Supplements and Other Changes to an Approved Application
Continuing Education Credits are not available for the archived offering.
This program is a part of DIA's Certificate Program and is awarded the following:
Regulatory Affairs Certificate Program: 1 Elective Units
For more information go to www.diaglobal.org/certificateprograms
This archive may be purchased through June 9, 2015.
Part 1: 59 minutes
This online course will discuss the practical use of Supplemental Applications and how they affect changes to an approved new drug application (NDA) or biologic license application (BLA).
Course Level: Beginner
- Regulatory Requirements for NDAs and BLAs
- How to Make Appropriate Changes to An Approved Application
- Post-approval submissions to FDA
Who should attend?
Professionals who work in the areas of:
- Regulatory Affairs
- Chemistry, Manufacturing & Controls
- Technical writing
At the conclusion of this activity, participants should be able to:
- Discuss the post-approval regulatory requirements for NDAs and BLAs
- Recognize the differences between major, moderate, and minor changes to an approved application
- Describe how post-approval changes are submitted to FDA
Registration Questions and
Toll Free 1.888.257.6457
Monday-Friday 8:30AM-8:00PM ET
Agenda and Event Logistics
Susan Berkelbach, Event Planner
Ways to register
- Individual registration is a license for ONE internet login allowing one viewer.
- Group site registration is a license for ONE internet login allowing multiple viewers from one location.
Cancellations: No refunds will be provided in the event of a participant’s cancellation since all costs for this webinar have been prepaid by DIA. DIA reserves the right to modify or cancel programs and/or substitute presenters or panelists. DIA is not responsible for failure to deliver programs due to circumstances beyond its control.
Participants with Disabilities: Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs