Description
How can you be sure to avoid receiving a FDA non-approvable letter? Do you want to be responsible for delaying your drug submission in the USA because you failed to supply the right registration dossier?
Tougher regulatory approval processes pose potential set-backs for pharmaceutical companies registering drugs in the USA . . . can you afford to waste your R&D investment by delaying your product launch? In the challenging environment of US drug registrations procedures, you and your colleagues need to understand all the current procedures. To help you do this, PTI has developed this course that will clarify the US regulatory process. By attending this extensive two day course, you will be able to gain a practical insight into FDA’s requirements for new drug development and prepare your new drug registration dossier accordingly to US guidelines.
