2024-02-27 2024-02-27 , online online, 1,250 € zzgl. MwSt. Dr. Christina Juli https://forum-institut.de/seminar/24032451-cmc-requirements-in-asia-japan-and-eastern-europe/referenten/24/24_03/24032451-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 2024: 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? 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 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!

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

CMC requirements in
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 24032451

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

anytime

anytime

Zeitraum

12th March, 14th March, 21st March, 28th March 2024
Live webcast from 10:00 am - 12:15 pm
You may dial in 30 minutes before the training starts

12th March, 14th March, 21st March, 28th March 2024
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 2024: 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? 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 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

12th March, 14th March, 21st March, 28th March 2024
Live webcast from 10:00 am - 12:15 pm
You may dial in 30 minutes before the training starts

Dr Christina Juli

12 March 2024: 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

Dr Christina Juli

14 March 2024: 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

Summary and outstandig questions


End of webcast


Welcome and introduction


Dr Galina Senchukova

21 March 2024: 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

Summary and outstandig questions


End of webcast


Welcome and introduction


Prashant Shroff

28 March 2024: 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

Summary and outstandig questions


End of webcast series


Welcome and introduction


Prashant Shroff

28 March 2024: 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
Welcome and introduction round before, Q&A session after each webcast.

Summary and outstandig questions


End of webcast


More information

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

Benefits of a FORUM Institut training course

FORUM Institut’s all-in-one training platform uses the latest teaching methods.
All our online training courses take place in the Learning Space, our holistic learning environment with many features that promote effective and sustainable learning.

  • Live and interactive learning on our Learning Space training platform
  • A platform with many features: events rooms, chat, course agendas and documents, surveys, workshop rooms and much more
  • Easy surveys with Slido
  • ‘Deluxe’ chat: group chats, one-to-one chats, one-to-one video chats
  • A central repository for documents and media
  • Other services and apps such as Padlet and Mentimeter available directly on the platform
  • The perfect marriage of teaching methods and technology
  • High level of interactivity with plenty of opportunity for questions
  • Continuous support throughout the event to ensure the most effective learning
  • Free technical pre-meeting to start off your training on the right foot

Free pre-meeting and technology check

You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.

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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