2025-11-01 2025-11-01 , online online, 1,350 € zzgl. MwSt. Dr. Christina Juli https://forum-institut.de/seminar/26042452-global-cmc-requirements-focus-on-asia-japan-and-eastern-europe/referenten/26/26_04/26042452-seminar-pharma-cmc-requirements-in-asia,-japan,-eastern-eu_juli-christina.jpg Global CMC requirements: focus on Asia, Japan, and Eastern Europe

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!

Topics
  • 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.
Aims and objectives
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 course you will have gained a better understanding of the additional and differing CMC-related requirements and procedures in the different regions.
You are more then welcome to provide individual questions prior to the course.
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"

Seminar pharma - CMC requirements in Asia, Japan, Eastern EU

Global CMC requirements: Focus
on Asia, Japan & Eastern Europe

- Online training -

Benefits
  • Local expertise
  • Practical CMC know-how for emerging markets
  • Pose your questions prior to the training
  • Officially certified according to ISO 9001 + 21001

Webcode 26042452

Jetzt buchen

JETZT Buchen
Referenten

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 the ratiopharm GmbH in Ulm, Germany. She started her professional career as Senior Manager in the department of EU Regulatory Affairs Generic Maintenance. Since 2018, she is working in the Tech RA department at Boehringer Ingelheim Pharma GmbH & Co. KG in Biberach, Germany. In her role as Head of CMC Management CMB, she focuses on the CMC development for biologics and is responsible for the definition, compilation and review of the CMC documentation for clinical trial and new drug applications as well as for post approval submissions worldwide. Beyond that, as regulatory intelligence responsible for her business unit, she monitors the regulatory legislation, regulations, guidelines and position papers from pharmaceutical and biological industry worldwide. She is an active participant in the BioPhorum Operations Group (Post Approval Strategy and Regulatory Governance working groups).

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 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.

Alles auf einen Blick

Termin

28/04/2026

28/04/2026

Zeitraum

from 09:00 am until 05:00 pm CET
You may dial in 30 minutes before the training starts

from 09:00 am until 05:00 pm CET
You may dial in 30 minutes before the training starts
Veranstaltungsort

online

online

Downloads
List of abbreviations - Drug Regulatory Affairs/CMC
List of abbreviations - Drug Regulatory Affairs/CMC
Gebühr

Veranstaltung - 1,350 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.

Veranstaltung - 1,350 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.

Inhouse-Angebote
Inhouse-Angebot anfordern
Inhouse-Angebot anfordern

Jetzt buchen

Your contact

Dr. Birgit Wessels
Conference Manager

+49 6221 500-652
b.wessels@forum-institut.de

Details

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!

Topics

  • 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.

Aims and objectives

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 course you will have gained a better understanding of the additional and differing CMC-related requirements and procedures in the different regions.
You are more then welcome to provide individual questions prior to the course.

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"

Detailed programme

from 09:00 am until 05:00 pm CET
You may dial in 30 minutes before the training starts

16.09.2025 10:00 - 12:15

Dr Christina Juli

CMC requirements in China
  • 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
  • Summary and outstandig questions

24.09.2025 10:00 - 12:15

Dr Christina Juli

CMC requirements in Japan and South Korea
  • 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
  • Summary and outstandig questions

30.09.2025 10:00 - 12:15

Dr Galina Senchukova

CMC requirements in Russia/EAEU
  • 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
  • Summary and outstandig questions

07.10.2025 10:00 - 12:15

Prashant Shroff

CMC requirements in India
  • 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
  • Summary and outstandig questions

More information

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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.

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