
Dr Galina Senchukova
- Module 3
- EAEU Pharmacopoeia
- Normative document writing
- Certificate of analysis
14:15 - 15:00
Dr Galina Senchukova
- Special requirements for biological medicinal products
- Biosimilars
15:00 - 15:15
15:15 - 16:00
Dr Galina Senchukova
- Batch release procedure in RF for chemical and biological medicinal products
16:00
Welcome
09:15 - 10:15
Introduction
Introduction
Dr. Edelgard Rehak
- EAEU Status quo
- Regulations & Guidelines
- GXP principles
- Transition provisions
10:15 - 11:15
New drug applications / Renewals
New drug applications / Renewals
Dr. Edelgard Rehak
- MRP / DCP
- Local Clinical Trials
- Labelling, SmPC, PIL
- CTD dossier / eCTD
Coffee break
11:30 - 12:30
EAEU Upgrade Procedure
EAEU Upgrade Procedure
Dr. Edelgard Rehak
- Simplified procedure
- Module 1 and EAEU PMSF and other PV documents
- Upgrade & Variations
Lunch break
13:15 - 14:15
Module 3
Module 3
Dr Galina Senchukova
- Module 3
- EAEU Pharmacopoeia
- Normative document writing
- Certificate of analysis
14:15 - 15:00
Biologicals
Biologicals
Dr Galina Senchukova
- Special requirements for biological medicinal products
- Biosimilars
Coffee break
15:15 - 16:00
Maintenance
Maintenance
Dr Galina Senchukova
- Batch release procedure in RF for chemical and biological medicinal products
End of Day 1
Day 2
09:00 - 09:15
09:15 - 10:00
Dr Galina Senchukova
- Legislation
- Types of variations
- Safety variations
10:00 - 10:45
Dr Galina Senchukova
- Do & Tell variations#Quality variations
- Grouping
10:45 - 11:00
11:00 - 12:00
Dr Galina Senchukova
- Legislation
- Aim of GMP audits
- Authorities
- Process & costs
12:00 - 13:00
13:00 - 14:00
Dr. Edelgard Rehak
- Audit preparation #Remote vs on-site
14:00 - 15:00
Dr. Edelgard Rehak
- UA, GE, AZ, MD, UZ
15:00 - 15:15
15:15 - 16:00
Dr. Edelgard Rehak, Dr Galina Senchukova
16:00
Welcome and open questions from day 1
09:15 - 10:00
Variations part 1
Variations part 1
Dr Galina Senchukova
- Legislation
- Types of variations
- Safety variations
10:00 - 10:45
Variations part 2
Variations part 2
Dr Galina Senchukova
- Do & Tell variations#Quality variations
- Grouping
Coffee break
11:00 - 12:00
GMP Audit
GMP Audit
Dr Galina Senchukova
- Legislation
- Aim of GMP audits
- Authorities
- Process & costs
Lunch break
13:00 - 14:00
GMP Audit
GMP Audit
Dr. Edelgard Rehak
- Audit preparation #Remote vs on-site
14:00 - 15:00
Overview Non-EAEU Markets
Overview Non-EAEU Markets
Dr. Edelgard Rehak
- UA, GE, AZ, MD, UZ
Coffee break
Discussion round
End of online seminar
Your options
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.
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
Customer Testimonials
What satisfied participants say
Our Recommendations
Further Information
Your Contact Person
We are happy to advise you personally and individually.
Verena Planitz
Conference Manager
+49 6221 500-655
v.planitz@forum-institut.de