ASEAN + Chinese CTD/eCTD - Dossier content, format and submission discussed in detail
- ASEAN CTD and ICH CTD - differences you should know
- CMC, efficacy and safety - this data needs to be compiled
- Clinical trial application - the basis for a subsequent marketing authorisation
- eCTD and electronic submission - the status quo in the region
This workshop provides you with detailed
knowledge of the current requirements
for clinical trial application documents and
the marketing authorisation application
documents.
After the workshop, you will be familiar
with the current CTD dossier requirements
(ASEAN CTD and Chinese CTD) as well
as the current eCTD effort in the region.
Termin
| Datum: | 07.07.2016 |
| Ort: | Novotel Frankfurt City Lise-Meitner-Str. 2 -60486 Frankfurt |
| Preis: | 990,00 EUR zzgl. MwSt. |
Zielgruppe
This workshop addresses the needs of
regulatory affairs managers dealing with
marketing authorisations in Asia.
A basic understanding of the marketing
authorisation principles in Asia/China is
assumed.
Kontaktinformationen
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