06.05.11 00:09 Age: -242 Tage
International Events > Pharmaceuticals / Medical devices
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:
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Dr. Raimond Lozda
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FMS Baltic Ltd., Riga, Latvia
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Dr. Edelgard Rehak
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Consultant for Drug Regulatory Affairs Eastern Europe, Maring
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Our Partners / Sponsors
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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.
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Seminar 1105230
Date: 06.05.2011
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Your Contact
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Dr. Henriette Wolf-Klein
Bereichsleiterin Pharma
E-Mail
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Venue:
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Frankfurt
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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.
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Further Information
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Aims and Objectives
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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 in detail.
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 inform you in detail on their experiences.
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- Buchempfehlung
- Masterarbeit zum Thema "Drug Regulatory Affairs and Marketing Authorisation in the Post-Soviet countries. Focus: Russia, The Ukraine and Belarus"
Sprechen Sie mich bei Interesse darauf an - Dr. Henriette Wolf-Klein, Tel. 06221 500 680
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