- email:registration@pti-europe.co.uk
- phone:+44 (0) 20 7017 7481
US-FDA Drug Submission Procedures
Course Objectives
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.
What Will You Learn?
- Submit complete dossiers by understanding the critical elements of US INDs and NDAs
- Meet the data requirements for INDs and NDAs
- Communicate better with the FDA by knowing the organisational structure of the Agency and the interactions within the agency
- Work your way through the laws and regulations governing the registration of prescription drugs in the US
- Know how to obatain information from the FDA
- Understand the logistics of the sponsor-FDA interactions
Event Highlights
- Achieve faster drug registration in the US and be ‘first, to market’ to win market share
- Clarify the needs, expectations and regulatory requirements of the FDA for the drug registration dossier
- Prepare successful Investigational New Drug Applications (INDs) & New Drug Applications (NDA)
Who Should Attend
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.
- 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
Reviews
"A complete vision of drug registration"
Related Events
Intermediate Level Adverse Event Reporting
08 Dec 2010 - 09 Dec 2010
Regus Trafalgar Square, London, UK
Dates and Venues
09 Sep 2010 - 10 Sep 2010
Regus St James's Park, London, UK
Connect with the PTI faculty! PTI is a global pharmaceutical training company with over 60 interctive courses focusing on Regulatory Affairs, R&D, Clinical, Business Strategy, Fine Chemicals, Biopharmaceuticals, Manufacturing, Medical Devices and Agrochemicals
