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.
Andrew Willis has over 28 years' of experience in regulatory affairs and pharmaceutical development with specific knowledge in EU and US registrations, CMC regulatory requirements and multiple clinical aspects related to successful registration of drug products.
Previously Vice President of Regulatory Affairs and Consulting Services at Catalent Pharma Solutions, Andrew now works as an independent Regulatory Affairs and Pharmaceutical Development Consultant.
This course has been specifically designed to address the training needs of executives who are or will be involved in the preparation of development plans and/or registration dossiers.