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
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 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).
It is also helpful for regulatory / medical affairs managers and business development people who aim to enter one of those markets with their products.
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
86%
Overall impression: 86 % of the participants' feedback was very good or good (March 2018)
86%
Course content: 86 % of the participants' feedback was very good or good (March 2018)
86%
Practical benefit: 86 % of the participants' feedback was very good or good (March 2018)
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 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 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 products.
Your speakers
Dr. Alan A. Chalmers
Pharma International,
Innovation Centre, SWITZERLAND
Dr. Mónica Dressler-Meyer
Consultant for Regulatory Affairs, Binningen, SWITZERLAND
