Marketing authorisation in Japan - Drug marketing authorisation in Japan - MHLW, PMDA, KIKO
- Duties and competences of the MHLW, PMDA and KIKO
- Details of the application dossier and the application procedure for Generics and NCEs
- Regulatory requirements for clinical trials
- Maintenance of the marketing authorisation: variations + renewals
Japan is one of the largest pharmaceutical
markets and therefore highly lucrative as
a sales market. The precondition for this is
a national marketing authorisation. Although
Japan is part of the ICH region, many unique
local factors need to be taken into conside-
ration.
This seminar covers the main points to keep
in mind, from the regulatory requirements in
clinical trials to the content and format of
the application dossier, up to the mainten-
ance of the marketing authorisation.
Two experts in the field of Japanese
regulatory affairs will inform you in detail
with regard to Generics and NCEs.
Termin
| Datum: | 14.05.2012 |
| Ort: | Lindner Hotel Residence Main Plaza Walther-von-Cronberg-Platz 1 -60594 Frankfurt |
| Preis: | 890,00 EUR zzgl. MwSt. |
| Link: | http://www.forum-institut.de/fileadmin/pdf/1205230.pdf |
Zielgruppe
This seminar will be of benefit to all working
in the pharmaceutical industry who are
interested in marketing pharmaceuticals in
Japan. Especially those working in regu-
latory affairs and clinical trials will profit
from the seminar.
Kontaktinformationen
Weitere Pharma-Seminare - Lindner Hotel Residence Main Plaza,Walther-von-Cronberg-Platz 1,-60594 Frankfurt
