2022-11-29 2022-11-29 , online online, 1,250 € zzgl. MwSt. Dr. Christina Juli https://www.forum-institut.de/seminar/23032451-cmc-requirements-in-asia-japan-and-eastern-europe/referenten/23/23_03/23032451-training-course-cmc-requirements-in-asia,-japan,-eastern-eu_juli-christina.jpg CMC requirements in Asia, Japan and Eastern Europe

Four live webcasts à 2 hours every week in March 2022: 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 (local) experts
  • 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? Benefit 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 small molecules and biologics too.
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!

Training course - CMC requirements in Asia, Japan, Eastern EU

CMC requirements in
Asia, Japan and Eastern Europe

- Online training -

Benefits
  • First-hand information, local expertise
  • Pose your questions prior to the training
  • Four single webcasts à 2h - convenient to integrate into your work routine
  • We follow the IMI quality criteria

Webcode 23032451

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

anytime

anytime

Zeitraum

1st March, 7th March, 15th March, 22...

1st March, 7th March, 15th March, 22th March 2023
live webcast from 10:00 am - 12:15 pm
You may dial in 30 minutes before the training starts.
Veranstaltungsort

online

online

Gebühr
Ihre Kontaktperson

Dr. Birgit Wessels
Konferenzmanagerin Healthcare

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

Details

Four live webcasts à 2 hours every week in March 2022: 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 (local) experts
  • 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? Benefit 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 small molecules and biologics too.
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

1st March, 7th March, 15th March, 22th March 2023
live webcast from 10:00 am - 12:15 pm
You may dial in 30 minutes before the training starts.

10:00 Welcome, expectations, introduction round


10:10

Jack Wong

1 March 2023: CMC requirements in China
  • Pharmaceutical documentation
  • Additions and differences with regard to ICH requirements
  • Country-specific requirements
  • Practical experiences (e.g. MAA, renewal, variations)
  • Avoiding typical mistakes, common pitfalls

12:00 Summary and outstandig questions


12:15 End of webcast


10:00 Welcome and introduction


10:10

Dr Christina Juli

7 March 2023: CMC requirements in Japan and South Korea
  • Pharmaceutical documentation
  • Additions and differences with regard to ICH requirements (South Korea)
  • Country-specific requirements
  • Practical experiences (e.g. MAA, renewal, variations)
  • Avoiding typical mistakes, common pitfalls

12:00 Summary and outstandig questions


12:15 End of webcast


10:00 Welcome and introduction


10:10

Prashant Shroff

15 March 2023: CMC requirements in India
  • Pharmaceutical documentation
  • Additions and differences with regard to ICH requirements
  • Country-specific requirements
  • Practical experiences (e.g. MAA, renewal, variations)
  • Avoiding typical mistakes, common pitfalls

12:00 Summary and outstandig questions


12:15 End of webcast


10:00 Welcome and introduction


10:10

Dr Galina Senchukova

22 March 2023: CMC requirements in Russia/EAEU
  • Pharmaceutical documentation
  • Additions and differences with regard to ICH requirements
  • Country-specific requirements
  • Practical experiences (e.g. MAA, renewal, variations)
  • Avoiding typical mistakes, common pitfalls

12:00 Summary and outstandig questions


12:15 End of webcast series


More information

Webcast series: CMC requirements in MENA regions (23012450)

You are working with affiliates or external partners in MENA?

Four (local) experts will share their in-depth knowledge on CMC requirements in these regions (focus Levant (Morocco, Tunisia, Jordan, Lebanon, Iraq), GCC, Türkiye, Iran and Egypt) with you - webcasts scheduled weekly in January 2023.

For more information visit our website using the webcode 23012450.

Webcast series: CMC requirements in Latin America (23042453)

You are working with affiliates or external partners in Latin America?

Three (local) experts will share their in-depth knowledge on CMC requirements in this region with you (focus Mexico, Brazil, Colombia, Argentina, Chile, Peru, CAMCAR (Central America and Caribbean) - webcasts scheduled weekly in April/May 2023.

For more information visit our website using the webcode 23042453.

How does an online seminar work?

Our online training courses are live and interactive. They are held and controlled directly by our speaker. You may take part in the seminar from anywhere using your end device. You will see the presentation and listen to our speaker's lecture using Internet telephony (VoIP) or even a normal telephone connection. And you can also ask questions live.

  • You will find brief instructions on how to use Zoom, your course documentation, the access link and a meeting ID in your personal customer account.
  • Use a headset, loudspeakers or the telephone for audio.
  • Listen to the speaker and follow the presentation.
  • Feel free to switch from silent to audio mode by yourself any time to ask your questions.

The benefits of an online seminar

  • Attend the training in all comfort, from wherever you like
  • There are no travel and accommodation costs
  • Ask questions live whenever you desire

Send us your individual questions

Please send us your questions concerning the seminar topics in advance.

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 b.wessels@forum-institut.de

This distinguishes our events

Overall score of all evaluations in 2021

Five stars on Trustpilot = Excellent

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