Marketing Authorisation in JAPAN
- Duties and competences of the MHLW and PMDA
- Regulatory requirements for clinical trials
- Details of the application dossier and the application procedure
- Orphan Drug Designations and other initiatives in Japan
Japan is the third-largest pharmaceutical
market in the world and therefore highly
lucrative as a sales market. Although
Japan is part of the ICH region, many
unique local factors need to be taken
into consideration when applying for a
marketing authorisation.
At this seminar two experts in the field
of Japanese regulatory affairs will inform
you on the key regulatory requirements.
After having completed this seminar
you will be aware of the main points to
consider when applying for a marketing
authorisation and will know about the key
challenges and different requirements
compared to Europe.
- What are the procedures and typical
timelines for a marketing authorisation?
- How do I integrate Japan into the global
clinical development program?
- Which additional documents do I need
for pricing?
Take the chance and discuss those and your
individual questions with our local experts.
Termin
| Datum: | 08.10.2015 |
| Ort: | Frankfurt Marriott Hotel Hamburger Allee 2-10 -60486 Frankfurt |
| Preis: | 1.090,00 EUR zzgl. MwSt. |
Zielgruppe
This seminar will be of benefit to all
professionals working in the pharma-
ceutical industry who are interested
in marketing pharmaceuticals in Japan.
Especially those working in regulatory
affairs and clinical trials will profit
from the seminar.
Kontaktinformationen
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