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Frankfurt, 06.05.2011

Marketing authorisation in the CIS countries

Focus: Russia, Belarus, Ukraine, Kazakhstan

  • Structure and working procedures of the national authorities

  • The application dossier - CTD format?

  • SmPC and package leaflet

  • The application procedure - timeframes, clock stops, fees

  • Maintenance of the marketing authorisation - variations, renewals?

Your Speakers:

Dr. Raimond Lozda
Dr. Raimond Lozda
FMS Baltic Ltd., Riga, Latvia
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Dr. Edelgard Rehak
Dr. Edelgard Rehak
Consultant for Drug Regulatory Affairs Eastern Europe, Maring
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Our Partners / Sponsors
ECV Guide

ECV Guide

Herausgeber: ECV - Editio Cantor Verlag You can use various sources to draw up marketing authorisation applications, but if you are not sure what exactly you are looking for, it is easy to get lost in the sheer abundance of information and lose valuable time. In contrast, the Guide to Drug Regulatory Affairs eases you through the necessary procedures, comments on EU and EMEA documents and helps you draw up your application.

Link


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Seminar 1105230

Date: 06.05.2011

Your Contact

Dr. Henriette Wolf-Klein
Bereichsleiterin Pharma
E-Mail


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Venue:

Frankfurt
Steigenberger Airport Hotel
Unterschweinstiege 16
60549 Frankfurt

Tel. +49 69 6975-0
Fax +49 69 6975-2505

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Fee:
890,- EUR zzgl. MwSt.

Further Information
Aims and Objectives
Buchempfehlung