Regulatory Affairs China - ASEAN & Chinese CTD/eCTD - Marketing Authorisation and Product Maintenance - your duties from the New Drug Administration Law

"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. "