MR + Decentralised Procedure - Your Regulatory Strategy

- Essential points in the presubmission phase
- The submission: country specialities!
- Multiple/duplicate applications - with case studies
- Delaying and accelerating factors
- E-Submission - eAF + CESP

You are involved in the regulatory strategy
and/or submission management? Then you
should not miss out this event. Here you will
get firsthand information on the dos and
don'ts in the presubmission phase and after
having submitted the application.

Two highly experienced speakers will give
you hints how to optimise your regulatory
strategy and at the same time will inform
you on the regulatory novelties in terms of
transparency, pharmacovigilance and
much more.

After having completed this seminar you
will be able to optimise your next application
and have the latest information on the
(E-)submission of documents.

Termin

Datum: 16.09.2014
Ort: Hilton Hotel
Berliner Freiheit 2
-53111 Bonn
Preis: 950,00 EUR zzgl. MwSt.
 

Zielgruppe

This seminar will be of benefit to everyone
working in regulatory affairs in the
pharmaceutical industry. Those dealing
with regulatory strategy and submission
management will particularly benefit from
the seminar.

Familiarity with the MR- and DC-procedures
is assumed.

Kontaktinformationen

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