How can you 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? In the challenging environment of US drug registrations procedures, you need to understand all the current procedures. To help you do this, IPT has developed this course to clarify the US regulatory process. By attending, you will gain a practical insight into FDA’s requirements for new drug development and prepare your new drug registration dossier accordingly to US guidelines.

Who Will Attend?
Regulatory Affairs Managers/Officers/Assistants
Compliance Managers
Documentation Managers
Product Registration personnel
Project Managers in Regulatory Affairs
Marketing Managers
Clinical Research Personnel
Key contributors to the submission package for the US market

Course Leader
Carolyn H Kruse, President, KRUSE CONSULTING GROUP, Inc. Caroline has extensive experience in multinational pharmaceutical development – skilled in international and US regulatory affairs, pharmaceutical manufacturing, technology transfer and project management. Caroline has worked for 25 years in the pharmaceutical industry.