Home»Courses»Implementing the Common Technical Document (CTD) Format for NDA SubmissionsCourse Description
Implementing the Common Technical Document (CTD) Format for NDA Submissions
Course Description
A timely review process depends not only on FDA, but also on sponsors submitting complete and well-organized regulatory applications. This course emphasizes the mechanics of preparing and writing NDAs in the Common Technical Document (CTD) format. Specifically, this course will clarify the rules, regulations and guidelines for how submissions are handled by FDA. Each of the CTD's five modules will be analyzed in detail. In addition, specific strategies for meeting and interacting with FDA personnel are discussed to encourage contact with agency personnel at appropriate points in the various drug development stages. Specific guidelines for the drug approval process, submission preparation and scientific principles are addressed. Upon completion of this two-day course, you will have gained the skills and knowledge necessary to speed new products to market by submitting successful applications.Booking Options
Booking Options:
- Register online or Call Customer Service - Tel: (866) 647-0921 or email register@pti-international.com
- Group Discounts (3 or more people for this course) - Call your Course Guidance Manager at (646) 895-7447 or email CourseManager@pti-international.com
- Bring this Course to Your Facility (10 or more people or further customization) - Call (800) 303-8194 or email OnSiteSolutions@pti-international.com