2021-12-01 2021-12-01 , Online Online, 1.190,- € zzgl. MwSt. Dr. Christina Juli https://www.forum-institut.de/seminar/22032450-cmc-requirements-in-asia-japan-and-eastern-europe/referenten/22/22_03/22032450-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? Contact us!

Topics
  • Pharmaceutical documentation
  • Additions and differences with regard to ICH requirements
  • Country specific requirements
  • Practical experiences (e.g. MAA, renewal, variations)
  • Avoiding typical mistakes in the dossier, common pitfalls
Aims and objectives
During this live webcast series you will learn about the specific CMC requirements for China, India, Japan, 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.
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.

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
  • This expertise will benefit your company
  • We follow the IMI quality criteria

Webcode 22032450

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

anytime

anytime

Zeitraum

10 March, 17 March, 24 March, 31 Mar...

10 March, 17 March, 24 March, 31 March
each from 10:00 am - 12:15 pm
Veranstaltungsort

Online

Online

Downloads
Gebühr
Ihr Ansprechpartner

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? Contact us!

Topics
  • Pharmaceutical documentation
  • Additions and differences with regard to ICH requirements
  • Country specific requirements
  • Practical experiences (e.g. MAA, renewal, variations)
  • Avoiding typical mistakes in the dossier, common pitfalls
Aims and objectives

During this live webcast series you will learn about the specific CMC requirements for China, India, Japan, 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.

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.

Detailed programme

10 March, 17 March, 24 March, 31 March
each from 10:00 am - 12:15 pm

10:00 Welcome and introduction round


10:10

Jack Wong

10 March 2022: 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 in the dossier, common pitfalls

12:00 Q&As


12:15 End of webcast


10:00 Welcome and introduction round


10:10

Pooja Maingi

17 March 2022: 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 in the dossier, common pitfalls

12:00 Q&As


12:15 End of webcast


10:00 Welcome and introduction round


10:10

Dr Christina Juli

24 March 2022: CMC requirements in Japan and Southkorea
  • Pharmaceutical documentation
  • Additions and differences with regard to ICH requirements
  • Country specific requirements
  • Practical experiences (e.g. MAA, renewal, variations)
  • Avoiding typical mistakes in the dossier, common pitfalls

12:00 Q&As


12:15 End of webcast


10:00 Welcome and introduction round


10:10

Dr Galina Senchukova

31 March 2022: 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 in the dossier, common pitfalls

12:00 Q&As


12:15 End of webcast series


More information

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.

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

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