Global CMC requirements: focus on Asia, Japan, and Eastern Europe
Covering aspects for small and large molecules
- Local expertise
- Practical CMC know-how for emerging markets
- Pose your questions prior to the training
- Officially certified according to ISO 9001 + 21001
Online-Seminar
From
1.350,00 €
plus VAT
Services & Process
Veranstaltung - 1.350,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
from 09:00 am until 05:00 pm CET
You may dial in 30 minutes before the lecture starts
Booking details
Online-Seminar
From
1.350,00 €
plus VAT
Services & Process
Veranstaltung - 1.350,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
from 09:00 am until 05:00 pm CET
You may dial in 30 minutes before the lecture starts
CMC requirements in China, Japan, South Korea, India and Russia/EAEU. Meet our three experts to get an update on the current requirements in the different regions and discuss your individual issues with them. Contact us!
Your speakers
Dr. Christina Juli
Boehringer Ingelheim International GmbH
Biberach an der Riss, GERMANY
Head of CMC, CCM RA Office NBE
Dr. Christina Juli studied pharmacy at the University of Wuerzburg, Germany. After her PhD thesis in…
Your speaker
Dr. Christina Juli
Boehringer Ingelheim International GmbH
Biberach an der Riss, GERMANY
Head of CMC, CCM RA Office NBE
Dr. Christina Juli studied pharmacy at the University of Wuerzburg, Germany. After her PhD thesis in the fields of pharmaceutical chemistry, in 2012, she joined ratiopharm GmbH in Ulm, Germany and started her professional career as Senior Manager in the department of EU Regulatory Affairs Generic Maintenance.
From 2018 to 2025, she was working at the manufacturing site for biopharmaceuticals in Biberach, Germany as Head of CMC Management CMB where she focused on the CMC development for biologics for the contract manufacturing business of Boehringer Ingelheim.
In her current role as Head of CMC RA Office NBE, she focuses on the CMC development for biologics and is responsible for CMC regulatory topics of development projects, products, and strategic regulatory projects.
Beyond that she is an active participant of several industry groups such as the BioPhorum Operations Group (Post Approval Strategy and Regulatory Governance working groups) or EFPIA.
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.
Prashant Shroff
AstraZeneca Pharma India Pvt. Ltd.,
Begaluru, INDIA
He has worked at CDSCO (Zonal office of Indian Govt. Authority) as a Technical Data Associate. He started his professional journey in the private…
Your speaker
Prashant Shroff
AstraZeneca Pharma India Pvt. Ltd.,
Begaluru, INDIA
He has worked at CDSCO (Zonal office of Indian Govt. Authority) as a Technical Data Associate. He started his professional journey in the private sector with Sun Pharmaceutical Ind. Ltd. in 2016 and then he joined Pharmalex India Pvt. Ltd. Currently, he is working as Regulatory Affairs Manager at AstraZeneca Pharma India Pvt. Ltd.
In his career, he has well-versed experience for the Indian registration procedures for drug products as well biologicals covering regulatory strategy throughout the life cycle management, documentation, pharmacopoeial compliance, labelling, package inserts etc.
What to Expect
- Regions covered: China, Japan, South Korea, India, Russia/EAEU
- Pharmaceutical legislation
- Additions and differences with regard to ICH requirements
- Practical experiences (e.g. MAA, renewal, variations)
- and more
Who Should Attend
This course will be of benefit to all those working in the pharmaceutical industry, particularly CMC and regulatory affairs managers, who are dealing with dossier compilation (quality data/module 3) for the regions China, Japan, South Korea, India, and Russia/EAEU.
Aspects for small and large molecules will bei considered.
Objective of the Event
During this training you will learn about the specific CMC requirements in China, Japan, South Korea, India, and Russia/EAEU.
Three (local) experts will share valuable information regarding
- pharmaceutical documentation;
- country specific requirements;
- reliance procedure/fast track approval;
- avoidance of typical mistakes.
After the training you will have gained a better understanding of the additional and differing CMC-related requirements and procedures in the different regions.
You will benefit from know-how that allows you to "speed-up" your approval processes.
Your Benefit
The feedback of participant's from former courses:
- "Expectations fully meet; content requested delivered in presentations; "good inside - lessons learned"
- "Lecture on Russia: interesting, helpful weblinks, examples, requirements; lecture on Asia: very interesting; lecture on India: slides very helpful"
- "Satisfied with all lectures/presentations; China: interactive, first-hand information; Japan/South Korea: all fine; India: accompanying slides helpful; Russia/EAEU: all fine"
Programme
10 September 2026
from 09:00 am until 05:00 pm CET
Dr Christina Juli
- Pharmaceutical legislation
- Additions and differences with regard to ICH requirements
- Country-specific requirements
- Reliance procedures
- Practical experiences (e.g. MAA, renewal, variations)
- Avoiding typical mistakes, common pitfalls
Dr Christina Juli
- Pharmaceutical legislation
- Additions and differences with regard to ICH requirements (South Korea)
- Country-specific requirements
- Reliance procedures
- Practical experiences (e.g. MAA, renewal, variations)
- Avoiding typical mistakes, common pitfalls
Prashant Shroff
- Pharmaceutical legislation
- Additions and differences with regard to ICH requirements
- Country-specific requirements
- Reliance procedures/fast track approval
- Practical experiences (e.g. MAA, renewal, variations)
- Avoiding typical mistakes, common pitfalls
Dr Galina Senchukova
- Pharmaceutical legislation
- Additions and differences with regard to ICH requirements
- Country-specific requirements
- Practical experiences (e.g. MAA, renewal, variations)
- Avoiding typical mistakes, common pitfalls
Welcome, introduction, expectations
CMC requirements in China
CMC requirements in China
Dr Christina Juli
- Pharmaceutical legislation
- Additions and differences with regard to ICH requirements
- Country-specific requirements
- Reliance procedures
- Practical experiences (e.g. MAA, renewal, variations)
- Avoiding typical mistakes, common pitfalls
Biobreak
CMC requirements in Japan and South Korea
CMC requirements in Japan and South Korea
Dr Christina Juli
- Pharmaceutical legislation
- Additions and differences with regard to ICH requirements (South Korea)
- Country-specific requirements
- Reliance procedures
- Practical experiences (e.g. MAA, renewal, variations)
- Avoiding typical mistakes, common pitfalls
Lunch break
CMC requirements in India
CMC requirements in India
Prashant Shroff
- Pharmaceutical legislation
- Additions and differences with regard to ICH requirements
- Country-specific requirements
- Reliance procedures/fast track approval
- Practical experiences (e.g. MAA, renewal, variations)
- Avoiding typical mistakes, common pitfalls
Biobreak
CMC requirements in Russia/EAEU
CMC requirements in Russia/EAEU
Dr Galina Senchukova
- Pharmaceutical legislation
- Additions and differences with regard to ICH requirements
- Country-specific requirements
- Practical experiences (e.g. MAA, renewal, variations)
- Avoiding typical mistakes, common pitfalls
End of seminar
Downloads
Request the documents using our form.
Brochure
List of abbreviations - Drug Regulatory Affairs/CMC
Weitere Informationen
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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.
Our Recommendations
Further Information
Your Contact Person
We are happy to advise you personally and individually.
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de