FDA: Marketing Authorisation in the USA - Update on the IND, NDA + BLA procedures
- US FDA regulations in comparison with the EU law
- The FDA drug registration in detail
- Communication with the FDA
- Marketing authorisation granted - the arising duties
- The Electronic Drug Registration and Listing System
Do you plan to apply for a marketing
authorisation for your product in the
USA? Then an early start in the
cooperation with the US FDA is essential.
This seminar informs you in detail on the
IND, NDA and BLA procedures and the
necessary meetings with the FDA in the
context of these procedures.
The speakers will give you firsthand
information on the communication with
the authorities, specialties of the different
procedures and much more.
May I invite you to join this meeting and
profit from the outstanding experience
of the speakers?
Termin
| Datum: | 25.04.2012 |
| Ort: | Ameron Hotel Regent Melatengürtel 15 -50933 Köln |
| Preis: | 860,00 EUR zzgl. MwSt. |
| Link: | http://www.forum-institut.de/fileadmin/pdf/1204232.pdf |
Zielgruppe
This seminar addresses the needs of
managers in the pharmaceutical industry.
Especially those working in the following
departments will benefit from this event:
- Regulatory + medical affairs
- Business development
Needless to say, those who plan to enter
the US market with their pharmaceuticals
will get useful hints for a successful
marketing authorisation.
Kontaktinformationen
Weitere Pharma-Seminare - Ameron Hotel Regent ,Melatengürtel 15,-50933 Köln
