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Overview

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: 6 Core Units
For more information go to www.diaglobal.org/certificateprograms

This archive may be purchased through May 6, 2015.
Archive duration:
Part 1: 1 hour 20 minutes
Part 2: 1 hour 26 minutes
Part 3: 1 hour 18 minutes
Part 4: 1 hour 22 minutes
Part 5: 1 hour


Learn about FDA regulations and expectations for the content, submission, and review of Investigational New Drug (IND) Products and the importance of regulatory strategy. The course focuses on drug and well characterized biological products and not the regulatory process for devices, generic products, or traditional biologics.

Course Level: Beginner

Featured topics

  • The fundamentals of the Investigational New Drug Products
    • Preparation
    • Content
    • Strategy
  • Activities and submissions required to maintain an IND
  • Special Regulatory Considerations for Clinical Development

Who should attend?

  • Regulatory affairs professionals new to the IND process
  • Clinical research and development professionals
  • Biostatisticians
  • Basic researchers
  • Quality and manufacturing professionals
  • Medical writers
  • Business professionals
  • Project Managers

Learning objectives

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

  • Explain the importance of incorporating regulatory strategy into the drug development plan
  • Describe the FDA review processes for evaluating INDs
  • Plan and prepare an IND, and know the reporting requirements for IND amendments
  • Identify regulatory mechanisms to facilitate development of new therapies

Contact us

 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
CustomerService@diahome.org

Agenda and Event Logistics
Susan Berkelbach, Event Planner
Phone +1.215.442.6183
Fax +1.215.442.6199
Susan.Berkelbach@diahome.org

Ways to register

 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