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Basics of the NDA

Oct 22 2013 12:00PM - Oct 31 2013 1:30PM | Online

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This six-part online training series will discuss the practical aspects of NDA submission preparation.

Featured Topics 

  • The practical steps required to prepare an NDA
  • Review postapproval activities

Who Should Attend 

  • New regulatory affairs professionals
  • Business and marketing professionals
  • Clinical researchers
  • Biostatisticians
  • Basic researchers
  • Quality professionals
  • Medical writers

Learning Objectives 

At the conclusion of this activity, participants should be able to:

  • Recognize content and format requirements for NDA/BLA in the Common Technical Document Format
  • Define postapproval requirements
  • List characteristics of adequate and well controlled trials

Special Offers 

Register More than One Group Site and Save 15%!

Contact Information 

Registration Questions
Vicki Adkinson, Customer Service Associate
Phone +1.215.442.6162
Fax +1-215.442.6199

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

Technical Requirements 

Click here for minimum system requirements.


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Continuing Education 

Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 1760 Old Meadow Road, Suite 500, McLean, VA 22102 (703) 506-3275.

As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer .9 CEUs for this program. Participants must attend the entire program in order to be able to receive an IACET statement of credit. No partial credit will be awarded.

This program is part of DIA’s Certificate Program and is awarded the following.
• Regulatory Affairs Certificate Program: 6 Core Units each

For more information go to www.diahome.org/certificateprograms

Name Credit Type Max Credits CEU
Basics of the NDA IACET 9.00 0.900

Disclosure Policy:

It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.

Statement of Credit:

Continuing education credits are available to learners who participate in the live online training course. To request credit, complete the on-line credit request process through My Transcript at www.diahome.org.

Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests two weeks after the last day of the activity.

Continuing education credits are available to learners who participate in the live online training course. Continuing education credits and DIA’s Certificate Program units are not available for participation in the archived version of the online training course.

To view DIA’s Grievance Policy, please visit the CE page on the DIA website at www.diahome.org/CE


Day 1 Tuesday, October 22, 2013

  • 12:00PM - 1:30PM

    Part 1: The NDA in CTD Format

Day 2 Wednesday, October 23, 2013

  • 12:00PM - 1:30PM

    Part 2: The NDA in CTD Format - Modules 1-5

Day 3 Thursday, October 24, 2013

  • 12:00PM - 1:30PM

    Part 3: The NDA in CTD Format - Modules 1-5 (continued)

Day 4 Tuesday, October 29, 2013

  • 12:00PM - 1:30PM

    Part 4: The NDA in CTD Format - Submission

Day 5 Wednesday, October 30, 2013

  • 12:00PM - 1:30PM

    Part 5: The NDA in CTD Format - Submission (continued)

Day 6 Thursday, October 31, 2013

  • 12:00PM - 1:30PM

    Part 6: Post-NDA Approval Regulatory Requirements

Registration Fees 

Other Fees

Group Site Webinar Registration
Group Site


Charitable Nonprofit/Academia Member Individual
Member Government Individual
Member Individual


Charitable Nonprofit/Academia Nonmember Individual
NonMember Government Individual
NonMember Individual
Group Discounts

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.

*Receive a 15% discount on the entire purchase when you register for more than one group site at the same time. Valid only when group sites are purchased online for this training series.

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

Register Online
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