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
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.