FDA: Marketing Authorisation in the U.S. - Update on the IND, NDA + BLA proceduresForum Institut für Management
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
Erfolge des Zentrums
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.