Considerations for the EAEU and Non-EAEU markets
Webcode 25082500
Dr. Edelgard Rehak
Dr Edelgard Rehak Consulting, GERMANY
Dr Rehak is an expert on registration in Russia and Central and Eastern Europe. From 2011 to 2014, she worked 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.
She has a broad range of experience in bioequivalence and toxicological trials in Russia. Until 2006, she held several positions in product development (Gx and biosimilars) and clinical research at Sandoz/HEXAL, Germany.
More information please click here.
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.
28-29/08/2025
28-29/08/2025
Each day from 09:00 am - 4:00 pm - online seminar
You may dial in 30 minutes before the training starts
online
online
Veranstaltung - 1,990 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Veranstaltung - 1,990 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Verena Planitz
Conference Manager
+49 6221 500-655
v.planitz@forum-institut.de
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.
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.
Welcome
Dr. Edelgard Rehak
Dr. Edelgard Rehak
Coffee break
Dr. Edelgard Rehak
Lunch break
Dr Galina Senchukova
Dr Galina Senchukova
Coffee break
Dr Galina Senchukova
End of Day 1
Welcome and open questions from day 1
Dr Galina Senchukova
Dr Galina Senchukova
Coffee break
Dr Galina Senchukova
Lunch break
Dr. Edelgard Rehak
Dr. Edelgard Rehak
Coffee break
Dr. Edelgard Rehak, Dr Galina Senchukova
End of online seminar
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.
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.
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.
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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
