; Course Regulatory Affairs China - ASEAN & Chinese CTD/eCTD
2021-12-22 2022-03-23 , Online Online, 1.790,- € plus tax Dr. Alan A. Chalmers https://www.forum-institut.com/seminar/22032010-regulatory-affairs-china-and-asean-ctd/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
  • We are following the IMI quality criteria

Webcode 22032010

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

22. - 23.03.2022

22. - 23.03.2022

Period

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

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

Online

Online

Fee
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

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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Testimonials
Quality guaranteed!

Your feedback produced as result of 1.7 in 2020. Thank you!

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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