Regulatory Affairs China & ASEAN/Chinese CTD -
Seminar / Kurs
von FORUM Institut für Management GmbH
Current Challenges in Marketing Authorisation and Product Maintenance
- Regulatory Affairs in China
- The SDA and further authorities
- Essential documents for a new application
- Clinical trial application
- Maintenance duties - ASEAN/Chinese CTD/eCTD
- CMC, efficacy and safety - data compilation
- National specialities in the various ASEAN countries
- eCTD and eSubmissionTwo 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.
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).
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.
Termine und Orte