FDA: Marketing Authorisation in the U.S. - Update on the IND, NDA + BLA procedures

Forum Institut für Management
In Köln

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Wichtige informationen

Tipologie Seminar
Ort Köln
Dauer 1 Tag
  • Seminar
  • Köln
  • Dauer:
    1 Tag

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.


Wo und wann

Beginn Lage
auf Anfrage
Helenenstr. 14, 50667, Nordrhein-Westfalen, NRW, Deutschland
Karte ansehen
Beginn auf Anfrage
Helenenstr. 14, 50667, Nordrhein-Westfalen, NRW, Deutschland
Karte ansehen

Was lernen Sie in diesem Kurs?



- 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

Zusätzliche Informationen

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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