2021-12-22 2022-03-23 , Online Online, 1.790,- € zzgl. MwSt. Dr. Alan A. Chalmers https://www.forum-institut.de/seminarDetail/180/referenten/22/22_03/22032010-course-regulatory-affairs-china-asean-chinese-ctdectd_chalmers-alan-a.jpg Regulatory Affairs China and ASEAN CTD

Three experts will give you an in-depth update on your duties with regard to accepted clinical trial data, dossier submission and the post-approval processes in CHINA. Including the latest eCTD specifications of TAIWAN.

Topics
  • Essential documents for a new application
  • Duties of the National Medical Products Administration (NMPA)
  • Clinical trial application
  • Maintenance duties
  • ASEAN dossier & eCTD in China
  • eCTD in China (goes live Dec 2021!)
Aims and objectives
After having completed these two online seminar days you are aware of the regulatory novelties in China as well as of the dossier compilation challenges in China and the ASEAN countries.

On day one you will learn in detail the points to consider when applying for the marketing authorisation in China and what to keep in mind during the lifecycle of a licenced product.

Day two focusses on the dossier for marketing authorisations in China and the various ASEAN countries. After having completed day two you know the differences of the various formats and know the current status of eCTD submissions in China.
Who should attend

This online seminar addresses the needs of regulatory affairs managers dealing with marketing authorisations in China or the ASEAN countries.

It is also helpful for regulatory / medical affairs managers and business development people who aim to enter one of those markets with their products.

Course Regulatory Affairs China - ASEAN & Chinese CTD/eCTD

Regulatory Affairs China and ASEAN CTD

Benefits
  • Expert know-how on the Chinese market
  • Addional ASEAN know-how
  • Including the latest eCTD specifications of TAIWAN
  • An e-Learning can be booked
  • We are following the IMI quality criteria

Webcode 22032010

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Referenten


Alles auf einen Blick

Termin

22. - 23.03.2022

22. - 23.03.2022

Zeitraum

both days: 09:00-17:00You may dial i...

both days: 09:00-17:00
You may dial in 30 min. before the session
Veranstaltungsort

Online

Online

Gebühr
Ihr Ansprechpartner

Dr. Henriette Wolf-Klein
Head of Department

+49 6221 500-680
h.wolf-klein@forum-institut.de

Details

Three experts will give you an in-depth update on your duties with regard to accepted clinical trial data, dossier submission and the post-approval processes in CHINA. Including the latest eCTD specifications of TAIWAN.

Topics
  • Essential documents for a new application
  • Duties of the National Medical Products Administration (NMPA)
  • Clinical trial application
  • Maintenance duties
  • ASEAN dossier & eCTD in China
  • eCTD in China (goes live Dec 2021!)
Aims and objectives

After having completed these two online seminar days you are aware of the regulatory novelties in China as well as of the dossier compilation challenges in China and the ASEAN countries.

On day one you will learn in detail the points to consider when applying for the marketing authorisation in China and what to keep in mind during the lifecycle of a licenced product.

Day two focusses on the dossier for marketing authorisations in China and the various ASEAN countries. After having completed day two you know the differences of the various formats and know the current status of eCTD submissions in China.

Who should attend

This online seminar addresses the needs of regulatory affairs managers dealing with marketing authorisations in China or the ASEAN countries.

It is also helpful for regulatory / medical affairs managers and business development people who aim to enter one of those markets with their products.

Detailed programme

both days: 09:00-17:00
You may dial in 30 min. before the session

The Chinese market at a glance
  • Heterogeneity of regions
  • Focus on the Chinese market

Clinical trials and clinical trial application in China
  • Different requirements for various trial types, acceptance of foreign clinical study data

Essential documents for a new application
  • Proof of efficacy, safety and quality
  • Required documents and formats including import and local manufacturing

Further steps with regard to a Chinese marketing authorisation
  • Communication with the authorities
  • Keeping track of the rapidly evolving changes to the drug evaluation

Maintenance of the licence
  • Variations; licence renewal

Newest harmonisation efforts in the ASEAN states with regard to the registration dossier
  • ASEAN CTD versus ICH CTD
  • Chinese CTD - the specifics

ASEAN CTD versus ICH CTD - comparison of the two dossier types
  • CMC, clinical and preclinical documents
  • Dossier compilation
  • Practical experience
  • eCTD in China (goes live Dec 2021!) Current specifications Current validation rules How can I prepare?

