2025-04-03 2025-04-03 , online online, 1,350 € zzgl. MwSt. Dr. Christina Juli https://forum-institut.de/seminar/25092451-global-cmc-requirements-focus-on-asia-japan-and-eastern-europe/referenten/25/25_09/25092451-seminar-pharma-cmc-requirements-in-asia,-japan,-eastern-eu_juli-christina.jpg Global CMC requirements: focus on Asia, Japan, and Eastern Europe

Four live webcasts à 2 hours every week: CMC requirements in China, India, Japan, South Korea and Russia/EAEU. Meet our four experts to get an update on the current requirements in the different regions and discuss your individual issues with them. You are interested in one webcast only or a group account? Contact us!

Topics
  • Concept: Four weekly live webcasts à 2 hours with longtime experienced speakers
  • Regions covered: China India Japan/South Korea Russia/EAEU
  • Your benefits: Possibility to directly interact with the speaker; You will receive a certificate after each session; You are unable to attend one of the sessions? Profit from the recording of each webcast!


Who should attend
This series 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, India, Japan/South Korea and Russia/EAEU.

The webcast series will cover aspects for small and large molecules.
Aims and objectives
During this webcast series you will learn about the specific CMC requirements in China, India, Japan/South Korea and Russia/EAEU.

Four (local) experts will share valuable information regarding
  • pharmaceutical documentation,
  • country specific requirements and
  • 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.
Your benefit

  • Meet three (local) experts that will share in-depth knowledge with you!
  • Obtain practical CMC know-how for emerging markets!
  • Integrate the webcast sessions conveniently into your daily work routine!
  • Missed a live session? No problem! Make profit from the recording that is available after each individual webcast!

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

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

- Online Training -

Benefits
  • Local expertise
  • Pose your questions prior to the training
  • 4 webcasts à 2h: convenient to integrate into your work routine
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 25092451

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

16/09/-07/10/2025

16/09/-07/10/2025

Zeitraum

16, 23, and 30 September + 07 October 2025
Live webcast from 10:00 am - 12:15 pm
You may dial in 30 minutes before the training starts

16, 23, and 30 September + 07 October 2025
Live webcast from 10:00 am - 12:15 pm
You may dial in 30 minutes before the training starts
Veranstaltungsort

online

online

Downloads
Gebühr
Your contact

Dr. Birgit Wessels
Conference Manager

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

Details

Four live webcasts à 2 hours every week: CMC requirements in China, India, Japan, South Korea and Russia/EAEU. Meet our four experts to get an update on the current requirements in the different regions and discuss your individual issues with them. You are interested in one webcast only or a group account? Contact us!

Topics

  • Concept: Four weekly live webcasts à 2 hours with longtime experienced speakers
  • Regions covered: China India Japan/South Korea Russia/EAEU
  • Your benefits: Possibility to directly interact with the speaker; You will receive a certificate after each session; You are unable to attend one of the sessions? Profit from the recording of each webcast!


Who should attend
This series 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, India, Japan/South Korea and Russia/EAEU.

The webcast series will cover aspects for small and large molecules.

Aims and objectives

During this webcast series you will learn about the specific CMC requirements in China, India, Japan/South Korea and Russia/EAEU.

Four (local) experts will share valuable information regarding

  • pharmaceutical documentation,
  • country specific requirements and
  • 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.

Your benefit

  • Meet three (local) experts that will share in-depth knowledge with you!
  • Obtain practical CMC know-how for emerging markets!
  • Integrate the webcast sessions conveniently into your daily work routine!
  • Missed a live session? No problem! Make profit from the recording that is available after each individual webcast!

Detailed programme

16, 23, and 30 September + 07 October 2025
Live webcast from 10:00 am - 12:15 pm
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

23.09.2025 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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