Marketing Authorisation in RUSSIA/the CIS Countries - Russia, Belarus, Ukraine and Kazakhstan in focus

- Significant legislation changes in RUSSIA and Ukraine
- 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 have
to be fulfilled? Which regulatory novelties
have to be kept in mind (especially in Russia
and Ukraine)?

Two 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: 20.08.2015
Ort: ARCOTEL John F Berlin
Werderscher Markt 11
-10117 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.

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Zerfallszeittester / Disintegration Tester DISI