National specialities in the various ASEAN countries with regard to the CTD


Dossier submission in ASEAN & China
  • Overview ASEAN: Thailand; Singapur; Taiwan

eCTD & electronic submission
  • eCTD in China Current specifications Current validation rules How can I prepare?
  • Overview ASEAN Thailand; Singapur
  • Other Asian countries as Taiwan

More information

Your benefits

  • Three experienced speakers with long year's experience on the Asian market
  • China: Your duties from the New Drug Administration Law addressed in detail
  • Intensive exchange during and after each session
  • Use of live engagement tools to ensure a sustainable learning effect

e-Learning: Common Technical Document & eCTD

Do you lack CTD/eCTD expertise (including CMC know how for CTD module 3)? Then, we would recommend the 'Common Technical Document & eCTD' e-learning programme.

This e-learning programme will provide you with detailed knowledge on the structure and content of the (electronic) common technical document - the only valid dossier format for marketing authorisation applications for human pharmaceuticals in the ICH region.

It will address full as well as abridged dossier application formats, enabling participants to select the data necessary for each application type. Module 3 requirements will be addressed in depth (drug substance and drug product data requirements).

E-learning principles

The e-learning programme 'Common Technical Document & eCTD' comprises four didactic modules that include videos in which the experts Lidia Cánovas and Michael Schaub shares their expertise with you. You can also download and print the corresponding presentation documents.

Each module comprises additional documents (links, guideline texts, etc.) as well as interactive exercises and questions, which help you practise and apply your newly gained knowledge.

Once you have completed the four modules and passed a final multiple-choice test, you will be awarded a certificate, which you can print out directly. The e-learning programme should be completed within three months. Try our e-learning programme for free and familiarise yourself with our learning environment.

How to book the e-learning programme in addition to the seminar

Please register for the seminar "Regulatory Affairs China and ASEAN CTD" by clicking '"Register"'. You will receive a €100 discount if you also book the e-learning programme (you will be billed €490 + local VAT rather than €590 + local VAT).

FAQs/What are the system requirements?

You need a reliable Internet connection and a browser. The following Windows browsers are applicable:

  • Internet Explorer 8 onwards
  • Mozilla Firefox
  • Google Chrome

_______________

We recommend you use the Zoom app to connect with your mobile device.
You will need a headset, loudspeakers or a telephone for audio.

_______________

Can I test my equipment beforehand?
Yes, you can check whether everything will work properly on the day of your online training.
Just click the following link to run a test: https://zoom.us/test

_______________

Do I have to use a headset for the online seminar?
No. In addition to all popular microphones and loudspeakers, Zoom also supports dial-in access by telephone. However, working with a headset is much more convenient for online seminars.

How does an online seminar work?

The Zoom webcasts 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, using the chat function.

1. You will receive brief instructions on how to use Zoom online seminars beforehand.
2. Use a headset, loudspeakers or the telephone for audio.
3. Listen to the speaker and follow the presentation.
4. Use the chat function to ask questions.

The benefits of an online seminar

  • Attend the webcasts in all comfort, from wherever you like
  • There are no travel and accommodation costs
  • Ask questions live, using the chat function

This distinguishes our events

Overall impression: 89 % of the participants' feedback was very good or good (March 2019)

Course content: 89 % of the participants' feedback was very good or good (March 2019)

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List of abbreviations

Many abbreviations are used in all regulatory areas.
Download the list of the most important ones.

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Abbreviations, Glossary
Quality guaranteed!

Your feedback produced as result of 1.8 in 2021. Thank you!

Details
More on our quality criteria

Testimonials

This was well received by the participants and their expectiations in March 2020
Very good introdictiory to the topic.

Dr. Jennifer Neff

bess AG


Thanks for being so fleixibel to change the seminar to virtual instead of cancellation.


I appreciated the presentation of Dr Dressler-Meyer (clearly structured, good summarized)


It is a good opportunity for an overview on regulatory affairs in china and their special requirements. Also gives a lot of information on further ASEAN countries


Thanks for making the virtual event possible!


very skilled experts, but reading of slides

Dr. Christine Causemann

G. Pohl-Boskamp GmbH & Co. KG