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Supplements and Other Changes to an Approved Application

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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.
Archive duration:
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

Featured Topics 

  • 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
  • Quality
  • Chemistry, Manufacturing & Controls
  • Technical writing

Learning Objectives 

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

Contact Information 

Printable Registration Form

Registration Questions and
Technical Support

Toll Free 1.888.257.6457
Phone +1.215.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET

Agenda and Event Logistics
Susan Berkelbach, Event Planner
Phone +1.215.442.6183
Fax +1.215.442.6199

Technical Requirements 

Click here for minimum system requirements.

Technical Support
Toll Free 1.888.257.6457
Phone +1.215.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET


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Registration Fees 

Other Fees

Group Site


Charitable Nonprofit/Academia Member Individual
Member Government Individual
Member Standard Individual


Charitable Nonprofit/Academia Nonmember Individual
NonMember Government Individual
NonMember Standard Individual
Registration Information

 Printable Registration Form

  • 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

Group Discounts\Registration

Group Site is a license for one internet and audio log-in, allowing multiple viewers at one physical location. All other fees are for one log-in allowing one viewer.

This online training offering is sold as one complete series and cannot be purchased in parts.

Register Online

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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