Marketing Authorisation in the CIS Countries - Focus: Russia, Belarus, Ukraine, Kazakhstan

- New national drug laws
- Structure and working procedures of the national authorities
- The application dossier - CTD format?
- The application procedure - timeframes, clock stops, fees
- Maintenance of the marketing authorisation - variations, renewals?

Russia, Ukraine, Belarus and Kazakhstan are
often underestimated as attractive markets
for pharmaceuticals. Being located outside
of the European Union, there are different
requirements for pharmaceuticals to receive
a marketing authorisation.

This seminar addresses these requirements:
- What kind of documents do I really need
for the marketing authorisation?
- What do I need to know when
communicating with the national
authorities?
- What do I need to keep in mind as
regards maintaining an existing
marketing authorisation?

Two experts will share their experiences
with you in detail and also address the
changed requirements arising out of new
national drug laws.

Termin

Datum: 27.08.2012
Ort: Pullman Berlin Schweizerhof
Budapester Str. 25
-10787 Berlin
Preis: 950,00 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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Zerfallszeittester / Disintegration Tester DISI
CI SADE Wiegesysteme