Marketing Authorisation in the Balkan States - Albania, Montenegro, Macedonia, Bosnia + Herzegovina, Serbia and Kosovo
- Scope of the EU pharmaceutical legislation in practice
- Marketing authorisation application in the Balkan States
- Dossier content and CTD format
- Communication with the national authorities
- Maintenance - renewal + variations
Some of the Balkan States belong to
the European Union, while others are
candidates for membership.
This seminar focuses on the regulatory
environment of the non-EU states, e.g.
Albania, Montenegro, Macedonia,
Bosnia + Herzegovina, Serbia and Kosovo
as well as on the new EU member state
Croatia.
You will learn about
- the key factors for a successful
marketing authorisation and
market access
- your tasks regarding the marketing
authorisation application
- your maintenance duties
and will be prepared to successfully
enter the region.
Here you'll get first-hand information
from a local expert!
Termin
| Datum: | 11.09.2015 |
| Ort: | relexa hotel Lurgiallee 2 -60439 Frankfurt |
| Preis: | 990,00 EUR zzgl. MwSt. |
Zielgruppe
This seminar addresses the needs of
managers in the pharmaceutical industry
interested in marketing pharmaceuticals
in the Balkan States.
Especially those working in the following
departments will benefit from this event:
- Regulatory + medical affairs
- Pharmacovigilance
- Business development
Kontaktinformationen
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