Marketing Authorisation in RUSSIA/the CIS Countries - Russia, Belarus, Ukraine and Kazakhstan in focus
- Current changes in the respective national drug laws
- Structure and working procedures of the national authorities
- The application dossier - format and content
- The application procedure - timeframes and fees
- Maintenance - renewals and variations
The CIS countries are attractive markets for
pharmaceuticals. Coming from the EU -
which differing national requirements
(covered by the respective drug laws) have
to be fulfilled? Which regulatory novelties
have to be kept in mind?
Two local experts give you a thorough
update on the status quo in the countries
and the upcoming changes.
After having completed the seminar you
will be familiar with the current regulatory
framework and have an understanding
regarding
- essential documents (marketing
authorisation + maintenance)
- procedures
- communication with the authorities
- local specialities, etc.
On day two you will have the chance to go
into even further detail on Russia. Dr. Rehak
will be happy to discuss with you current
obstacles in regulatory affairs in case
studies. Your own cases are highly welcome.
Termin
Datum: | 21.08.2014 |
Ort: | Novotel Berlin Am Tiergarten Straße des 17. Juni 106-108 -10623 Berlin |
Preis: | 1.590,00 EUR zzgl. MwSt. |
Zielgruppe
This seminar will be of benefit to all those working in the pharmaceutical industry who are interested in marketing pharmaceuticals in the CIS countries. Especially those working in regulatory affairs will profit from the seminar.
Kontaktinformationen
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