FDA: Marketing Authorisation in the U.S. - 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
- Case Study - how FDA approves oncological products

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 about the
IND, NDA and BLA procedures (including up
to date experience with PDUFA V) and the
respective authority meetings.

The speakers will give you firsthand
information on the communication with
the authorities, specialties of the different
procedures and much more.

After having attended this seminar the
participants will be familiar with the critical
points in the marketing authorisation proce-
dures and know how to maintain a granted
marketing authorisation.

Termin

Datum: 09.06.2015
Ort: NH Frankfurt City
Vilbeler Straße 2
-60313 Frankfurt
Preis: 990,00 EUR zzgl. MwSt.
 

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.

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