FORUM INSTITUT
FORUM · Institut für Management GmbH
Vangerowstraße 18
69115 Heidelberg
E-Mail: service@forum-institut.de
Telefon: +49 6221 500-500
Fax: +49 6221 500-505
Seminare zu Regulatory affairs & vigilance
ASEAN & Chinese CTD/eCTD
Dossier content, format and submission
discussed in detail
2018-03-15 2018-03-15 Fleming's Selection Hotel Frankfurt City Eschenheimer Tor 2 60318 Frankfurt frankfurt-city@flemings-hotels.com +49 69 427 232-0 +49 69 427 232-999

ASEAN & Chinese CTD/eCTD

Dossier content, format and submission discussed in detail

CTD Dossier and submission in Asia, the ASEAN countries and especially China discussed in detail at this seminar
Topics
  • ASEAN CTD; Chinese CTD
  • CMC, efficacy and safety - data compilation
  • National specialities in the various ASEAN countries
  • eCTD and eSubmission

This distinguishes our event

100%
Overall impression: 100 % of the participants' feedback was very good or good (July 2016)
86%
Practical benefit: 86 % of the participants' feedback was very good or good (July 2016)

Aims and objectives

After having completed these two 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 content and dossier type 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 submission in this region. Both seminar days can be booked separately. On day two a regulatory affairs understanding of the Chinese market is presumed (and can be obtained on day one).
Who should attend?
This 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 product.
Your speakers
Dr. Alan A. Chalmers
Pharma International, Innovation Centre, SWITZERLAND

Dr. Mónica Dressler-Meyer
Consultant for Regulatory Affairs, Binningen, SWITZERLAND


Go forward

Our international course portfolio

Our international course portfolio

Are you interested in our international continuous education programme? We provide a variety of specialised courses.

Details

Testimonials

Testimonials

Hear from our past delegates and sponsors and learn more about the events.

Details

More on our quality criteria

Quality guaranteed!

IMI (Innovative Medicines Initiative) defined quality criteria for professional training and education. We follow these criteria and, as a signatory, we are an active partner in further developing and optimising the quality standards. An aggregate evaluation of participants' feedback on all FORUM's healthcare training courses (evaluation period from 10.2015 - 09.2016 produced a result of 1.7 (based on a school grading system of 1-6).

Details